THE ABUSE OF ANTIDIARRHEAL AGENTS AND ANTIMICROBIAL DRUGS IN THE TREATMENT

OF INFANT DIARRHEA IN MEXICO

A Report Prepared by PRITECH Consultant ROBERTO F UNDA MD MPH

During The Pericd OCTOBER 1 - 0 1986

TECHNOLOGIES FOR PRIMARY HEALTH CARE (PRITECH) PROJECT Supported By The

US Agency for International Development AIDDPE-5927-C-00-3083-00

AUTHORIZATION AIDSampTHEA 33087 ASSGN NO DC 229

CONTENTS

Pagre

2 I Medications Which Affect Intestinal Motility

7 II Drugs with Antisecretory Properties

8 III Aciduric Bacteria

9 IV Medicines With Absorptive Effects

Supplement Informal Survey of Medications for Diarrhea Sold in Pharmacies in Mexico City and Outskirts

References

Annex I Questionnaire for Mothers Who Will Buy Medications to Treat Infant Diarrhea in Different Pharmacies in Mexico City and Outskirts

Annex II List of Essential Drugs Mexican Health Sector (1984)

Annex III Sample Drug Advertising

Annex IV Basic Medications for Diarrhea in Mexico

The problem of infant diarrhea has been known in Mexico from

ancient times Historically children received innumerable

treatments in the form of home remedies varying from purgatives

to different teas made from special herbs with medicinal properties

(1)

In the era of modern medicine these home remedies have been

replaced by antibiotics and the so-called antidiarrheal agents

of which the following are notable for their frequent use

1 drugs which affect intestinal motility

2 drugs with antisecretory properties

3 and drugs which promote absorption

In spite of the great worldwide popularity of antibiotics and

antidiarrheals (2) this article will review the scientific

literature with respect to the inefficacy of these agents in the

treatment of acute infant diarrhea The concepts governing the

treatment of infant diarrhea are not applicable in all cases to the

management of travelers diarrhea

According to the World Health Organization (3) there are

three main types of diarrhea 1) acute watery diarrhea in which

the stools are white or liquid but not bloody 2) dysenteric

diarrhea in which the stools contain mucus and blood and 3)

chronic or persistent diarrhea which begins as an acute episode

but lasts longer than 21 days

The main complications of diarrhea are dehydration and tissue

catabolism which contribute to malnutrition and which can be

aggravated when food is withheld from children as part of the

treatment

-1ishy

Diarrheal therapy should be designed in a practical manner

for the prevention and correction of dehydration maintenance of

nutrition and treatment of dysentery

A vast number of treatments are commercially available today

the majority of which are sold widely throughout Mexico Selfshy

medication is so popular that the majority of the products are

sold without medical prescription in pharmacies dispensed on

occasion by people totally uninformed about the potential risks of

these products (20)

The majority of these medicines claim to reduce the volume of

stools and shorten the illness but none has proved to be safe and

sufficiently effective to be used regularly in young children

I MEDICATIONS WHICH AFFECT INTESTINAL MOBILITY

The opiates and their derivatives are widely used

antidiarrheal drugs which act primarily through their

antimotility properties Included are codeine tincture of

opium (all alkaloids) and diphenoxilate and loperamide (both

synthetic opium derivatives)

Loperamide is the most widely sold antidiarrheal drug in

the world having captured more than 10 of the world market

in 1983-1984 (4) More than a dozen pharmaceutical companies

produce drugs that ccntain loperamide

This drug acts on the muscles of the intestinal wall and

diminishes the movement of the intestinal contents in a

fashion similar to the opiates

According to Lancet only a few pediatric studies on

loperamide have been performed to date and none has shown

- 2 shy

that loperamide is effective In studies carried out in the

United Kingdom and in Libya loperamide did not reduce the

duration of the diarrhea or the length of hospital stay nor

did it improve weight gain in children up to four years old

who suffered from acute infectious diarrhea (5) Loperamide

is potentially harmful if used in the treatment of infectious

diarrhea caused by bacteria or amoebas because it can

prolong diarrhea and lead to a mistaken diagnosis of the

severity of the illness (6) In addition it can cause

perforation of the intestinal wall (7) In the United

Kingdom the manufacturer has admitted that the effectiveness

and safety of loperamide in acute infectious diarrhea has not

been proven (8)

Nevertheless this has not prevented some pharmaceutical

companies from manufacturing medicines containing loperamide

and advertising them without precautions or warnings in their

promotional messages

According to standards clearly set by the Control of

Diarrheal Disease Program of the World Health Organization

none of these medications is recommended for use in young

children due to the undesirable side effects they can cause

and the fact that the dangers are greater than the modest

benefit derived in the majority of cases (3) All can cause

nausea vomiting lethargy and paralytic ileus and can even

lead to cardiopulmonary arrest Tests with loperamide

(024 mgskgday) did not demonstrate any clinical effect of

statistical significance in the daily stool volume or of the

fluids required for rehydration in spite of the fact that the

duration of diarrhea was moderately diminished (14 15) One

larger -aily dose (048 mgskg) caused a modest although

statistically significant reduction in the length of the

diarrheal episode Nevertheless before the diarrhea stopped

the rate of stool fluid loss was not affected (16 3)

indicating that this drug has 1o antisecretory properties of

clinical benefit in watery diarrheas (2) Consequently

loperamide does not appear on the list of essential drugs of

World Health Organization

The American Medical Association advises against the use

of this drug in children under twelve and clearly lists as

possible side effects toxic megacolon and intestinal

perforation in acute infectious diarrhea In the United

States this medicine is sold only by prescription (9)

Due to all of these factors many developing countries

have placed regulations -o control or eliminate loperamideshy

containing medicines from their markets in recent years

For example Bangladesh decided to eliminate these from the

market after a thorough analysis of these drugs side effects

(10) The Philippines has recently decided to impose strong

restrictions on their use (10)

Another popular remedy medicines containing diphenoxylate

such as Lomotil (diphenoxilate with atropine sulfate) can

worsen the clinical course of infectious diarrheas

It has been clearly documented that the use of drugs with

diphenoxilate causes prolonged fever and difficulty in excretion

of the pathogenic agent in volunteers infected with Shigella

- 4 shy

(11) a common pathogenic organism in Mexico The agents

which affect intestinal mobility can cause the fluids to be

concentrated within the intestine in episodes of severe

diarrhea such as those caused by enterotoxigenic E coli

causing losses of fluid to be underestimated and subsequent

fluid replacement to be inadequate

Under the best of circumstances the clinical value of

these agents is moderate In controlled studies diphenoxylate

did not noticeably reduce the number nor the volume of

diarrheal stools or the amount of intravenous liquids required

by children with acute diarrhea (12 13)

In spite of these circumstances one pharmaceutical

company reported more than 25 million dollars in earnings from

the sale of Lomotil during 1983-1984 (17)

In the United States Lomotil carries a warning that it

is not a harmless drug and that the recommended dosage should

be strictly followed especially for children (9)

In the United Kingdom Lomotil has been reported as a

frequent cause of accidental poisoning through overdose in

children under five (17) Other studies indicate that small

children are highly susceptible to overdose (8) An overdose

of this medicine may cause severe respiratory depression that

can lead to a coma permanent cerebral damage or even death

Symptoms of overdose have been reported in children after only

one dose (18) After a concentrated campaign of public

awareness about this problem the company agreed to restrict

- 5 shy

the use of this product worldwide for children under two (19)

Nevertheless in many Latin American countries including

Mexico Lomotil is sold without prescription (20) Although

the fine print on the packages warns against its use in children

under six it has been verified that many mothers in our

country are unaware of these dangers

Some of the adverse reactions of Lomotil at recommended

doses include the following numbness of the limbs euphoria

depression general malaise lethargy confusion sedation

drowsiness restlessness severe headaches anaphylaxis

angioneui-otic oedema urticaria gingivitis pruritys toxic

megacolon paralytic ileus vomiting nausea anorexia

abdominal discomfort hyperthermia tachycardia urinary

retention and dryness of the skin and mucous membranes (9)

As with other medications various countries have placed

severe restrictions on its use while others have totally

eliminated it froin the market due to all of the above

mentioned side effects Australia has eliminated it from the

market (21) and the Philippines does not recommend its use

(1) However not all countries have placed restrictions on

these drugs yet

The 1984 publication of essential drugs of the Mexican

Health Sector includes diphenoxylate and atropine as

essential medicines under the heading antidiarrheals

indicating its use in cases of noninfectious diarrheas (20)

- 6 shy

II DRUGS WITH ANTISECRETORY PROPERTIES

Although many drugs have demonstrated an antisecretory

effect in experimental studies very few have been adequately

studied in clinical trials and virtually all of these have

shown serious side effects a low therapeutic effect andor

only modest efficacy For these reasons the Control of

Diarrheal Diseases Program of the World Health Organization

has clearly stated that none of these drugs can be recommended

for the treatment of acute infectious diarrhea in infants (3)

Bismuth subsalycilate in liquid form significantly

diminished the number of liquid stools as well as the

undesirable effects in young adults with travelers diarrhea

(22) but had no effect on the quantity of liquid in the

stools or the total weight of the stools implying that it had

no antisecretory effect It was also necessary to administer

a large volume (240-480 ml in less than four hours) and the

total dose of subsalycilate was too large to be practical or

safe in children

The effect of the doses of bismuth subsalycilate was

evaluated in a placebo-controlled double-blind test in

volunteers with acute diarrhea caused by enterotoxigenic

E coli This study showed no effect on the frequency or

the weight of stools (23)

Aspirin (25 mgskgday) was studied as an antisecretory

agent in a placebo-controlled double-blind test in

malnourished children with acute diarrhea after intravenous

-7shy

rehydration had been started The reduction in the daily

stool volume was statistically significant but the effective

change was only 100 ml per child which was not considered

clinically important (24)

Berberine an alcaloid used in some traditional remedies

for diarrhea has been shown to have an antisecretory effect

in animals However in two clinical trials in controlled

studies of adults with cholera or diarrhea with similar

characteristics there was no effect on the rate of stool

excretion nor was there a reduction in the rate to an extent

that could be considered clinically important (25 26)

III ACIDURIC BACTERIA

It has been recognized for a long time that the normal

aciduric bacteria in the human intestine inhibits the growth

of bacterial pathogens such as Salmonella and Shicrella Thus

it has been suggested that intestinal infections could be

treated or prevented by the ingestion of normal flora (27)

Lactobacillus acidophilus bifidobacterium and Streptococcus

faecalis are some of the frequently mentioned species The doubleshy

blind tests carried out with Streptococcus faecalis in adults

and children with acute diarrhea have reported a shortening in

length of the infection and the excretion of the pathogen

(28) Nevertheless controlled trials of the therapeutic and

prophylactic value of the Lactobacilli have not demonstrated

any benefits (29 30 31)

- 8shy

In a study carried out by students at the Universidad

Nacional Autonoma de Mexico (UNAM) it was observed that

medicines of this type were freely sold in Mexico and that

publicity for these agents widely promoted their use in infants

and children (20)

IV MEDICINES WITH ABSORPTIVE EFFECTS

Kaolin (generallly used in combination with pectin a

stabilizing agent) activiated charcoal and the clay attapulshy

gite have been proposed as antidiarrheal agents due to their

ability to collect and inactivate bacterial toxins However

clinical studies have offered little encouragement

A study published in the Journal of the American Medical

Association (11) of eighty children with acute diarrheal

illness in Guatemala tested the effectiveness of

antidiarrheal agents (a solution of kaolin and pectin and

one of liquid diphenoxilate with atropine) This study showed

that these medications were not useful in the treatment of

diarrhea specifically in acute infant diarrhea (11) They

increased the consistency of the stools but there were no

changes in the weight liquid content or the frequency of

stools

Despite its scientifically proven inefficacy kaolin and

pectin in a liquid suspension is included in the list of

essential drugs of the Mexican Health Sector (1984) and is

recommended for use in infants and preschool children under

the heading diarrhea The list states that there are no

contraindications precautions or pharmacological

- 9 shy

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

- 10 shy

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

CONTENTS

Pagre

2 I Medications Which Affect Intestinal Motility

7 II Drugs with Antisecretory Properties

8 III Aciduric Bacteria

9 IV Medicines With Absorptive Effects

Supplement Informal Survey of Medications for Diarrhea Sold in Pharmacies in Mexico City and Outskirts

References

Annex I Questionnaire for Mothers Who Will Buy Medications to Treat Infant Diarrhea in Different Pharmacies in Mexico City and Outskirts

Annex II List of Essential Drugs Mexican Health Sector (1984)

Annex III Sample Drug Advertising

Annex IV Basic Medications for Diarrhea in Mexico

The problem of infant diarrhea has been known in Mexico from

ancient times Historically children received innumerable

treatments in the form of home remedies varying from purgatives

to different teas made from special herbs with medicinal properties

(1)

In the era of modern medicine these home remedies have been

replaced by antibiotics and the so-called antidiarrheal agents

of which the following are notable for their frequent use

1 drugs which affect intestinal motility

2 drugs with antisecretory properties

3 and drugs which promote absorption

In spite of the great worldwide popularity of antibiotics and

antidiarrheals (2) this article will review the scientific

literature with respect to the inefficacy of these agents in the

treatment of acute infant diarrhea The concepts governing the

treatment of infant diarrhea are not applicable in all cases to the

management of travelers diarrhea

According to the World Health Organization (3) there are

three main types of diarrhea 1) acute watery diarrhea in which

the stools are white or liquid but not bloody 2) dysenteric

diarrhea in which the stools contain mucus and blood and 3)

chronic or persistent diarrhea which begins as an acute episode

but lasts longer than 21 days

The main complications of diarrhea are dehydration and tissue

catabolism which contribute to malnutrition and which can be

aggravated when food is withheld from children as part of the

treatment

-1ishy

Diarrheal therapy should be designed in a practical manner

for the prevention and correction of dehydration maintenance of

nutrition and treatment of dysentery

A vast number of treatments are commercially available today

the majority of which are sold widely throughout Mexico Selfshy

medication is so popular that the majority of the products are

sold without medical prescription in pharmacies dispensed on

occasion by people totally uninformed about the potential risks of

these products (20)

The majority of these medicines claim to reduce the volume of

stools and shorten the illness but none has proved to be safe and

sufficiently effective to be used regularly in young children

I MEDICATIONS WHICH AFFECT INTESTINAL MOBILITY

The opiates and their derivatives are widely used

antidiarrheal drugs which act primarily through their

antimotility properties Included are codeine tincture of

opium (all alkaloids) and diphenoxilate and loperamide (both

synthetic opium derivatives)

Loperamide is the most widely sold antidiarrheal drug in

the world having captured more than 10 of the world market

in 1983-1984 (4) More than a dozen pharmaceutical companies

produce drugs that ccntain loperamide

This drug acts on the muscles of the intestinal wall and

diminishes the movement of the intestinal contents in a

fashion similar to the opiates

According to Lancet only a few pediatric studies on

loperamide have been performed to date and none has shown

- 2 shy

that loperamide is effective In studies carried out in the

United Kingdom and in Libya loperamide did not reduce the

duration of the diarrhea or the length of hospital stay nor

did it improve weight gain in children up to four years old

who suffered from acute infectious diarrhea (5) Loperamide

is potentially harmful if used in the treatment of infectious

diarrhea caused by bacteria or amoebas because it can

prolong diarrhea and lead to a mistaken diagnosis of the

severity of the illness (6) In addition it can cause

perforation of the intestinal wall (7) In the United

Kingdom the manufacturer has admitted that the effectiveness

and safety of loperamide in acute infectious diarrhea has not

been proven (8)

Nevertheless this has not prevented some pharmaceutical

companies from manufacturing medicines containing loperamide

and advertising them without precautions or warnings in their

promotional messages

According to standards clearly set by the Control of

Diarrheal Disease Program of the World Health Organization

none of these medications is recommended for use in young

children due to the undesirable side effects they can cause

and the fact that the dangers are greater than the modest

benefit derived in the majority of cases (3) All can cause

nausea vomiting lethargy and paralytic ileus and can even

lead to cardiopulmonary arrest Tests with loperamide

(024 mgskgday) did not demonstrate any clinical effect of

statistical significance in the daily stool volume or of the

fluids required for rehydration in spite of the fact that the

duration of diarrhea was moderately diminished (14 15) One

larger -aily dose (048 mgskg) caused a modest although

statistically significant reduction in the length of the

diarrheal episode Nevertheless before the diarrhea stopped

the rate of stool fluid loss was not affected (16 3)

indicating that this drug has 1o antisecretory properties of

clinical benefit in watery diarrheas (2) Consequently

loperamide does not appear on the list of essential drugs of

World Health Organization

The American Medical Association advises against the use

of this drug in children under twelve and clearly lists as

possible side effects toxic megacolon and intestinal

perforation in acute infectious diarrhea In the United

States this medicine is sold only by prescription (9)

Due to all of these factors many developing countries

have placed regulations -o control or eliminate loperamideshy

containing medicines from their markets in recent years

For example Bangladesh decided to eliminate these from the

market after a thorough analysis of these drugs side effects

(10) The Philippines has recently decided to impose strong

restrictions on their use (10)

Another popular remedy medicines containing diphenoxylate

such as Lomotil (diphenoxilate with atropine sulfate) can

worsen the clinical course of infectious diarrheas

It has been clearly documented that the use of drugs with

diphenoxilate causes prolonged fever and difficulty in excretion

of the pathogenic agent in volunteers infected with Shigella

- 4 shy

(11) a common pathogenic organism in Mexico The agents

which affect intestinal mobility can cause the fluids to be

concentrated within the intestine in episodes of severe

diarrhea such as those caused by enterotoxigenic E coli

causing losses of fluid to be underestimated and subsequent

fluid replacement to be inadequate

Under the best of circumstances the clinical value of

these agents is moderate In controlled studies diphenoxylate

did not noticeably reduce the number nor the volume of

diarrheal stools or the amount of intravenous liquids required

by children with acute diarrhea (12 13)

In spite of these circumstances one pharmaceutical

company reported more than 25 million dollars in earnings from

the sale of Lomotil during 1983-1984 (17)

In the United States Lomotil carries a warning that it

is not a harmless drug and that the recommended dosage should

be strictly followed especially for children (9)

In the United Kingdom Lomotil has been reported as a

frequent cause of accidental poisoning through overdose in

children under five (17) Other studies indicate that small

children are highly susceptible to overdose (8) An overdose

of this medicine may cause severe respiratory depression that

can lead to a coma permanent cerebral damage or even death

Symptoms of overdose have been reported in children after only

one dose (18) After a concentrated campaign of public

awareness about this problem the company agreed to restrict

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the use of this product worldwide for children under two (19)

Nevertheless in many Latin American countries including

Mexico Lomotil is sold without prescription (20) Although

the fine print on the packages warns against its use in children

under six it has been verified that many mothers in our

country are unaware of these dangers

Some of the adverse reactions of Lomotil at recommended

doses include the following numbness of the limbs euphoria

depression general malaise lethargy confusion sedation

drowsiness restlessness severe headaches anaphylaxis

angioneui-otic oedema urticaria gingivitis pruritys toxic

megacolon paralytic ileus vomiting nausea anorexia

abdominal discomfort hyperthermia tachycardia urinary

retention and dryness of the skin and mucous membranes (9)

As with other medications various countries have placed

severe restrictions on its use while others have totally

eliminated it froin the market due to all of the above

mentioned side effects Australia has eliminated it from the

market (21) and the Philippines does not recommend its use

(1) However not all countries have placed restrictions on

these drugs yet

The 1984 publication of essential drugs of the Mexican

Health Sector includes diphenoxylate and atropine as

essential medicines under the heading antidiarrheals

indicating its use in cases of noninfectious diarrheas (20)

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II DRUGS WITH ANTISECRETORY PROPERTIES

Although many drugs have demonstrated an antisecretory

effect in experimental studies very few have been adequately

studied in clinical trials and virtually all of these have

shown serious side effects a low therapeutic effect andor

only modest efficacy For these reasons the Control of

Diarrheal Diseases Program of the World Health Organization

has clearly stated that none of these drugs can be recommended

for the treatment of acute infectious diarrhea in infants (3)

Bismuth subsalycilate in liquid form significantly

diminished the number of liquid stools as well as the

undesirable effects in young adults with travelers diarrhea

(22) but had no effect on the quantity of liquid in the

stools or the total weight of the stools implying that it had

no antisecretory effect It was also necessary to administer

a large volume (240-480 ml in less than four hours) and the

total dose of subsalycilate was too large to be practical or

safe in children

The effect of the doses of bismuth subsalycilate was

evaluated in a placebo-controlled double-blind test in

volunteers with acute diarrhea caused by enterotoxigenic

E coli This study showed no effect on the frequency or

the weight of stools (23)

Aspirin (25 mgskgday) was studied as an antisecretory

agent in a placebo-controlled double-blind test in

malnourished children with acute diarrhea after intravenous

-7shy

rehydration had been started The reduction in the daily

stool volume was statistically significant but the effective

change was only 100 ml per child which was not considered

clinically important (24)

Berberine an alcaloid used in some traditional remedies

for diarrhea has been shown to have an antisecretory effect

in animals However in two clinical trials in controlled

studies of adults with cholera or diarrhea with similar

characteristics there was no effect on the rate of stool

excretion nor was there a reduction in the rate to an extent

that could be considered clinically important (25 26)

III ACIDURIC BACTERIA

It has been recognized for a long time that the normal

aciduric bacteria in the human intestine inhibits the growth

of bacterial pathogens such as Salmonella and Shicrella Thus

it has been suggested that intestinal infections could be

treated or prevented by the ingestion of normal flora (27)

Lactobacillus acidophilus bifidobacterium and Streptococcus

faecalis are some of the frequently mentioned species The doubleshy

blind tests carried out with Streptococcus faecalis in adults

and children with acute diarrhea have reported a shortening in

length of the infection and the excretion of the pathogen

(28) Nevertheless controlled trials of the therapeutic and

prophylactic value of the Lactobacilli have not demonstrated

any benefits (29 30 31)

- 8shy

In a study carried out by students at the Universidad

Nacional Autonoma de Mexico (UNAM) it was observed that

medicines of this type were freely sold in Mexico and that

publicity for these agents widely promoted their use in infants

and children (20)

IV MEDICINES WITH ABSORPTIVE EFFECTS

Kaolin (generallly used in combination with pectin a

stabilizing agent) activiated charcoal and the clay attapulshy

gite have been proposed as antidiarrheal agents due to their

ability to collect and inactivate bacterial toxins However

clinical studies have offered little encouragement

A study published in the Journal of the American Medical

Association (11) of eighty children with acute diarrheal

illness in Guatemala tested the effectiveness of

antidiarrheal agents (a solution of kaolin and pectin and

one of liquid diphenoxilate with atropine) This study showed

that these medications were not useful in the treatment of

diarrhea specifically in acute infant diarrhea (11) They

increased the consistency of the stools but there were no

changes in the weight liquid content or the frequency of

stools

Despite its scientifically proven inefficacy kaolin and

pectin in a liquid suspension is included in the list of

essential drugs of the Mexican Health Sector (1984) and is

recommended for use in infants and preschool children under

the heading diarrhea The list states that there are no

contraindications precautions or pharmacological

- 9 shy

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

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SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

The problem of infant diarrhea has been known in Mexico from

ancient times Historically children received innumerable

treatments in the form of home remedies varying from purgatives

to different teas made from special herbs with medicinal properties

(1)

In the era of modern medicine these home remedies have been

replaced by antibiotics and the so-called antidiarrheal agents

of which the following are notable for their frequent use

1 drugs which affect intestinal motility

2 drugs with antisecretory properties

3 and drugs which promote absorption

In spite of the great worldwide popularity of antibiotics and

antidiarrheals (2) this article will review the scientific

literature with respect to the inefficacy of these agents in the

treatment of acute infant diarrhea The concepts governing the

treatment of infant diarrhea are not applicable in all cases to the

management of travelers diarrhea

According to the World Health Organization (3) there are

three main types of diarrhea 1) acute watery diarrhea in which

the stools are white or liquid but not bloody 2) dysenteric

diarrhea in which the stools contain mucus and blood and 3)

chronic or persistent diarrhea which begins as an acute episode

but lasts longer than 21 days

The main complications of diarrhea are dehydration and tissue

catabolism which contribute to malnutrition and which can be

aggravated when food is withheld from children as part of the

treatment

-1ishy

Diarrheal therapy should be designed in a practical manner

for the prevention and correction of dehydration maintenance of

nutrition and treatment of dysentery

A vast number of treatments are commercially available today

the majority of which are sold widely throughout Mexico Selfshy

medication is so popular that the majority of the products are

sold without medical prescription in pharmacies dispensed on

occasion by people totally uninformed about the potential risks of

these products (20)

The majority of these medicines claim to reduce the volume of

stools and shorten the illness but none has proved to be safe and

sufficiently effective to be used regularly in young children

I MEDICATIONS WHICH AFFECT INTESTINAL MOBILITY

The opiates and their derivatives are widely used

antidiarrheal drugs which act primarily through their

antimotility properties Included are codeine tincture of

opium (all alkaloids) and diphenoxilate and loperamide (both

synthetic opium derivatives)

Loperamide is the most widely sold antidiarrheal drug in

the world having captured more than 10 of the world market

in 1983-1984 (4) More than a dozen pharmaceutical companies

produce drugs that ccntain loperamide

This drug acts on the muscles of the intestinal wall and

diminishes the movement of the intestinal contents in a

fashion similar to the opiates

According to Lancet only a few pediatric studies on

loperamide have been performed to date and none has shown

- 2 shy

that loperamide is effective In studies carried out in the

United Kingdom and in Libya loperamide did not reduce the

duration of the diarrhea or the length of hospital stay nor

did it improve weight gain in children up to four years old

who suffered from acute infectious diarrhea (5) Loperamide

is potentially harmful if used in the treatment of infectious

diarrhea caused by bacteria or amoebas because it can

prolong diarrhea and lead to a mistaken diagnosis of the

severity of the illness (6) In addition it can cause

perforation of the intestinal wall (7) In the United

Kingdom the manufacturer has admitted that the effectiveness

and safety of loperamide in acute infectious diarrhea has not

been proven (8)

Nevertheless this has not prevented some pharmaceutical

companies from manufacturing medicines containing loperamide

and advertising them without precautions or warnings in their

promotional messages

According to standards clearly set by the Control of

Diarrheal Disease Program of the World Health Organization

none of these medications is recommended for use in young

children due to the undesirable side effects they can cause

and the fact that the dangers are greater than the modest

benefit derived in the majority of cases (3) All can cause

nausea vomiting lethargy and paralytic ileus and can even

lead to cardiopulmonary arrest Tests with loperamide

(024 mgskgday) did not demonstrate any clinical effect of

statistical significance in the daily stool volume or of the

fluids required for rehydration in spite of the fact that the

duration of diarrhea was moderately diminished (14 15) One

larger -aily dose (048 mgskg) caused a modest although

statistically significant reduction in the length of the

diarrheal episode Nevertheless before the diarrhea stopped

the rate of stool fluid loss was not affected (16 3)

indicating that this drug has 1o antisecretory properties of

clinical benefit in watery diarrheas (2) Consequently

loperamide does not appear on the list of essential drugs of

World Health Organization

The American Medical Association advises against the use

of this drug in children under twelve and clearly lists as

possible side effects toxic megacolon and intestinal

perforation in acute infectious diarrhea In the United

States this medicine is sold only by prescription (9)

Due to all of these factors many developing countries

have placed regulations -o control or eliminate loperamideshy

containing medicines from their markets in recent years

For example Bangladesh decided to eliminate these from the

market after a thorough analysis of these drugs side effects

(10) The Philippines has recently decided to impose strong

restrictions on their use (10)

Another popular remedy medicines containing diphenoxylate

such as Lomotil (diphenoxilate with atropine sulfate) can

worsen the clinical course of infectious diarrheas

It has been clearly documented that the use of drugs with

diphenoxilate causes prolonged fever and difficulty in excretion

of the pathogenic agent in volunteers infected with Shigella

- 4 shy

(11) a common pathogenic organism in Mexico The agents

which affect intestinal mobility can cause the fluids to be

concentrated within the intestine in episodes of severe

diarrhea such as those caused by enterotoxigenic E coli

causing losses of fluid to be underestimated and subsequent

fluid replacement to be inadequate

Under the best of circumstances the clinical value of

these agents is moderate In controlled studies diphenoxylate

did not noticeably reduce the number nor the volume of

diarrheal stools or the amount of intravenous liquids required

by children with acute diarrhea (12 13)

In spite of these circumstances one pharmaceutical

company reported more than 25 million dollars in earnings from

the sale of Lomotil during 1983-1984 (17)

In the United States Lomotil carries a warning that it

is not a harmless drug and that the recommended dosage should

be strictly followed especially for children (9)

In the United Kingdom Lomotil has been reported as a

frequent cause of accidental poisoning through overdose in

children under five (17) Other studies indicate that small

children are highly susceptible to overdose (8) An overdose

of this medicine may cause severe respiratory depression that

can lead to a coma permanent cerebral damage or even death

Symptoms of overdose have been reported in children after only

one dose (18) After a concentrated campaign of public

awareness about this problem the company agreed to restrict

- 5 shy

the use of this product worldwide for children under two (19)

Nevertheless in many Latin American countries including

Mexico Lomotil is sold without prescription (20) Although

the fine print on the packages warns against its use in children

under six it has been verified that many mothers in our

country are unaware of these dangers

Some of the adverse reactions of Lomotil at recommended

doses include the following numbness of the limbs euphoria

depression general malaise lethargy confusion sedation

drowsiness restlessness severe headaches anaphylaxis

angioneui-otic oedema urticaria gingivitis pruritys toxic

megacolon paralytic ileus vomiting nausea anorexia

abdominal discomfort hyperthermia tachycardia urinary

retention and dryness of the skin and mucous membranes (9)

As with other medications various countries have placed

severe restrictions on its use while others have totally

eliminated it froin the market due to all of the above

mentioned side effects Australia has eliminated it from the

market (21) and the Philippines does not recommend its use

(1) However not all countries have placed restrictions on

these drugs yet

The 1984 publication of essential drugs of the Mexican

Health Sector includes diphenoxylate and atropine as

essential medicines under the heading antidiarrheals

indicating its use in cases of noninfectious diarrheas (20)

- 6 shy

II DRUGS WITH ANTISECRETORY PROPERTIES

Although many drugs have demonstrated an antisecretory

effect in experimental studies very few have been adequately

studied in clinical trials and virtually all of these have

shown serious side effects a low therapeutic effect andor

only modest efficacy For these reasons the Control of

Diarrheal Diseases Program of the World Health Organization

has clearly stated that none of these drugs can be recommended

for the treatment of acute infectious diarrhea in infants (3)

Bismuth subsalycilate in liquid form significantly

diminished the number of liquid stools as well as the

undesirable effects in young adults with travelers diarrhea

(22) but had no effect on the quantity of liquid in the

stools or the total weight of the stools implying that it had

no antisecretory effect It was also necessary to administer

a large volume (240-480 ml in less than four hours) and the

total dose of subsalycilate was too large to be practical or

safe in children

The effect of the doses of bismuth subsalycilate was

evaluated in a placebo-controlled double-blind test in

volunteers with acute diarrhea caused by enterotoxigenic

E coli This study showed no effect on the frequency or

the weight of stools (23)

Aspirin (25 mgskgday) was studied as an antisecretory

agent in a placebo-controlled double-blind test in

malnourished children with acute diarrhea after intravenous

-7shy

rehydration had been started The reduction in the daily

stool volume was statistically significant but the effective

change was only 100 ml per child which was not considered

clinically important (24)

Berberine an alcaloid used in some traditional remedies

for diarrhea has been shown to have an antisecretory effect

in animals However in two clinical trials in controlled

studies of adults with cholera or diarrhea with similar

characteristics there was no effect on the rate of stool

excretion nor was there a reduction in the rate to an extent

that could be considered clinically important (25 26)

III ACIDURIC BACTERIA

It has been recognized for a long time that the normal

aciduric bacteria in the human intestine inhibits the growth

of bacterial pathogens such as Salmonella and Shicrella Thus

it has been suggested that intestinal infections could be

treated or prevented by the ingestion of normal flora (27)

Lactobacillus acidophilus bifidobacterium and Streptococcus

faecalis are some of the frequently mentioned species The doubleshy

blind tests carried out with Streptococcus faecalis in adults

and children with acute diarrhea have reported a shortening in

length of the infection and the excretion of the pathogen

(28) Nevertheless controlled trials of the therapeutic and

prophylactic value of the Lactobacilli have not demonstrated

any benefits (29 30 31)

- 8shy

In a study carried out by students at the Universidad

Nacional Autonoma de Mexico (UNAM) it was observed that

medicines of this type were freely sold in Mexico and that

publicity for these agents widely promoted their use in infants

and children (20)

IV MEDICINES WITH ABSORPTIVE EFFECTS

Kaolin (generallly used in combination with pectin a

stabilizing agent) activiated charcoal and the clay attapulshy

gite have been proposed as antidiarrheal agents due to their

ability to collect and inactivate bacterial toxins However

clinical studies have offered little encouragement

A study published in the Journal of the American Medical

Association (11) of eighty children with acute diarrheal

illness in Guatemala tested the effectiveness of

antidiarrheal agents (a solution of kaolin and pectin and

one of liquid diphenoxilate with atropine) This study showed

that these medications were not useful in the treatment of

diarrhea specifically in acute infant diarrhea (11) They

increased the consistency of the stools but there were no

changes in the weight liquid content or the frequency of

stools

Despite its scientifically proven inefficacy kaolin and

pectin in a liquid suspension is included in the list of

essential drugs of the Mexican Health Sector (1984) and is

recommended for use in infants and preschool children under

the heading diarrhea The list states that there are no

contraindications precautions or pharmacological

- 9 shy

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

- 10 shy

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

Diarrheal therapy should be designed in a practical manner

for the prevention and correction of dehydration maintenance of

nutrition and treatment of dysentery

A vast number of treatments are commercially available today

the majority of which are sold widely throughout Mexico Selfshy

medication is so popular that the majority of the products are

sold without medical prescription in pharmacies dispensed on

occasion by people totally uninformed about the potential risks of

these products (20)

The majority of these medicines claim to reduce the volume of

stools and shorten the illness but none has proved to be safe and

sufficiently effective to be used regularly in young children

I MEDICATIONS WHICH AFFECT INTESTINAL MOBILITY

The opiates and their derivatives are widely used

antidiarrheal drugs which act primarily through their

antimotility properties Included are codeine tincture of

opium (all alkaloids) and diphenoxilate and loperamide (both

synthetic opium derivatives)

Loperamide is the most widely sold antidiarrheal drug in

the world having captured more than 10 of the world market

in 1983-1984 (4) More than a dozen pharmaceutical companies

produce drugs that ccntain loperamide

This drug acts on the muscles of the intestinal wall and

diminishes the movement of the intestinal contents in a

fashion similar to the opiates

According to Lancet only a few pediatric studies on

loperamide have been performed to date and none has shown

- 2 shy

that loperamide is effective In studies carried out in the

United Kingdom and in Libya loperamide did not reduce the

duration of the diarrhea or the length of hospital stay nor

did it improve weight gain in children up to four years old

who suffered from acute infectious diarrhea (5) Loperamide

is potentially harmful if used in the treatment of infectious

diarrhea caused by bacteria or amoebas because it can

prolong diarrhea and lead to a mistaken diagnosis of the

severity of the illness (6) In addition it can cause

perforation of the intestinal wall (7) In the United

Kingdom the manufacturer has admitted that the effectiveness

and safety of loperamide in acute infectious diarrhea has not

been proven (8)

Nevertheless this has not prevented some pharmaceutical

companies from manufacturing medicines containing loperamide

and advertising them without precautions or warnings in their

promotional messages

According to standards clearly set by the Control of

Diarrheal Disease Program of the World Health Organization

none of these medications is recommended for use in young

children due to the undesirable side effects they can cause

and the fact that the dangers are greater than the modest

benefit derived in the majority of cases (3) All can cause

nausea vomiting lethargy and paralytic ileus and can even

lead to cardiopulmonary arrest Tests with loperamide

(024 mgskgday) did not demonstrate any clinical effect of

statistical significance in the daily stool volume or of the

fluids required for rehydration in spite of the fact that the

duration of diarrhea was moderately diminished (14 15) One

larger -aily dose (048 mgskg) caused a modest although

statistically significant reduction in the length of the

diarrheal episode Nevertheless before the diarrhea stopped

the rate of stool fluid loss was not affected (16 3)

indicating that this drug has 1o antisecretory properties of

clinical benefit in watery diarrheas (2) Consequently

loperamide does not appear on the list of essential drugs of

World Health Organization

The American Medical Association advises against the use

of this drug in children under twelve and clearly lists as

possible side effects toxic megacolon and intestinal

perforation in acute infectious diarrhea In the United

States this medicine is sold only by prescription (9)

Due to all of these factors many developing countries

have placed regulations -o control or eliminate loperamideshy

containing medicines from their markets in recent years

For example Bangladesh decided to eliminate these from the

market after a thorough analysis of these drugs side effects

(10) The Philippines has recently decided to impose strong

restrictions on their use (10)

Another popular remedy medicines containing diphenoxylate

such as Lomotil (diphenoxilate with atropine sulfate) can

worsen the clinical course of infectious diarrheas

It has been clearly documented that the use of drugs with

diphenoxilate causes prolonged fever and difficulty in excretion

of the pathogenic agent in volunteers infected with Shigella

- 4 shy

(11) a common pathogenic organism in Mexico The agents

which affect intestinal mobility can cause the fluids to be

concentrated within the intestine in episodes of severe

diarrhea such as those caused by enterotoxigenic E coli

causing losses of fluid to be underestimated and subsequent

fluid replacement to be inadequate

Under the best of circumstances the clinical value of

these agents is moderate In controlled studies diphenoxylate

did not noticeably reduce the number nor the volume of

diarrheal stools or the amount of intravenous liquids required

by children with acute diarrhea (12 13)

In spite of these circumstances one pharmaceutical

company reported more than 25 million dollars in earnings from

the sale of Lomotil during 1983-1984 (17)

In the United States Lomotil carries a warning that it

is not a harmless drug and that the recommended dosage should

be strictly followed especially for children (9)

In the United Kingdom Lomotil has been reported as a

frequent cause of accidental poisoning through overdose in

children under five (17) Other studies indicate that small

children are highly susceptible to overdose (8) An overdose

of this medicine may cause severe respiratory depression that

can lead to a coma permanent cerebral damage or even death

Symptoms of overdose have been reported in children after only

one dose (18) After a concentrated campaign of public

awareness about this problem the company agreed to restrict

- 5 shy

the use of this product worldwide for children under two (19)

Nevertheless in many Latin American countries including

Mexico Lomotil is sold without prescription (20) Although

the fine print on the packages warns against its use in children

under six it has been verified that many mothers in our

country are unaware of these dangers

Some of the adverse reactions of Lomotil at recommended

doses include the following numbness of the limbs euphoria

depression general malaise lethargy confusion sedation

drowsiness restlessness severe headaches anaphylaxis

angioneui-otic oedema urticaria gingivitis pruritys toxic

megacolon paralytic ileus vomiting nausea anorexia

abdominal discomfort hyperthermia tachycardia urinary

retention and dryness of the skin and mucous membranes (9)

As with other medications various countries have placed

severe restrictions on its use while others have totally

eliminated it froin the market due to all of the above

mentioned side effects Australia has eliminated it from the

market (21) and the Philippines does not recommend its use

(1) However not all countries have placed restrictions on

these drugs yet

The 1984 publication of essential drugs of the Mexican

Health Sector includes diphenoxylate and atropine as

essential medicines under the heading antidiarrheals

indicating its use in cases of noninfectious diarrheas (20)

- 6 shy

II DRUGS WITH ANTISECRETORY PROPERTIES

Although many drugs have demonstrated an antisecretory

effect in experimental studies very few have been adequately

studied in clinical trials and virtually all of these have

shown serious side effects a low therapeutic effect andor

only modest efficacy For these reasons the Control of

Diarrheal Diseases Program of the World Health Organization

has clearly stated that none of these drugs can be recommended

for the treatment of acute infectious diarrhea in infants (3)

Bismuth subsalycilate in liquid form significantly

diminished the number of liquid stools as well as the

undesirable effects in young adults with travelers diarrhea

(22) but had no effect on the quantity of liquid in the

stools or the total weight of the stools implying that it had

no antisecretory effect It was also necessary to administer

a large volume (240-480 ml in less than four hours) and the

total dose of subsalycilate was too large to be practical or

safe in children

The effect of the doses of bismuth subsalycilate was

evaluated in a placebo-controlled double-blind test in

volunteers with acute diarrhea caused by enterotoxigenic

E coli This study showed no effect on the frequency or

the weight of stools (23)

Aspirin (25 mgskgday) was studied as an antisecretory

agent in a placebo-controlled double-blind test in

malnourished children with acute diarrhea after intravenous

-7shy

rehydration had been started The reduction in the daily

stool volume was statistically significant but the effective

change was only 100 ml per child which was not considered

clinically important (24)

Berberine an alcaloid used in some traditional remedies

for diarrhea has been shown to have an antisecretory effect

in animals However in two clinical trials in controlled

studies of adults with cholera or diarrhea with similar

characteristics there was no effect on the rate of stool

excretion nor was there a reduction in the rate to an extent

that could be considered clinically important (25 26)

III ACIDURIC BACTERIA

It has been recognized for a long time that the normal

aciduric bacteria in the human intestine inhibits the growth

of bacterial pathogens such as Salmonella and Shicrella Thus

it has been suggested that intestinal infections could be

treated or prevented by the ingestion of normal flora (27)

Lactobacillus acidophilus bifidobacterium and Streptococcus

faecalis are some of the frequently mentioned species The doubleshy

blind tests carried out with Streptococcus faecalis in adults

and children with acute diarrhea have reported a shortening in

length of the infection and the excretion of the pathogen

(28) Nevertheless controlled trials of the therapeutic and

prophylactic value of the Lactobacilli have not demonstrated

any benefits (29 30 31)

- 8shy

In a study carried out by students at the Universidad

Nacional Autonoma de Mexico (UNAM) it was observed that

medicines of this type were freely sold in Mexico and that

publicity for these agents widely promoted their use in infants

and children (20)

IV MEDICINES WITH ABSORPTIVE EFFECTS

Kaolin (generallly used in combination with pectin a

stabilizing agent) activiated charcoal and the clay attapulshy

gite have been proposed as antidiarrheal agents due to their

ability to collect and inactivate bacterial toxins However

clinical studies have offered little encouragement

A study published in the Journal of the American Medical

Association (11) of eighty children with acute diarrheal

illness in Guatemala tested the effectiveness of

antidiarrheal agents (a solution of kaolin and pectin and

one of liquid diphenoxilate with atropine) This study showed

that these medications were not useful in the treatment of

diarrhea specifically in acute infant diarrhea (11) They

increased the consistency of the stools but there were no

changes in the weight liquid content or the frequency of

stools

Despite its scientifically proven inefficacy kaolin and

pectin in a liquid suspension is included in the list of

essential drugs of the Mexican Health Sector (1984) and is

recommended for use in infants and preschool children under

the heading diarrhea The list states that there are no

contraindications precautions or pharmacological

- 9 shy

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

- 10 shy

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

that loperamide is effective In studies carried out in the

United Kingdom and in Libya loperamide did not reduce the

duration of the diarrhea or the length of hospital stay nor

did it improve weight gain in children up to four years old

who suffered from acute infectious diarrhea (5) Loperamide

is potentially harmful if used in the treatment of infectious

diarrhea caused by bacteria or amoebas because it can

prolong diarrhea and lead to a mistaken diagnosis of the

severity of the illness (6) In addition it can cause

perforation of the intestinal wall (7) In the United

Kingdom the manufacturer has admitted that the effectiveness

and safety of loperamide in acute infectious diarrhea has not

been proven (8)

Nevertheless this has not prevented some pharmaceutical

companies from manufacturing medicines containing loperamide

and advertising them without precautions or warnings in their

promotional messages

According to standards clearly set by the Control of

Diarrheal Disease Program of the World Health Organization

none of these medications is recommended for use in young

children due to the undesirable side effects they can cause

and the fact that the dangers are greater than the modest

benefit derived in the majority of cases (3) All can cause

nausea vomiting lethargy and paralytic ileus and can even

lead to cardiopulmonary arrest Tests with loperamide

(024 mgskgday) did not demonstrate any clinical effect of

statistical significance in the daily stool volume or of the

fluids required for rehydration in spite of the fact that the

duration of diarrhea was moderately diminished (14 15) One

larger -aily dose (048 mgskg) caused a modest although

statistically significant reduction in the length of the

diarrheal episode Nevertheless before the diarrhea stopped

the rate of stool fluid loss was not affected (16 3)

indicating that this drug has 1o antisecretory properties of

clinical benefit in watery diarrheas (2) Consequently

loperamide does not appear on the list of essential drugs of

World Health Organization

The American Medical Association advises against the use

of this drug in children under twelve and clearly lists as

possible side effects toxic megacolon and intestinal

perforation in acute infectious diarrhea In the United

States this medicine is sold only by prescription (9)

Due to all of these factors many developing countries

have placed regulations -o control or eliminate loperamideshy

containing medicines from their markets in recent years

For example Bangladesh decided to eliminate these from the

market after a thorough analysis of these drugs side effects

(10) The Philippines has recently decided to impose strong

restrictions on their use (10)

Another popular remedy medicines containing diphenoxylate

such as Lomotil (diphenoxilate with atropine sulfate) can

worsen the clinical course of infectious diarrheas

It has been clearly documented that the use of drugs with

diphenoxilate causes prolonged fever and difficulty in excretion

of the pathogenic agent in volunteers infected with Shigella

- 4 shy

(11) a common pathogenic organism in Mexico The agents

which affect intestinal mobility can cause the fluids to be

concentrated within the intestine in episodes of severe

diarrhea such as those caused by enterotoxigenic E coli

causing losses of fluid to be underestimated and subsequent

fluid replacement to be inadequate

Under the best of circumstances the clinical value of

these agents is moderate In controlled studies diphenoxylate

did not noticeably reduce the number nor the volume of

diarrheal stools or the amount of intravenous liquids required

by children with acute diarrhea (12 13)

In spite of these circumstances one pharmaceutical

company reported more than 25 million dollars in earnings from

the sale of Lomotil during 1983-1984 (17)

In the United States Lomotil carries a warning that it

is not a harmless drug and that the recommended dosage should

be strictly followed especially for children (9)

In the United Kingdom Lomotil has been reported as a

frequent cause of accidental poisoning through overdose in

children under five (17) Other studies indicate that small

children are highly susceptible to overdose (8) An overdose

of this medicine may cause severe respiratory depression that

can lead to a coma permanent cerebral damage or even death

Symptoms of overdose have been reported in children after only

one dose (18) After a concentrated campaign of public

awareness about this problem the company agreed to restrict

- 5 shy

the use of this product worldwide for children under two (19)

Nevertheless in many Latin American countries including

Mexico Lomotil is sold without prescription (20) Although

the fine print on the packages warns against its use in children

under six it has been verified that many mothers in our

country are unaware of these dangers

Some of the adverse reactions of Lomotil at recommended

doses include the following numbness of the limbs euphoria

depression general malaise lethargy confusion sedation

drowsiness restlessness severe headaches anaphylaxis

angioneui-otic oedema urticaria gingivitis pruritys toxic

megacolon paralytic ileus vomiting nausea anorexia

abdominal discomfort hyperthermia tachycardia urinary

retention and dryness of the skin and mucous membranes (9)

As with other medications various countries have placed

severe restrictions on its use while others have totally

eliminated it froin the market due to all of the above

mentioned side effects Australia has eliminated it from the

market (21) and the Philippines does not recommend its use

(1) However not all countries have placed restrictions on

these drugs yet

The 1984 publication of essential drugs of the Mexican

Health Sector includes diphenoxylate and atropine as

essential medicines under the heading antidiarrheals

indicating its use in cases of noninfectious diarrheas (20)

- 6 shy

II DRUGS WITH ANTISECRETORY PROPERTIES

Although many drugs have demonstrated an antisecretory

effect in experimental studies very few have been adequately

studied in clinical trials and virtually all of these have

shown serious side effects a low therapeutic effect andor

only modest efficacy For these reasons the Control of

Diarrheal Diseases Program of the World Health Organization

has clearly stated that none of these drugs can be recommended

for the treatment of acute infectious diarrhea in infants (3)

Bismuth subsalycilate in liquid form significantly

diminished the number of liquid stools as well as the

undesirable effects in young adults with travelers diarrhea

(22) but had no effect on the quantity of liquid in the

stools or the total weight of the stools implying that it had

no antisecretory effect It was also necessary to administer

a large volume (240-480 ml in less than four hours) and the

total dose of subsalycilate was too large to be practical or

safe in children

The effect of the doses of bismuth subsalycilate was

evaluated in a placebo-controlled double-blind test in

volunteers with acute diarrhea caused by enterotoxigenic

E coli This study showed no effect on the frequency or

the weight of stools (23)

Aspirin (25 mgskgday) was studied as an antisecretory

agent in a placebo-controlled double-blind test in

malnourished children with acute diarrhea after intravenous

-7shy

rehydration had been started The reduction in the daily

stool volume was statistically significant but the effective

change was only 100 ml per child which was not considered

clinically important (24)

Berberine an alcaloid used in some traditional remedies

for diarrhea has been shown to have an antisecretory effect

in animals However in two clinical trials in controlled

studies of adults with cholera or diarrhea with similar

characteristics there was no effect on the rate of stool

excretion nor was there a reduction in the rate to an extent

that could be considered clinically important (25 26)

III ACIDURIC BACTERIA

It has been recognized for a long time that the normal

aciduric bacteria in the human intestine inhibits the growth

of bacterial pathogens such as Salmonella and Shicrella Thus

it has been suggested that intestinal infections could be

treated or prevented by the ingestion of normal flora (27)

Lactobacillus acidophilus bifidobacterium and Streptococcus

faecalis are some of the frequently mentioned species The doubleshy

blind tests carried out with Streptococcus faecalis in adults

and children with acute diarrhea have reported a shortening in

length of the infection and the excretion of the pathogen

(28) Nevertheless controlled trials of the therapeutic and

prophylactic value of the Lactobacilli have not demonstrated

any benefits (29 30 31)

- 8shy

In a study carried out by students at the Universidad

Nacional Autonoma de Mexico (UNAM) it was observed that

medicines of this type were freely sold in Mexico and that

publicity for these agents widely promoted their use in infants

and children (20)

IV MEDICINES WITH ABSORPTIVE EFFECTS

Kaolin (generallly used in combination with pectin a

stabilizing agent) activiated charcoal and the clay attapulshy

gite have been proposed as antidiarrheal agents due to their

ability to collect and inactivate bacterial toxins However

clinical studies have offered little encouragement

A study published in the Journal of the American Medical

Association (11) of eighty children with acute diarrheal

illness in Guatemala tested the effectiveness of

antidiarrheal agents (a solution of kaolin and pectin and

one of liquid diphenoxilate with atropine) This study showed

that these medications were not useful in the treatment of

diarrhea specifically in acute infant diarrhea (11) They

increased the consistency of the stools but there were no

changes in the weight liquid content or the frequency of

stools

Despite its scientifically proven inefficacy kaolin and

pectin in a liquid suspension is included in the list of

essential drugs of the Mexican Health Sector (1984) and is

recommended for use in infants and preschool children under

the heading diarrhea The list states that there are no

contraindications precautions or pharmacological

- 9 shy

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

- 10 shy

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

fluids required for rehydration in spite of the fact that the

duration of diarrhea was moderately diminished (14 15) One

larger -aily dose (048 mgskg) caused a modest although

statistically significant reduction in the length of the

diarrheal episode Nevertheless before the diarrhea stopped

the rate of stool fluid loss was not affected (16 3)

indicating that this drug has 1o antisecretory properties of

clinical benefit in watery diarrheas (2) Consequently

loperamide does not appear on the list of essential drugs of

World Health Organization

The American Medical Association advises against the use

of this drug in children under twelve and clearly lists as

possible side effects toxic megacolon and intestinal

perforation in acute infectious diarrhea In the United

States this medicine is sold only by prescription (9)

Due to all of these factors many developing countries

have placed regulations -o control or eliminate loperamideshy

containing medicines from their markets in recent years

For example Bangladesh decided to eliminate these from the

market after a thorough analysis of these drugs side effects

(10) The Philippines has recently decided to impose strong

restrictions on their use (10)

Another popular remedy medicines containing diphenoxylate

such as Lomotil (diphenoxilate with atropine sulfate) can

worsen the clinical course of infectious diarrheas

It has been clearly documented that the use of drugs with

diphenoxilate causes prolonged fever and difficulty in excretion

of the pathogenic agent in volunteers infected with Shigella

- 4 shy

(11) a common pathogenic organism in Mexico The agents

which affect intestinal mobility can cause the fluids to be

concentrated within the intestine in episodes of severe

diarrhea such as those caused by enterotoxigenic E coli

causing losses of fluid to be underestimated and subsequent

fluid replacement to be inadequate

Under the best of circumstances the clinical value of

these agents is moderate In controlled studies diphenoxylate

did not noticeably reduce the number nor the volume of

diarrheal stools or the amount of intravenous liquids required

by children with acute diarrhea (12 13)

In spite of these circumstances one pharmaceutical

company reported more than 25 million dollars in earnings from

the sale of Lomotil during 1983-1984 (17)

In the United States Lomotil carries a warning that it

is not a harmless drug and that the recommended dosage should

be strictly followed especially for children (9)

In the United Kingdom Lomotil has been reported as a

frequent cause of accidental poisoning through overdose in

children under five (17) Other studies indicate that small

children are highly susceptible to overdose (8) An overdose

of this medicine may cause severe respiratory depression that

can lead to a coma permanent cerebral damage or even death

Symptoms of overdose have been reported in children after only

one dose (18) After a concentrated campaign of public

awareness about this problem the company agreed to restrict

- 5 shy

the use of this product worldwide for children under two (19)

Nevertheless in many Latin American countries including

Mexico Lomotil is sold without prescription (20) Although

the fine print on the packages warns against its use in children

under six it has been verified that many mothers in our

country are unaware of these dangers

Some of the adverse reactions of Lomotil at recommended

doses include the following numbness of the limbs euphoria

depression general malaise lethargy confusion sedation

drowsiness restlessness severe headaches anaphylaxis

angioneui-otic oedema urticaria gingivitis pruritys toxic

megacolon paralytic ileus vomiting nausea anorexia

abdominal discomfort hyperthermia tachycardia urinary

retention and dryness of the skin and mucous membranes (9)

As with other medications various countries have placed

severe restrictions on its use while others have totally

eliminated it froin the market due to all of the above

mentioned side effects Australia has eliminated it from the

market (21) and the Philippines does not recommend its use

(1) However not all countries have placed restrictions on

these drugs yet

The 1984 publication of essential drugs of the Mexican

Health Sector includes diphenoxylate and atropine as

essential medicines under the heading antidiarrheals

indicating its use in cases of noninfectious diarrheas (20)

- 6 shy

II DRUGS WITH ANTISECRETORY PROPERTIES

Although many drugs have demonstrated an antisecretory

effect in experimental studies very few have been adequately

studied in clinical trials and virtually all of these have

shown serious side effects a low therapeutic effect andor

only modest efficacy For these reasons the Control of

Diarrheal Diseases Program of the World Health Organization

has clearly stated that none of these drugs can be recommended

for the treatment of acute infectious diarrhea in infants (3)

Bismuth subsalycilate in liquid form significantly

diminished the number of liquid stools as well as the

undesirable effects in young adults with travelers diarrhea

(22) but had no effect on the quantity of liquid in the

stools or the total weight of the stools implying that it had

no antisecretory effect It was also necessary to administer

a large volume (240-480 ml in less than four hours) and the

total dose of subsalycilate was too large to be practical or

safe in children

The effect of the doses of bismuth subsalycilate was

evaluated in a placebo-controlled double-blind test in

volunteers with acute diarrhea caused by enterotoxigenic

E coli This study showed no effect on the frequency or

the weight of stools (23)

Aspirin (25 mgskgday) was studied as an antisecretory

agent in a placebo-controlled double-blind test in

malnourished children with acute diarrhea after intravenous

-7shy

rehydration had been started The reduction in the daily

stool volume was statistically significant but the effective

change was only 100 ml per child which was not considered

clinically important (24)

Berberine an alcaloid used in some traditional remedies

for diarrhea has been shown to have an antisecretory effect

in animals However in two clinical trials in controlled

studies of adults with cholera or diarrhea with similar

characteristics there was no effect on the rate of stool

excretion nor was there a reduction in the rate to an extent

that could be considered clinically important (25 26)

III ACIDURIC BACTERIA

It has been recognized for a long time that the normal

aciduric bacteria in the human intestine inhibits the growth

of bacterial pathogens such as Salmonella and Shicrella Thus

it has been suggested that intestinal infections could be

treated or prevented by the ingestion of normal flora (27)

Lactobacillus acidophilus bifidobacterium and Streptococcus

faecalis are some of the frequently mentioned species The doubleshy

blind tests carried out with Streptococcus faecalis in adults

and children with acute diarrhea have reported a shortening in

length of the infection and the excretion of the pathogen

(28) Nevertheless controlled trials of the therapeutic and

prophylactic value of the Lactobacilli have not demonstrated

any benefits (29 30 31)

- 8shy

In a study carried out by students at the Universidad

Nacional Autonoma de Mexico (UNAM) it was observed that

medicines of this type were freely sold in Mexico and that

publicity for these agents widely promoted their use in infants

and children (20)

IV MEDICINES WITH ABSORPTIVE EFFECTS

Kaolin (generallly used in combination with pectin a

stabilizing agent) activiated charcoal and the clay attapulshy

gite have been proposed as antidiarrheal agents due to their

ability to collect and inactivate bacterial toxins However

clinical studies have offered little encouragement

A study published in the Journal of the American Medical

Association (11) of eighty children with acute diarrheal

illness in Guatemala tested the effectiveness of

antidiarrheal agents (a solution of kaolin and pectin and

one of liquid diphenoxilate with atropine) This study showed

that these medications were not useful in the treatment of

diarrhea specifically in acute infant diarrhea (11) They

increased the consistency of the stools but there were no

changes in the weight liquid content or the frequency of

stools

Despite its scientifically proven inefficacy kaolin and

pectin in a liquid suspension is included in the list of

essential drugs of the Mexican Health Sector (1984) and is

recommended for use in infants and preschool children under

the heading diarrhea The list states that there are no

contraindications precautions or pharmacological

- 9 shy

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

- 10 shy

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

(11) a common pathogenic organism in Mexico The agents

which affect intestinal mobility can cause the fluids to be

concentrated within the intestine in episodes of severe

diarrhea such as those caused by enterotoxigenic E coli

causing losses of fluid to be underestimated and subsequent

fluid replacement to be inadequate

Under the best of circumstances the clinical value of

these agents is moderate In controlled studies diphenoxylate

did not noticeably reduce the number nor the volume of

diarrheal stools or the amount of intravenous liquids required

by children with acute diarrhea (12 13)

In spite of these circumstances one pharmaceutical

company reported more than 25 million dollars in earnings from

the sale of Lomotil during 1983-1984 (17)

In the United States Lomotil carries a warning that it

is not a harmless drug and that the recommended dosage should

be strictly followed especially for children (9)

In the United Kingdom Lomotil has been reported as a

frequent cause of accidental poisoning through overdose in

children under five (17) Other studies indicate that small

children are highly susceptible to overdose (8) An overdose

of this medicine may cause severe respiratory depression that

can lead to a coma permanent cerebral damage or even death

Symptoms of overdose have been reported in children after only

one dose (18) After a concentrated campaign of public

awareness about this problem the company agreed to restrict

- 5 shy

the use of this product worldwide for children under two (19)

Nevertheless in many Latin American countries including

Mexico Lomotil is sold without prescription (20) Although

the fine print on the packages warns against its use in children

under six it has been verified that many mothers in our

country are unaware of these dangers

Some of the adverse reactions of Lomotil at recommended

doses include the following numbness of the limbs euphoria

depression general malaise lethargy confusion sedation

drowsiness restlessness severe headaches anaphylaxis

angioneui-otic oedema urticaria gingivitis pruritys toxic

megacolon paralytic ileus vomiting nausea anorexia

abdominal discomfort hyperthermia tachycardia urinary

retention and dryness of the skin and mucous membranes (9)

As with other medications various countries have placed

severe restrictions on its use while others have totally

eliminated it froin the market due to all of the above

mentioned side effects Australia has eliminated it from the

market (21) and the Philippines does not recommend its use

(1) However not all countries have placed restrictions on

these drugs yet

The 1984 publication of essential drugs of the Mexican

Health Sector includes diphenoxylate and atropine as

essential medicines under the heading antidiarrheals

indicating its use in cases of noninfectious diarrheas (20)

- 6 shy

II DRUGS WITH ANTISECRETORY PROPERTIES

Although many drugs have demonstrated an antisecretory

effect in experimental studies very few have been adequately

studied in clinical trials and virtually all of these have

shown serious side effects a low therapeutic effect andor

only modest efficacy For these reasons the Control of

Diarrheal Diseases Program of the World Health Organization

has clearly stated that none of these drugs can be recommended

for the treatment of acute infectious diarrhea in infants (3)

Bismuth subsalycilate in liquid form significantly

diminished the number of liquid stools as well as the

undesirable effects in young adults with travelers diarrhea

(22) but had no effect on the quantity of liquid in the

stools or the total weight of the stools implying that it had

no antisecretory effect It was also necessary to administer

a large volume (240-480 ml in less than four hours) and the

total dose of subsalycilate was too large to be practical or

safe in children

The effect of the doses of bismuth subsalycilate was

evaluated in a placebo-controlled double-blind test in

volunteers with acute diarrhea caused by enterotoxigenic

E coli This study showed no effect on the frequency or

the weight of stools (23)

Aspirin (25 mgskgday) was studied as an antisecretory

agent in a placebo-controlled double-blind test in

malnourished children with acute diarrhea after intravenous

-7shy

rehydration had been started The reduction in the daily

stool volume was statistically significant but the effective

change was only 100 ml per child which was not considered

clinically important (24)

Berberine an alcaloid used in some traditional remedies

for diarrhea has been shown to have an antisecretory effect

in animals However in two clinical trials in controlled

studies of adults with cholera or diarrhea with similar

characteristics there was no effect on the rate of stool

excretion nor was there a reduction in the rate to an extent

that could be considered clinically important (25 26)

III ACIDURIC BACTERIA

It has been recognized for a long time that the normal

aciduric bacteria in the human intestine inhibits the growth

of bacterial pathogens such as Salmonella and Shicrella Thus

it has been suggested that intestinal infections could be

treated or prevented by the ingestion of normal flora (27)

Lactobacillus acidophilus bifidobacterium and Streptococcus

faecalis are some of the frequently mentioned species The doubleshy

blind tests carried out with Streptococcus faecalis in adults

and children with acute diarrhea have reported a shortening in

length of the infection and the excretion of the pathogen

(28) Nevertheless controlled trials of the therapeutic and

prophylactic value of the Lactobacilli have not demonstrated

any benefits (29 30 31)

- 8shy

In a study carried out by students at the Universidad

Nacional Autonoma de Mexico (UNAM) it was observed that

medicines of this type were freely sold in Mexico and that

publicity for these agents widely promoted their use in infants

and children (20)

IV MEDICINES WITH ABSORPTIVE EFFECTS

Kaolin (generallly used in combination with pectin a

stabilizing agent) activiated charcoal and the clay attapulshy

gite have been proposed as antidiarrheal agents due to their

ability to collect and inactivate bacterial toxins However

clinical studies have offered little encouragement

A study published in the Journal of the American Medical

Association (11) of eighty children with acute diarrheal

illness in Guatemala tested the effectiveness of

antidiarrheal agents (a solution of kaolin and pectin and

one of liquid diphenoxilate with atropine) This study showed

that these medications were not useful in the treatment of

diarrhea specifically in acute infant diarrhea (11) They

increased the consistency of the stools but there were no

changes in the weight liquid content or the frequency of

stools

Despite its scientifically proven inefficacy kaolin and

pectin in a liquid suspension is included in the list of

essential drugs of the Mexican Health Sector (1984) and is

recommended for use in infants and preschool children under

the heading diarrhea The list states that there are no

contraindications precautions or pharmacological

- 9 shy

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

- 10 shy

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

the use of this product worldwide for children under two (19)

Nevertheless in many Latin American countries including

Mexico Lomotil is sold without prescription (20) Although

the fine print on the packages warns against its use in children

under six it has been verified that many mothers in our

country are unaware of these dangers

Some of the adverse reactions of Lomotil at recommended

doses include the following numbness of the limbs euphoria

depression general malaise lethargy confusion sedation

drowsiness restlessness severe headaches anaphylaxis

angioneui-otic oedema urticaria gingivitis pruritys toxic

megacolon paralytic ileus vomiting nausea anorexia

abdominal discomfort hyperthermia tachycardia urinary

retention and dryness of the skin and mucous membranes (9)

As with other medications various countries have placed

severe restrictions on its use while others have totally

eliminated it froin the market due to all of the above

mentioned side effects Australia has eliminated it from the

market (21) and the Philippines does not recommend its use

(1) However not all countries have placed restrictions on

these drugs yet

The 1984 publication of essential drugs of the Mexican

Health Sector includes diphenoxylate and atropine as

essential medicines under the heading antidiarrheals

indicating its use in cases of noninfectious diarrheas (20)

- 6 shy

II DRUGS WITH ANTISECRETORY PROPERTIES

Although many drugs have demonstrated an antisecretory

effect in experimental studies very few have been adequately

studied in clinical trials and virtually all of these have

shown serious side effects a low therapeutic effect andor

only modest efficacy For these reasons the Control of

Diarrheal Diseases Program of the World Health Organization

has clearly stated that none of these drugs can be recommended

for the treatment of acute infectious diarrhea in infants (3)

Bismuth subsalycilate in liquid form significantly

diminished the number of liquid stools as well as the

undesirable effects in young adults with travelers diarrhea

(22) but had no effect on the quantity of liquid in the

stools or the total weight of the stools implying that it had

no antisecretory effect It was also necessary to administer

a large volume (240-480 ml in less than four hours) and the

total dose of subsalycilate was too large to be practical or

safe in children

The effect of the doses of bismuth subsalycilate was

evaluated in a placebo-controlled double-blind test in

volunteers with acute diarrhea caused by enterotoxigenic

E coli This study showed no effect on the frequency or

the weight of stools (23)

Aspirin (25 mgskgday) was studied as an antisecretory

agent in a placebo-controlled double-blind test in

malnourished children with acute diarrhea after intravenous

-7shy

rehydration had been started The reduction in the daily

stool volume was statistically significant but the effective

change was only 100 ml per child which was not considered

clinically important (24)

Berberine an alcaloid used in some traditional remedies

for diarrhea has been shown to have an antisecretory effect

in animals However in two clinical trials in controlled

studies of adults with cholera or diarrhea with similar

characteristics there was no effect on the rate of stool

excretion nor was there a reduction in the rate to an extent

that could be considered clinically important (25 26)

III ACIDURIC BACTERIA

It has been recognized for a long time that the normal

aciduric bacteria in the human intestine inhibits the growth

of bacterial pathogens such as Salmonella and Shicrella Thus

it has been suggested that intestinal infections could be

treated or prevented by the ingestion of normal flora (27)

Lactobacillus acidophilus bifidobacterium and Streptococcus

faecalis are some of the frequently mentioned species The doubleshy

blind tests carried out with Streptococcus faecalis in adults

and children with acute diarrhea have reported a shortening in

length of the infection and the excretion of the pathogen

(28) Nevertheless controlled trials of the therapeutic and

prophylactic value of the Lactobacilli have not demonstrated

any benefits (29 30 31)

- 8shy

In a study carried out by students at the Universidad

Nacional Autonoma de Mexico (UNAM) it was observed that

medicines of this type were freely sold in Mexico and that

publicity for these agents widely promoted their use in infants

and children (20)

IV MEDICINES WITH ABSORPTIVE EFFECTS

Kaolin (generallly used in combination with pectin a

stabilizing agent) activiated charcoal and the clay attapulshy

gite have been proposed as antidiarrheal agents due to their

ability to collect and inactivate bacterial toxins However

clinical studies have offered little encouragement

A study published in the Journal of the American Medical

Association (11) of eighty children with acute diarrheal

illness in Guatemala tested the effectiveness of

antidiarrheal agents (a solution of kaolin and pectin and

one of liquid diphenoxilate with atropine) This study showed

that these medications were not useful in the treatment of

diarrhea specifically in acute infant diarrhea (11) They

increased the consistency of the stools but there were no

changes in the weight liquid content or the frequency of

stools

Despite its scientifically proven inefficacy kaolin and

pectin in a liquid suspension is included in the list of

essential drugs of the Mexican Health Sector (1984) and is

recommended for use in infants and preschool children under

the heading diarrhea The list states that there are no

contraindications precautions or pharmacological

- 9 shy

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

- 10 shy

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

II DRUGS WITH ANTISECRETORY PROPERTIES

Although many drugs have demonstrated an antisecretory

effect in experimental studies very few have been adequately

studied in clinical trials and virtually all of these have

shown serious side effects a low therapeutic effect andor

only modest efficacy For these reasons the Control of

Diarrheal Diseases Program of the World Health Organization

has clearly stated that none of these drugs can be recommended

for the treatment of acute infectious diarrhea in infants (3)

Bismuth subsalycilate in liquid form significantly

diminished the number of liquid stools as well as the

undesirable effects in young adults with travelers diarrhea

(22) but had no effect on the quantity of liquid in the

stools or the total weight of the stools implying that it had

no antisecretory effect It was also necessary to administer

a large volume (240-480 ml in less than four hours) and the

total dose of subsalycilate was too large to be practical or

safe in children

The effect of the doses of bismuth subsalycilate was

evaluated in a placebo-controlled double-blind test in

volunteers with acute diarrhea caused by enterotoxigenic

E coli This study showed no effect on the frequency or

the weight of stools (23)

Aspirin (25 mgskgday) was studied as an antisecretory

agent in a placebo-controlled double-blind test in

malnourished children with acute diarrhea after intravenous

-7shy

rehydration had been started The reduction in the daily

stool volume was statistically significant but the effective

change was only 100 ml per child which was not considered

clinically important (24)

Berberine an alcaloid used in some traditional remedies

for diarrhea has been shown to have an antisecretory effect

in animals However in two clinical trials in controlled

studies of adults with cholera or diarrhea with similar

characteristics there was no effect on the rate of stool

excretion nor was there a reduction in the rate to an extent

that could be considered clinically important (25 26)

III ACIDURIC BACTERIA

It has been recognized for a long time that the normal

aciduric bacteria in the human intestine inhibits the growth

of bacterial pathogens such as Salmonella and Shicrella Thus

it has been suggested that intestinal infections could be

treated or prevented by the ingestion of normal flora (27)

Lactobacillus acidophilus bifidobacterium and Streptococcus

faecalis are some of the frequently mentioned species The doubleshy

blind tests carried out with Streptococcus faecalis in adults

and children with acute diarrhea have reported a shortening in

length of the infection and the excretion of the pathogen

(28) Nevertheless controlled trials of the therapeutic and

prophylactic value of the Lactobacilli have not demonstrated

any benefits (29 30 31)

- 8shy

In a study carried out by students at the Universidad

Nacional Autonoma de Mexico (UNAM) it was observed that

medicines of this type were freely sold in Mexico and that

publicity for these agents widely promoted their use in infants

and children (20)

IV MEDICINES WITH ABSORPTIVE EFFECTS

Kaolin (generallly used in combination with pectin a

stabilizing agent) activiated charcoal and the clay attapulshy

gite have been proposed as antidiarrheal agents due to their

ability to collect and inactivate bacterial toxins However

clinical studies have offered little encouragement

A study published in the Journal of the American Medical

Association (11) of eighty children with acute diarrheal

illness in Guatemala tested the effectiveness of

antidiarrheal agents (a solution of kaolin and pectin and

one of liquid diphenoxilate with atropine) This study showed

that these medications were not useful in the treatment of

diarrhea specifically in acute infant diarrhea (11) They

increased the consistency of the stools but there were no

changes in the weight liquid content or the frequency of

stools

Despite its scientifically proven inefficacy kaolin and

pectin in a liquid suspension is included in the list of

essential drugs of the Mexican Health Sector (1984) and is

recommended for use in infants and preschool children under

the heading diarrhea The list states that there are no

contraindications precautions or pharmacological

- 9 shy

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

- 10 shy

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

rehydration had been started The reduction in the daily

stool volume was statistically significant but the effective

change was only 100 ml per child which was not considered

clinically important (24)

Berberine an alcaloid used in some traditional remedies

for diarrhea has been shown to have an antisecretory effect

in animals However in two clinical trials in controlled

studies of adults with cholera or diarrhea with similar

characteristics there was no effect on the rate of stool

excretion nor was there a reduction in the rate to an extent

that could be considered clinically important (25 26)

III ACIDURIC BACTERIA

It has been recognized for a long time that the normal

aciduric bacteria in the human intestine inhibits the growth

of bacterial pathogens such as Salmonella and Shicrella Thus

it has been suggested that intestinal infections could be

treated or prevented by the ingestion of normal flora (27)

Lactobacillus acidophilus bifidobacterium and Streptococcus

faecalis are some of the frequently mentioned species The doubleshy

blind tests carried out with Streptococcus faecalis in adults

and children with acute diarrhea have reported a shortening in

length of the infection and the excretion of the pathogen

(28) Nevertheless controlled trials of the therapeutic and

prophylactic value of the Lactobacilli have not demonstrated

any benefits (29 30 31)

- 8shy

In a study carried out by students at the Universidad

Nacional Autonoma de Mexico (UNAM) it was observed that

medicines of this type were freely sold in Mexico and that

publicity for these agents widely promoted their use in infants

and children (20)

IV MEDICINES WITH ABSORPTIVE EFFECTS

Kaolin (generallly used in combination with pectin a

stabilizing agent) activiated charcoal and the clay attapulshy

gite have been proposed as antidiarrheal agents due to their

ability to collect and inactivate bacterial toxins However

clinical studies have offered little encouragement

A study published in the Journal of the American Medical

Association (11) of eighty children with acute diarrheal

illness in Guatemala tested the effectiveness of

antidiarrheal agents (a solution of kaolin and pectin and

one of liquid diphenoxilate with atropine) This study showed

that these medications were not useful in the treatment of

diarrhea specifically in acute infant diarrhea (11) They

increased the consistency of the stools but there were no

changes in the weight liquid content or the frequency of

stools

Despite its scientifically proven inefficacy kaolin and

pectin in a liquid suspension is included in the list of

essential drugs of the Mexican Health Sector (1984) and is

recommended for use in infants and preschool children under

the heading diarrhea The list states that there are no

contraindications precautions or pharmacological

- 9 shy

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

- 10 shy

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

In a study carried out by students at the Universidad

Nacional Autonoma de Mexico (UNAM) it was observed that

medicines of this type were freely sold in Mexico and that

publicity for these agents widely promoted their use in infants

and children (20)

IV MEDICINES WITH ABSORPTIVE EFFECTS

Kaolin (generallly used in combination with pectin a

stabilizing agent) activiated charcoal and the clay attapulshy

gite have been proposed as antidiarrheal agents due to their

ability to collect and inactivate bacterial toxins However

clinical studies have offered little encouragement

A study published in the Journal of the American Medical

Association (11) of eighty children with acute diarrheal

illness in Guatemala tested the effectiveness of

antidiarrheal agents (a solution of kaolin and pectin and

one of liquid diphenoxilate with atropine) This study showed

that these medications were not useful in the treatment of

diarrhea specifically in acute infant diarrhea (11) They

increased the consistency of the stools but there were no

changes in the weight liquid content or the frequency of

stools

Despite its scientifically proven inefficacy kaolin and

pectin in a liquid suspension is included in the list of

essential drugs of the Mexican Health Sector (1984) and is

recommended for use in infants and preschool children under

the heading diarrhea The list states that there are no

contraindications precautions or pharmacological

- 9 shy

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

- 10 shy

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

interactions and the only undesirable effect listed is

constipation after prolonged use (11)

- 10 shy

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

SUPPLEMENT SURVEY OF ANTIDIARRHEAL SALES

Introduction

The following report is a supplementary study that intends to

illustrate the widespread abuse of antidiarrheal and antimicrobial

agents No scientific protocol or epidemiological method was

followed Nonetheless the evidence informally gathered here

should suffice to encourage the use of epidemiological methods to

formally evaluate the severity and extent of the problem in Mexico

For a long time medications have been sold freely in

pharmacies throughout Mexico Although many of the medicines have

labels that indicate that their sale requires a medical prescription

prescription medicines are sold freely over the counter The

exception is narcotics which require a prescription with both the

physicians professional identification number as well as his

registration number with the Health Secretariat Medications

are dispensed by salespersons who in the majority of cases have

little or no training in medicine or pharmacy

Throughout Mexico City hospitals clinics and health centers

are readily available A great portion of these health facilities

are government subsidized thus enabling a vast majority of the

population to have nearly free access to medical treatment at

health facilities However it is still extremely popular even

fashionable to prescribe for oneself at the local pharmacy or receive

the free advice of the encargado de la farmacia (person in charge

of the pharmacy) who will then prescribe and sell a medication

for an ailment Also popular is determining the prescription based

upon the Diccionario de Especialidades Farmaceuticas or PI the

analogue to the Physicians Desk Reference which is conveniently

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

sold in all major bookstores across the country As if consulting

the pages of the phone directory the person simply looks under

the heading which best describes his condition and will then find

a list of drugs from which to choose to combat his illness The

current edition (edition 36 1986) lists under the heading antishy

diarrheal drugs and intestinal antiseptics twenty-four that

contain nitrofurans fifteen with sulfas eleven with other

antibiotics and twenty-two simply listed under other that

include Lomotil Imodium and Kaopectate This information is

included in Annex Two along with a detailed description and

indications for each one of these drugs

Procedure

In order to investigate the indiscriminate sale of antidiarrheal

agents in the treatment of infant diarrhea in Mexico a total of four

mothers were selected from low middle and upper middle

socioeconomic strata and were asked to purchase medications at

different pharmecies located throughout Mexico City as well as in

the peripheral areas All mothers visited three pharmacies each

with a hypothetical situation of having children (a two-month-old

infant and a two-year-old child) with acute diarrhea They followed

instructions written as a questionnaire (See Annex One)

A total of twelve pharmacies located throughout the city and

outskirts were evaluated with the following results

A In eleven cases the person who prescribed gave instructions

for use or simply sold the medications was a salesperson

with little or no formal education Only in one case

-2shy

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

did a registered pharmacist prescribe tha medications

In two other cases the salesperson refused to give the

mother a prescription and referred her to a physician

for evaluation these cases subsequently were not

included in the study

B While the mother was in the pharmacy in nine cases the

salesperson asked for little or no information regarding

the childs condition However three salespersons did

ask whether the child had a fever or whether the child

was or had been vomiting The mothers gave a negative

response since they had not received instruction to say

otherwise In all twelve pharmacies visited all eleven

salespersons and the one pharmacist recommended that

mothers withhold food from the children The fasting

period that was recommended varied from a couple of hours

to twelve hours after which time the mothers were

instructed to resume feeding with teas and soft foods

for a period ranging from a day to three days

C It is interesting to point out that none of the salespershy

sons nor the pharmacist asked the mothers whether the

child was dehydrated nor did they give any indications

that the mothers should observe the children for signs of

dehydration

D In all twelve cases mothers were given prescriptions

that contained antibiotics or ones that had a combination

of antibiotic and an antidiarrheal agent Furazolidone

neomycin trimethropin and streptomycin were popular

-3shy -- 3 -

V

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

among the antibiotics prescribed In five cases mothers

were specifically instructed to return if the childrens

condition did not improve in order to buy a more expensive

better and more potent antibiotic Mothers were

instructed to give dosages of half a teaspoon of the drug

every four to six hours for the two-month-old and

instructed mothers to double the dosage for the two year

old

E In none of the twelve pharmacies did the salesperson or

harmacist warn the mother of any possible side effects

from the drugs nor of potential harm or overdose even

in the young infant

The second part of this study sought to analyze the commercial

advertising campaigns that the pharmaceutical companies carry out

in order to promote these products Implications for repercussions

the general public as well as for the physicians and medical

students will be discussed

For this exercise three medical students from the UNAM

(National Autonomous University of Mexico) were asked to request

specific information about the antidiarrheal agents that are sold

freely on the market They visited approximately twenty different

pharraceutical different laboratories that produce these medicines

and which are located for the most part in the Mexico City area or

neighboring suburbs

The students were supplied with brochures pamphlets and

free medical sample of these antidiarrheal drugs Usually

they were able to speak to the laboratorys chief of medical

-4shy

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

research since they specifically requested to receive medical

literature on these products A sampling of this publicity is

included in Annex Three

It is evident from the brochures and pamphlets that there is

little control or restriction on the marketing or publicity of

these products Most of these are medicines produced in both an

adult and an infant preparation and some clearly market their

products to the pediatric population

A closer lcok at the advertisements of these products

however will reveal that in fact many companies warn against

their use in younger children Kaopectate for example which now

sells in Mexico with a concentrated formula warns (in the fine

print in of their advertisement pamphlets) that this product

should not be used as a substitute for appropriate oral rehydration

therapy in children under two

On one visit to a pharmaceutical company however the students

were greeted by the head of the research division and given an

article on Poisoning by Loperamide in Children This was a

study performed in 1980 at the Pediatrics Hospital of the National

Medical Center in Mexico and it reviewed the cases of ten children

less than two years old who suffered intoxication by loperamide

three of them at recommended dosages (33) The article cites

some of the commercially available pediatric medications in Mexico

that contain Loperamide and gives different recommended dosages

indicated by the pharmaceutical laboratories that prcduce them

The article reviewed cases over a four month period during

which 66 of children admitted to the hospital with diagnosis of

intoxication were confiimed to be due to loperamide poisoning

-5- 27

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

It is important to point out that 904 of the patients in the study

group were children less than five months old

The article concludes that the use of loperamide for

pediatric patients should be completely banned

When interviewed the medical students felt that the

pharmaceutical laboratories are well aware of the potential

serious side effects of these medications in young infants

However a barrier to restrictions is the health authorities

reluctance and negligence to ban these products despite the fact

that deaths and high rates of intoxication from abuse and misuse

of these products have been published

Discussion and Recommendations

Questions arise when one reviews the fact that the 1984

publication of the Essential Drug List of the Mexican Health

Sector still includes diphenoxylate and Kaolin-pectin for the

treatment of diarrhea (Annex Four) Although the list does not

recommend use of these medications in children less than six years

old the pharmaceutical companies are the first to admit that

physicians frequently prescribe them for pediatric use

What about the mothers and the public in general who have

easy and unlimited access to these drugs What about the

salesperson with little or no training in medicine or pharmacy

who prescribes medications without realizing possible serious

consequences to the child

Health Action International a non-profit organization with

headquarters in The Hague Netherlands has recently issued the

following recommendations for action with regard to the worldwide

-6shy

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

abuse of antidiarrheal drugs in the treatment of infant diarrhea

These illustrate immediate actions that could be taken in Mexico

1 - Governments and health workers should make Oral Rehydration

Therapy (ORT) the treatment of choice in the majority of

cases of acute diarrhea

2 - All products containing loperamide or diphenoxylate with

atropine should be contraindicated in children under twelve

years of age

3 - All antidiarrheal products containing neomycin or any of the

oxyquinolines should be withdrawn from the market

4 - Antidiarrheal preparations with no proven efficacy such as

absorbents and intestinal bacteria supplements should be

removed from the market

5 - The use of antibacterials in treating diarrhea should be

limited to those drugs and specific indications set out in

the World Health Organization Essential Drugs List

6 - All anti-diarrheal preparations should carry a large clear

message on the package and in all information and advertising

material to the effect that ORT is the first-line therapy in

the treatment of diarrhea

The implementation of these measures would substantially

improve current diarrheal disease management for all children in

Mexico

-7shy

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

REFERENCES

1 - Tes Medicinales de la Republica Mexicana Fondos Nacional al

Recurso de los Trabajadores (FONART) 1984

2 - Health lotion International - PROBLEM DRUGS International

Organization of Consumers Unions The Hague Netherlands

3 - World Health Organization Drugs in the Management of Acute

Diarrhea in Infants and Young Children WHOCDDCMT861

4 - Health Action International Antidiarrheals IC-Imodium Problem

Drug Pack

5 - Lancet Management of Acute Diarrhea March 19 1983

p 624

6 - British National Formulary No 9 London BMA and The

Pharmaceutical Society 1985

7 - American Medical Association Drug Evaluations 5th Edition

1983 pp 1281-1293

8 - Martindale The Extra Pharmacopoeia London The

Pharmaceutical Press 28th Edition 1982 p 1061

9 - Medical Economics Company Physicians Desk Reference 39th

edition Oradell NJ 1985

10 - United Nations Consolidated List of Products whose

consumption andor sale have been banned withdrawn severely

restricted or not approved by governments First issue

revised DOC NO DIESAWPl New York July 1984

11 - Dupont HL Hornick RB Adverse effect of lomotil therapy

in shigellosis Journal of the American Medical Association

1973 225 1525-1528

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

12 - Portnoy BL Dupont HL Pruitt D Abdo JA Rodriguez JT

Antidiarrhoeal agents in the treatment of acute diarrhea in

children Journal of the American Medical Association 1976

236 844-846

13 -Harris MJ Beveridge J Diphenoxylate in the treatment of

acute gastroenteritis in children Medical Journal of

Australia 1965 22 921-922

14 -Owens JR Broadhead R Hendrickse RG Jaswal OP Gangal RN

Loperamide in the treatment of acute gastroenteritis in early

childhood Report of a two centre double-blind controlled

clinical trial Annals of Tropical Pediatrics 1981 1 135shy

141

15 -Kassem AS Madkour AA-S Massoud BZ Mahanna ZM Loperamide

in acute childhood diarrhoea A double-blind controlled trial

Journal of Diarrheal Disease Research 1983 1 10-16

16 -Diarrheal Diseases Study Group Loperamide in acute diarrhea

in childhood results of a double-blind placebo-controlled

multicentre clinical trial British Medical Journal 1984

289 1263-1267

17 - Health Action International Problem Drugs Lomotil

Antidiarrheals 1D Lomotil Problem Drugs Pack

18 - Drugs and Therapeutics Bulletin Prescribing for Acute

Diarrhea Vol 21 No 26 Dec 1983

19 - Medawar C amp Freese B Drug Diplomacy London Social

Audit 1982

20 - Medawar C The Wrong Kind of Medicine London Consumers

Association and Hodder and Stoughton 1984

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

21 - Dupont HL Sullivan P Pickering LK Haynes G Ackerman PB

Symptomatic treatment of diarrhoea with bismuth subsalicylate

among students attending a Mexican University

Gastroenterology 1979 73 715-718

22 -Graham DY Estes MK Gentry LD Double Blind comparison of

bismuth subsalicylate and placebo in the prevention and

treatment of enterotoxigenic Eschericihia coli-induced

diarrhoea in volunteers Gastroenterology 1983 85 1017shy

1022

23 -Burke V Gracey M Suharyono Sunoto Reduction by aspirin

of intestinal fluid-loss in acute childhood gastroenteritis

Lancet 1980 i 1329-1330

24 - Butlher T Rabbani 0 Knight J Sanyal H Huq M Antishy

secretory activity of berberine sulfate in acute cholera

Clinical Research 1984 32 511A

25 - Khin-Maung U Myo Khin Nyunt-Nyunt Wai Aye-Kyaw Tin U

Clinical trial of berberine in acute watery diarrhea British

Medical Journal 1985 290 1601-1605

26 - Bellomo G Mangiagi A Nicastro L Grigerio G A controlled

double-blind study of SF68 strain as a new biological preparation

treatment of diarrhea in pediatrics Current Therapeutic

Research 1980 28 927-936

27 - Lamarii E Beluisi A Guidone G Marini G Frigerio G A

double-blind comparison of two different treatments for acute

enteritis in adults Chemotherapy 1981 27 466-470

28 - Luckey TD Perspectives in intestinal microecology

Microecology and Therapy 1984 14 243-249

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

29 - Pozo-Olano J de D Warran JH Jr Gomez RG Cavazos MG

Effect of a lactobacilli preparation on travellers diarrhea

A randomized double-blind clinical trial Gastroenterology

1978 74 829-830

30 - Clements ML Levine MM Black RE Robins-Browne RM Cisneros

LA Drusano GL Lanata CR Saah AJ Lactobacillus

prophylaxis for diarrhea due to enterotoxigenic Escherichia

coli Antimicrobial Agents and Chemotherapy 1981 20 104-108

31 - Nalin DR Cash RA Kaolin and cholera Journal of the

Pakistan Medical Association 1970 20 177-182

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

ANNEX 1

QUESTIONNAIRE FOR MOTHERS WHO WILL BUY MEDICATIONS TO TREAT INFANT DIARRHEA IN DIFFERENT PHARMACIES IN MEXICO CITY AND OUTSKIRTS

SIMULATED CASE

The mother will go to a pharmacy to buy medicatins to cure

the diarrhea of her two sons a two month old infant and a two

year old child The children are not accompanying her and are

remaining with their grandmother

Below are the objectives that each mother should accomplish

during each visit to a pharmacy

1 Name and address of the pharmacy

2 Please indicate who sold the medication to you (physician

pharmacist salesperson) Otherwise please make an

estimate about the level of hisher education

3 Did this person ask you information about the childrens

illness (eg duration of the illness accompanying

symptoms etc) Please specify only if anything was

asked

4 Did the person ask you if your child was dehydrated Did

heshe give indications of how to prevent dehydration

Please specify only if anything regarding this was asked

or indicated

5 Did you receive specific instructions about the use or

dosage of the medication(s) Please specify if

applicable

6 Did the person who sold the medication to you give any

specific warnings about the medications alert you on

possible side effects or warn you of danger of overdosage

ANNEX 2

XXIII

4W 70 Facetin-O 351 Bliewta 109 Eboaven 339AtW 153 FacetinO Comprimidos oasrmn 114 Esoaven Alcalino 339

154 351 B[Imanal 134 Esoaven Enzimtico 339 D 2 Oxibeldina 657 Bkszpna 136 Espaven mo 340

330 Prodiar S 710 Bulamini 143 Gelfos 403 FW t -T 1 Prometac 714 Cant) Smoe 150 Gelmadi 404 U taL333 Stooen 799 Oebridat 234 Helopanflat 430 imni Rudesa 434 Vioftalvl 914 0iDl 273 Homafren 439 iCiam S Viotaiidina 250 914 Diodomia 273 Kestomatin 486 wwmne 87 Zetaouin 934 Espad 337 Uberan con Pipenzolat gWt m745 54Otros Hama0p 440 507 tro Lbertnm ComprimidoL UP Lioar 514

Uertim Gotas 507 Metozvme 556Tegrml 122 Acnd 2 Aiepsal Comouesto 22 dtal 9a Ubermm Inyectale58 Neo-Pdnl cticos Plus 602 Fenrdanoin 60 361 lmoim 457 Pandasa 661 Neutraforte 609 Gamibetal Complex 333 ci 4M RItz Pediatco 684 Notalbin Peditrico 628

La vi-S Peamw 433 Prpanwe 714 Ochozim 637UdI O Ro~biu Onoton 643510 Ph Pedampcai 747

ANTIDEPRESIVOS LoI=L 51 Tr Z878 Panebil 662 Monlm 578 Uum 882 Pankreotlat 664

iVbase Psicotropicos Motim Inf nd 57M Vakiine M 833 Pankreon 664 pbg XXXIV) Reg 729 Alboral GO 16 Piotal Simeric6n 684

Caosol N 150 Algosfar 25 Plasil Enzimtico 687

Diba-Pec 272 Andopan 4sect Pramidasa 695 ANTIDIABETICOS Di-Sulkin 294 Ayoral 77 Pramidasa Infantil 695

------ Espediasin 340 Baralgina 85 Pramigel 696 (V63e Diabetes medica- Kacopectate 478 Bipasmin Compuesto 114 Pramisan 696 mentos para la pg X II Laciolectin 492 Bontal 126 Reformit Enzimtico 729

Lomotil 522 Buscapina Compositum Wingel 926 ANTIDIARREmqnS Mebinol Compuesto 541 137 Zimeton 935 Y_AT TCOSySuyodil 807 Busconet 138INTiNLES Synedac 813 Buscopax 139 ANTIHELMINTICOS

INTES71NALES_ Tropatil 878 Butilamina Compuesta 143 Yosul 932 Chofabol 225 Vase Parasutosis

Cintaverin Compuesto 176 pjg XXXIII)

GvCofe4 9 ANTIEMETICOS Coleoren 119 Cofurpek 190 Contierin 207 ANTIHIPERTENSIVOS ColfurColfur Tabletas192 E 82OCi-6 226192 i 2actil-OB 2 Colfui agja 1 BRIaoUiazIabir 140 Doo-Buscapina P 305 V6ase Cardiovasculares Colistin Magma7MUa02 312 agentes pIg XXV)2 Donnatal Peai~trico 307 Diarrnan 70 Escapin 336 Esresufan-N 341 U Campirvd 507 Espacil Compuesto umm ANTIHISTAMINICOS Kaomycin 478 Lbemn Gow W7 337_____Streozomagma 800 U ~i Gots 501 3 NIISA II Trea 861 1b mm hridbe a0 Espasmo-Cibalgina 338 (Vbase AntialIrgicos y anti-Tribiocin86 M m - 542 Espasmo-Qual MTrboi83murn 07 Espasmotex 339 histamlnicos pag XIX)

2 Con nitrofuranos Naju- s 54 Homafren 439 P__ 5v Konitan 489 ANI IINFLAMATORIOS

Slriv I beran con Pipenzolato AGENTES Cofnup Gos10 va orta 507 Cofurpek 190 Tn 41 Ubrax 508 1 Uso externo Colfur 192 TCn 56 Mecoen 543

c~oir Tableas 192 Trin 87 Notalbin Peditrico 62a ENZIMATICOS Dectolin 252 VMe 924 Piptal Simeticon 684 Fibrase 365 Dectofin T 257 Vmx 94 Prodolina Compositum 711 Fibrase SA 365 -

Diarman 270 V=T 93 Retodol Comoositum 735 Fbrase-V 265 Diba-Pec 272 5VorMDL Selpiran 766 b) NO ENZIMATICOSDiba-Pec Compueso 272 Bonadoxina 123 Severin 773Ecrol 2 Clominal 184 Stelabid 798 Ktn 4WErcefurol 332 Crycimina Compuesta 218

- Lsox)Furomcedi Magma340 Digenor 275 ANTIFIBROTICOS i ruage 736Furoxona C 388 Diigan 281 Biotarson-N 113 --Hirafur 438 Emediba 3V b sm Dolaren Crema 303Hidrafur P-di trico 435 Facomicin 352 Losalen 525 Neturox CompuesroHomafyen 439 ANTIFLATULENTOSCmefuran Meclidoxina Serrar 542 c) CORTICOSTEROIDES Suime 7 Medramina-R 544 (Wase tambibn Anzcidos IV6ase tambien Corticos-Salmocice 5W 5 Nautran 594 con antllatulentos pag XIX) teroides pig XXVI)

Trea 861 Pramisan 6 30 Yosudona 932 Sleabid 798 Lber PtIi5 37 C U 01DxrmaO EM

____________ bbe i 57 Dnernao Sno 0C Og 5 Zetaquin 9P3D4 Alkagei Complex 28 Lim a 0fUIsm

ANTIESPASMODICOS Y Bromepan 133 Srwam3 Con ijif as ANTICOUNERGICOS Cionase 217 S Sov 812

Ane- 0 Digenor 275 Toom Gl aA4 Bontal 126 (Vbas tambibn Parasim- Digenor Plus 275 Caldecort 147 Enteridina M paticolitscos plg XXXIII) Dimesiel Gel M Dermaioj-C 258 Enterocaroin 3 kwsw F 51 Di-Suikin 24 LocaivnN 517 Entero-n3iyod Compuesio nqxwi ir S Ditzcax 294 Locaivn-O 518

Serral 3Zl Atavw xanom 74 Enterdina 2 519n Locaivn OtT5Imico EstresulfanN 341 B S Entozyme Compuesia 2M Losaien -25

Los oroducos aue aoarecen en letra a nacen relefencia a monotarmacas

126 BON ONARE-C an tnU a

PRESENTACIONES SONARE (Oxacepam) se presenta en INFORMACION REVISADA dos conceniraciones

Tableras de 15 mg Cai con 30 tabletas BRA CC O PRAL Tabletas do 30 mg Caja con 30 tabletas Taberas

Antes de rescrbir consults la pg VIII levendas 2 y 7C

Regs Nms 63363 y 72378 S S Ancifimico condioneWYETH-VALES S A FORMULA Cada TA8LETA

Av Poniente 134 N~m 740 02300 Mexico 0 F Pirazinamida SONARE IS y 80NARE 30 son marcas registradas Excipienie cbp

Tratamiento antituberculoso do corta duracibn quemas do tratamiento de carta duraco6n han demcsac

B 0 N T A L finitivamente su eficacia en los estudios realizados en -shypaises las ventalas que se anotan son 1) disminuvtn a

Tab eras dencia de abandonos 2) aceteran a negativizacidn aca

lAmebicida y antiespasm6dico intestinal gica 3) disminuyen la proaaoilidad de recaida 4) -I las mutantes resistentes 5) disminuven las reacciones

FOHMULA Cada TABLETA contiene les y los efecros indeseables de las drogas 6) melornn a Oiyodohidroxiauinolei a 250 mg operacidn del enfermo porque Io reintegra a sus crshya iui F- 250 mg cotidianas y 7) abaten los costos de operacidn

Carbon acivado 0 mg Metilbromuro de homatropina 3 mg Esquema aprobad par el cuadro bsico del Sector

Excipiente cbp 1 tablera lud Hasta set meses de duracion Administracidn nZoma

INDICACIONES lnfeccones intestinales causadas par Shi Fuse intensiva Administraci6n diaria do medicamenco 2 gelia coccs Proteus Disenteda ameniana Colitis lunes a s~bado durance tres meses (60 dosis)

CONTRAINDICACONES Hioersensibilidad al yodo ylo sul- Isoniacida (HAIN) 300 mg rifamoicina 600 rg estrepcnn fas Embarazo prematuros recen nacidos I g (IM) BRACCOPIRAL Ipirazinamida) 2 g (4 tatieu

REACCIONES SECUNDARIAS Ocasionalmente pueden Fase do sost6n Administracicn de medicamentos dos v oresentarse reacciones par hioersensibilidad a los comoonentes par semana durante cuatro meses 130 dosis) do la f6rmula cristalunia hemattiria Marrea transtoria vrtigo Isoniacida (HAIN) 80 mg rifampicina 600 mg neuropatia mielobptica intolerancia del yodo cefalea nbusea Actualmente se considera a la pirazinamida coma ura vdmito fiebre sindrome de Stevens-Johnson y heoatitis antifimica primaria

DOSIS Diarreas do origen bacteriano 2 a 3 tabletas 3 INDICACIONES Tuberculosis Escecirfco para el rarr-1 veces al dia con las comidas a corto plaza de la TB pulmcnar

Amebiasis 12 tabletas diarias divididas en tres tomas CONTRAINDICACIONES Insuficiencia heoAtica Y fv- durance 20 dias

Frasco con 24 tabletas REACCIONES SECUNDARIAS La producci6n de WPRESENTACION -Antes de prescribir consute la pig VII leyenda I hepdtico ha side reporada en algunos cases en la liwat

VIA DE ADMINISTRACION OralReg Ncm 89044 S S

FARMACOS CONTINENTALES S A DOSIS 2 g (4 tabletas) par dia una sola coma

Av San Ignacio N6m 1831 72570 Puebla Pue PRESENTACION Caja con 50 tabletas de 5WCOMY Antes de prescribir consulte la pig VII leyenda

Reg Nrm 0610M79 S S PRODUCTO UEV0 BRACCO DE MEXICO S A do C V

B 0 R A L E X Marca registrada

Coida isotdnico BRA TIDINA Antiseptico y germicida no irritantamp

Taberas FORMULA Cada 100 ml contionencntioenParaFORM00 LA~l ada al tratanniento do la 61care gastroduadenI

Acido b6rico 2200 g Propiloarabeno 0005 g FORMULA Cada TABLETA contiene Barato de odio 0220 g C metidina 0 Agua bidestilada cpb 100000 ml _0

INDICACIONES Tratamiento do las 61ceras 3 ACCION Antiseoico y germicida no isot6- hemorragias tracto 0externo irritance duodenaies del gastrointestinal

nico con las lgrmas esofagids patica sindrome de Zollinger-Eilison Ui A

INDICACIONES Para aclicado telidOs tan delicadosset a stress corn la cornea y el saco conluntival como irrigante oftalmico CONTRAINDICACIONES No existen contai lavar-o do secrecones acumuladas extraccon do pequefos hasta la fecna

r cuerocs cxrawos no enclavados asicoma para set usado des- REACCIONES SECUNDARIAS Se Duede Pre j shy

pues de sotuciones otalmicas astringentes oara evitar qua se transicora cefalea marea dolores musculares eruct n -pralongue ei ardor y el escozor producido par elas Raramenre so an reocrtado casos de ginecrnsJ

CONTRAINOICACIONES Hicertension ocular y galactorrea femerna

REACCIONES SECUNOARIAS Nlinguna DOSIS La oue ei -nedico seriate

DOSIS Y ADMINISTRACION Aplicar 3 6 4 veces al dia PRESENTACION aiacOn 20 tabletas

con lavanlos 0 o1eto Antes - ptfc onur a aq VieI

PRESENTACION asco 1P 210ml Peq Num 037p11MC S S Anres d recrfoir consufe la Dq VIII leven I Heclri en 14rc 3otr

1er 53 S OELBRA ESPECALIDAOES A MACEUTICA 5Nurn S

XXIII

4W 70 Facetin-O 351 Bliewta 109 Eboaven 339AtW 153 FacetinO Comprimidos oasrmn 114 Esoaven Alcalino 339

154 351 B[Imanal 134 Esoaven Enzimtico 339 D 2 Oxibeldina 657 Bkszpna 136 Espaven mo 340

330 Prodiar S 710 Bulamini 143 Gelfos 403 FW t -T 1 Prometac 714 Cant) Smoe 150 Gelmadi 404 U taL333 Stooen 799 Oebridat 234 Helopanflat 430 imni Rudesa 434 Vioftalvl 914 0iDl 273 Homafren 439 iCiam S Viotaiidina 250 914 Diodomia 273 Kestomatin 486 wwmne 87 Zetaouin 934 Espad 337 Uberan con Pipenzolat gWt m745 54Otros Hama0p 440 507 tro Lbertnm ComprimidoL UP Lioar 514

Uertim Gotas 507 Metozvme 556Tegrml 122 Acnd 2 Aiepsal Comouesto 22 dtal 9a Ubermm Inyectale58 Neo-Pdnl cticos Plus 602 Fenrdanoin 60 361 lmoim 457 Pandasa 661 Neutraforte 609 Gamibetal Complex 333 ci 4M RItz Pediatco 684 Notalbin Peditrico 628

La vi-S Peamw 433 Prpanwe 714 Ochozim 637UdI O Ro~biu Onoton 643510 Ph Pedampcai 747

ANTIDEPRESIVOS LoI=L 51 Tr Z878 Panebil 662 Monlm 578 Uum 882 Pankreotlat 664

iVbase Psicotropicos Motim Inf nd 57M Vakiine M 833 Pankreon 664 pbg XXXIV) Reg 729 Alboral GO 16 Piotal Simeric6n 684

Caosol N 150 Algosfar 25 Plasil Enzimtico 687

Diba-Pec 272 Andopan 4sect Pramidasa 695 ANTIDIABETICOS Di-Sulkin 294 Ayoral 77 Pramidasa Infantil 695

------ Espediasin 340 Baralgina 85 Pramigel 696 (V63e Diabetes medica- Kacopectate 478 Bipasmin Compuesto 114 Pramisan 696 mentos para la pg X II Laciolectin 492 Bontal 126 Reformit Enzimtico 729

Lomotil 522 Buscapina Compositum Wingel 926 ANTIDIARREmqnS Mebinol Compuesto 541 137 Zimeton 935 Y_AT TCOSySuyodil 807 Busconet 138INTiNLES Synedac 813 Buscopax 139 ANTIHELMINTICOS

INTES71NALES_ Tropatil 878 Butilamina Compuesta 143 Yosul 932 Chofabol 225 Vase Parasutosis

Cintaverin Compuesto 176 pjg XXXIII)

GvCofe4 9 ANTIEMETICOS Coleoren 119 Cofurpek 190 Contierin 207 ANTIHIPERTENSIVOS ColfurColfur Tabletas192 E 82OCi-6 226192 i 2actil-OB 2 Colfui agja 1 BRIaoUiazIabir 140 Doo-Buscapina P 305 V6ase Cardiovasculares Colistin Magma7MUa02 312 agentes pIg XXV)2 Donnatal Peai~trico 307 Diarrnan 70 Escapin 336 Esresufan-N 341 U Campirvd 507 Espacil Compuesto umm ANTIHISTAMINICOS Kaomycin 478 Lbemn Gow W7 337_____Streozomagma 800 U ~i Gots 501 3 NIISA II Trea 861 1b mm hridbe a0 Espasmo-Cibalgina 338 (Vbase AntialIrgicos y anti-Tribiocin86 M m - 542 Espasmo-Qual MTrboi83murn 07 Espasmotex 339 histamlnicos pag XIX)

2 Con nitrofuranos Naju- s 54 Homafren 439 P__ 5v Konitan 489 ANI IINFLAMATORIOS

Slriv I beran con Pipenzolato AGENTES Cofnup Gos10 va orta 507 Cofurpek 190 Tn 41 Ubrax 508 1 Uso externo Colfur 192 TCn 56 Mecoen 543

c~oir Tableas 192 Trin 87 Notalbin Peditrico 62a ENZIMATICOS Dectolin 252 VMe 924 Piptal Simeticon 684 Fibrase 365 Dectofin T 257 Vmx 94 Prodolina Compositum 711 Fibrase SA 365 -

Diarman 270 V=T 93 Retodol Comoositum 735 Fbrase-V 265 Diba-Pec 272 5VorMDL Selpiran 766 b) NO ENZIMATICOSDiba-Pec Compueso 272 Bonadoxina 123 Severin 773Ecrol 2 Clominal 184 Stelabid 798 Ktn 4WErcefurol 332 Crycimina Compuesta 218

- Lsox)Furomcedi Magma340 Digenor 275 ANTIFIBROTICOS i ruage 736Furoxona C 388 Diigan 281 Biotarson-N 113 --Hirafur 438 Emediba 3V b sm Dolaren Crema 303Hidrafur P-di trico 435 Facomicin 352 Losalen 525 Neturox CompuesroHomafyen 439 ANTIFLATULENTOSCmefuran Meclidoxina Serrar 542 c) CORTICOSTEROIDES Suime 7 Medramina-R 544 (Wase tambibn Anzcidos IV6ase tambien Corticos-Salmocice 5W 5 Nautran 594 con antllatulentos pag XIX) teroides pig XXVI)

Trea 861 Pramisan 6 30 Yosudona 932 Sleabid 798 Lber PtIi5 37 C U 01DxrmaO EM

____________ bbe i 57 Dnernao Sno 0C Og 5 Zetaquin 9P3D4 Alkagei Complex 28 Lim a 0fUIsm

ANTIESPASMODICOS Y Bromepan 133 Srwam3 Con ijif as ANTICOUNERGICOS Cionase 217 S Sov 812

Ane- 0 Digenor 275 Toom Gl aA4 Bontal 126 (Vbas tambibn Parasim- Digenor Plus 275 Caldecort 147 Enteridina M paticolitscos plg XXXIII) Dimesiel Gel M Dermaioj-C 258 Enterocaroin 3 kwsw F 51 Di-Suikin 24 LocaivnN 517 Entero-n3iyod Compuesio nqxwi ir S Ditzcax 294 Locaivn-O 518

Serral 3Zl Atavw xanom 74 Enterdina 2 519n Locaivn OtT5Imico EstresulfanN 341 B S Entozyme Compuesia 2M Losaien -25

Los oroducos aue aoarecen en letra a nacen relefencia a monotarmacas

126 BON ONARE-C an tnU a

PRESENTACIONES SONARE (Oxacepam) se presenta en INFORMACION REVISADA dos conceniraciones

Tableras de 15 mg Cai con 30 tabletas BRA CC O PRAL Tabletas do 30 mg Caja con 30 tabletas Taberas

Antes de rescrbir consults la pg VIII levendas 2 y 7C

Regs Nms 63363 y 72378 S S Ancifimico condioneWYETH-VALES S A FORMULA Cada TA8LETA

Av Poniente 134 N~m 740 02300 Mexico 0 F Pirazinamida SONARE IS y 80NARE 30 son marcas registradas Excipienie cbp

Tratamiento antituberculoso do corta duracibn quemas do tratamiento de carta duraco6n han demcsac

B 0 N T A L finitivamente su eficacia en los estudios realizados en -shypaises las ventalas que se anotan son 1) disminuvtn a

Tab eras dencia de abandonos 2) aceteran a negativizacidn aca

lAmebicida y antiespasm6dico intestinal gica 3) disminuyen la proaaoilidad de recaida 4) -I las mutantes resistentes 5) disminuven las reacciones

FOHMULA Cada TABLETA contiene les y los efecros indeseables de las drogas 6) melornn a Oiyodohidroxiauinolei a 250 mg operacidn del enfermo porque Io reintegra a sus crshya iui F- 250 mg cotidianas y 7) abaten los costos de operacidn

Carbon acivado 0 mg Metilbromuro de homatropina 3 mg Esquema aprobad par el cuadro bsico del Sector

Excipiente cbp 1 tablera lud Hasta set meses de duracion Administracidn nZoma

INDICACIONES lnfeccones intestinales causadas par Shi Fuse intensiva Administraci6n diaria do medicamenco 2 gelia coccs Proteus Disenteda ameniana Colitis lunes a s~bado durance tres meses (60 dosis)

CONTRAINDICACONES Hioersensibilidad al yodo ylo sul- Isoniacida (HAIN) 300 mg rifamoicina 600 rg estrepcnn fas Embarazo prematuros recen nacidos I g (IM) BRACCOPIRAL Ipirazinamida) 2 g (4 tatieu

REACCIONES SECUNDARIAS Ocasionalmente pueden Fase do sost6n Administracicn de medicamentos dos v oresentarse reacciones par hioersensibilidad a los comoonentes par semana durante cuatro meses 130 dosis) do la f6rmula cristalunia hemattiria Marrea transtoria vrtigo Isoniacida (HAIN) 80 mg rifampicina 600 mg neuropatia mielobptica intolerancia del yodo cefalea nbusea Actualmente se considera a la pirazinamida coma ura vdmito fiebre sindrome de Stevens-Johnson y heoatitis antifimica primaria

DOSIS Diarreas do origen bacteriano 2 a 3 tabletas 3 INDICACIONES Tuberculosis Escecirfco para el rarr-1 veces al dia con las comidas a corto plaza de la TB pulmcnar

Amebiasis 12 tabletas diarias divididas en tres tomas CONTRAINDICACIONES Insuficiencia heoAtica Y fv- durance 20 dias

Frasco con 24 tabletas REACCIONES SECUNDARIAS La producci6n de WPRESENTACION -Antes de prescribir consute la pig VII leyenda I hepdtico ha side reporada en algunos cases en la liwat

VIA DE ADMINISTRACION OralReg Ncm 89044 S S

FARMACOS CONTINENTALES S A DOSIS 2 g (4 tabletas) par dia una sola coma

Av San Ignacio N6m 1831 72570 Puebla Pue PRESENTACION Caja con 50 tabletas de 5WCOMY Antes de prescribir consulte la pig VII leyenda

Reg Nrm 0610M79 S S PRODUCTO UEV0 BRACCO DE MEXICO S A do C V

B 0 R A L E X Marca registrada

Coida isotdnico BRA TIDINA Antiseptico y germicida no irritantamp

Taberas FORMULA Cada 100 ml contionencntioenParaFORM00 LA~l ada al tratanniento do la 61care gastroduadenI

Acido b6rico 2200 g Propiloarabeno 0005 g FORMULA Cada TABLETA contiene Barato de odio 0220 g C metidina 0 Agua bidestilada cpb 100000 ml _0

INDICACIONES Tratamiento do las 61ceras 3 ACCION Antiseoico y germicida no isot6- hemorragias tracto 0externo irritance duodenaies del gastrointestinal

nico con las lgrmas esofagids patica sindrome de Zollinger-Eilison Ui A

INDICACIONES Para aclicado telidOs tan delicadosset a stress corn la cornea y el saco conluntival como irrigante oftalmico CONTRAINDICACIONES No existen contai lavar-o do secrecones acumuladas extraccon do pequefos hasta la fecna

r cuerocs cxrawos no enclavados asicoma para set usado des- REACCIONES SECUNDARIAS Se Duede Pre j shy

pues de sotuciones otalmicas astringentes oara evitar qua se transicora cefalea marea dolores musculares eruct n -pralongue ei ardor y el escozor producido par elas Raramenre so an reocrtado casos de ginecrnsJ

CONTRAINOICACIONES Hicertension ocular y galactorrea femerna

REACCIONES SECUNOARIAS Nlinguna DOSIS La oue ei -nedico seriate

DOSIS Y ADMINISTRACION Aplicar 3 6 4 veces al dia PRESENTACION aiacOn 20 tabletas

con lavanlos 0 o1eto Antes - ptfc onur a aq VieI

PRESENTACION asco 1P 210ml Peq Num 037p11MC S S Anres d recrfoir consufe la Dq VIII leven I Heclri en 14rc 3otr

1er 53 S OELBRA ESPECALIDAOES A MACEUTICA 5Nurn S

126 BON ONARE-C an tnU a

PRESENTACIONES SONARE (Oxacepam) se presenta en INFORMACION REVISADA dos conceniraciones

Tableras de 15 mg Cai con 30 tabletas BRA CC O PRAL Tabletas do 30 mg Caja con 30 tabletas Taberas

Antes de rescrbir consults la pg VIII levendas 2 y 7C

Regs Nms 63363 y 72378 S S Ancifimico condioneWYETH-VALES S A FORMULA Cada TA8LETA

Av Poniente 134 N~m 740 02300 Mexico 0 F Pirazinamida SONARE IS y 80NARE 30 son marcas registradas Excipienie cbp

Tratamiento antituberculoso do corta duracibn quemas do tratamiento de carta duraco6n han demcsac

B 0 N T A L finitivamente su eficacia en los estudios realizados en -shypaises las ventalas que se anotan son 1) disminuvtn a

Tab eras dencia de abandonos 2) aceteran a negativizacidn aca

lAmebicida y antiespasm6dico intestinal gica 3) disminuyen la proaaoilidad de recaida 4) -I las mutantes resistentes 5) disminuven las reacciones

FOHMULA Cada TABLETA contiene les y los efecros indeseables de las drogas 6) melornn a Oiyodohidroxiauinolei a 250 mg operacidn del enfermo porque Io reintegra a sus crshya iui F- 250 mg cotidianas y 7) abaten los costos de operacidn

Carbon acivado 0 mg Metilbromuro de homatropina 3 mg Esquema aprobad par el cuadro bsico del Sector

Excipiente cbp 1 tablera lud Hasta set meses de duracion Administracidn nZoma

INDICACIONES lnfeccones intestinales causadas par Shi Fuse intensiva Administraci6n diaria do medicamenco 2 gelia coccs Proteus Disenteda ameniana Colitis lunes a s~bado durance tres meses (60 dosis)

CONTRAINDICACONES Hioersensibilidad al yodo ylo sul- Isoniacida (HAIN) 300 mg rifamoicina 600 rg estrepcnn fas Embarazo prematuros recen nacidos I g (IM) BRACCOPIRAL Ipirazinamida) 2 g (4 tatieu

REACCIONES SECUNDARIAS Ocasionalmente pueden Fase do sost6n Administracicn de medicamentos dos v oresentarse reacciones par hioersensibilidad a los comoonentes par semana durante cuatro meses 130 dosis) do la f6rmula cristalunia hemattiria Marrea transtoria vrtigo Isoniacida (HAIN) 80 mg rifampicina 600 mg neuropatia mielobptica intolerancia del yodo cefalea nbusea Actualmente se considera a la pirazinamida coma ura vdmito fiebre sindrome de Stevens-Johnson y heoatitis antifimica primaria

DOSIS Diarreas do origen bacteriano 2 a 3 tabletas 3 INDICACIONES Tuberculosis Escecirfco para el rarr-1 veces al dia con las comidas a corto plaza de la TB pulmcnar

Amebiasis 12 tabletas diarias divididas en tres tomas CONTRAINDICACIONES Insuficiencia heoAtica Y fv- durance 20 dias

Frasco con 24 tabletas REACCIONES SECUNDARIAS La producci6n de WPRESENTACION -Antes de prescribir consute la pig VII leyenda I hepdtico ha side reporada en algunos cases en la liwat

VIA DE ADMINISTRACION OralReg Ncm 89044 S S

FARMACOS CONTINENTALES S A DOSIS 2 g (4 tabletas) par dia una sola coma

Av San Ignacio N6m 1831 72570 Puebla Pue PRESENTACION Caja con 50 tabletas de 5WCOMY Antes de prescribir consulte la pig VII leyenda

Reg Nrm 0610M79 S S PRODUCTO UEV0 BRACCO DE MEXICO S A do C V

B 0 R A L E X Marca registrada

Coida isotdnico BRA TIDINA Antiseptico y germicida no irritantamp

Taberas FORMULA Cada 100 ml contionencntioenParaFORM00 LA~l ada al tratanniento do la 61care gastroduadenI

Acido b6rico 2200 g Propiloarabeno 0005 g FORMULA Cada TABLETA contiene Barato de odio 0220 g C metidina 0 Agua bidestilada cpb 100000 ml _0

INDICACIONES Tratamiento do las 61ceras 3 ACCION Antiseoico y germicida no isot6- hemorragias tracto 0externo irritance duodenaies del gastrointestinal

nico con las lgrmas esofagids patica sindrome de Zollinger-Eilison Ui A

INDICACIONES Para aclicado telidOs tan delicadosset a stress corn la cornea y el saco conluntival como irrigante oftalmico CONTRAINDICACIONES No existen contai lavar-o do secrecones acumuladas extraccon do pequefos hasta la fecna

r cuerocs cxrawos no enclavados asicoma para set usado des- REACCIONES SECUNDARIAS Se Duede Pre j shy

pues de sotuciones otalmicas astringentes oara evitar qua se transicora cefalea marea dolores musculares eruct n -pralongue ei ardor y el escozor producido par elas Raramenre so an reocrtado casos de ginecrnsJ

CONTRAINOICACIONES Hicertension ocular y galactorrea femerna

REACCIONES SECUNOARIAS Nlinguna DOSIS La oue ei -nedico seriate

DOSIS Y ADMINISTRACION Aplicar 3 6 4 veces al dia PRESENTACION aiacOn 20 tabletas

con lavanlos 0 o1eto Antes - ptfc onur a aq VieI

PRESENTACION asco 1P 210ml Peq Num 037p11MC S S Anres d recrfoir consufe la Dq VIII leven I Heclri en 14rc 3otr

1er 53 S OELBRA ESPECALIDAOES A MACEUTICA 5Nurn S

192 COL

C 0 F U R amp -sen

Astringente antis6ptico y antiespasmddico intestinal

COMPOSICION Una vez reconstituida la SUSPENSION ORAL cada 100 mli conrienen

u a e 250 mgud(equivalencea1665 mg de colistin base) gFurazolidona 300 mgC_ro iida- de 33 mg g

Pecrina 60 mg Venicuo cbp 100 mi

ACCION Y USOS COLFUR es una combinaci6n sin~rgicade dosi-individualmenre efecvvas de colistin y de furazolido na los dos antmicroOianos poderosos c nira los enteropar gens aurctonos Escherichia coa Shigella Salmonedla Para-colon Aerobacter Proteus

Su actividad sinergica comtare eficazmenre las infecciones gastroincestinales independienremenre del organismo causal

COLFUR es una combinacibn bactericida qua impide [a apashyric6n de cePas resistences

Controla 6oidamante (as diarrea prcducidas par virus ytexinas intestinales

Ejerce una accin astringente quo deviene rlpidamente a diarrea

Reduce el hiperperiscalismo suprime el cblico y previene la desliidrataci~n

COLFUR es pricicamente at~xico pcrque sus dos andmicro-bianos no Se bsroten y la diciclomina se encuentra despro-vista de accion atropinica

COLFUR la teraoia causal y sintomtdc3 de las diarreas se encuentra indicado en el tratamieno de las gastroenterids ente-ntis enterocolitis diarrea aguea infantdI y diarreas inespeclicas

CONTRAINOICACIONES Personas hitsersensibles a aigunode os comoonentes de la frmula y glaucoma agudoen

REACCIONES SECUNOARIAS Nuseas vdmito eru shyciones cuneas constipacin ADMINISTRACION Y POSOLOGIA La posologia de COL-

FUR debe calcularse en funcidn de la actividad de colistnbaseikg al r~gimen de 20-25 mgkgdia reoartidos en 4 a 6 fracciones (promedio 1 a 2 cucharaditas cada 4 a 6 horassegin a edad y el peso del n0a)

PRESENTACION Fresco con 60 ml Antes de prescrii consulte ba pig VIII leyenda 2

Reg N6m 70452 S S CARTER WALLACE S A

Prol Ingenieros Militares Nrm 76 11410 Mexico 0 F

C 0 L F U R

Tableras

Antibi6tico antisbptico y antiespasm6dico intestinal

FORMULA Cada TABLErA contlene Sulfato de colistin equivalentdeg a 166 mg

de colistin base Furazzhieona 500 mgDivodonidroxicuina 1500 mgCornidraro de diciclomina 50 rngExcoente c I taolera

ACCION Y USOS COLFUR anletas comboa en su fdrmula dos oacterczdas etiecjvos el coisrin y la furazolicona aara comoatr Ias nrertis y gastroonteritis causadas por Escr~qr~cniacOih enterooatoena Shjqeita Saimoneila Hatnea IoaracoenKleosiela-A 3r-0ac-er aOofeus COrm1ona aJemas avoi aroxaun1 a a uLiraoheOna ara a desrJccOn nesta1 oe ias ameoas y 31arrIs causantes Ce Ciarrel ornrozoara

C -r o1f- a s u 1CCOn eficicgica n a j irOn ia -fomnra oara 11ucr I ZnqMn

COLFUR es el tratamento eoiclgico y sintoma- diarreas

CONTRAINDICACIONES Pacientes hipersensib5 componence de a formula Cuando exise franca r naria 61cera iqrica esrenosante y obstrucci~n P i - -adenal Puede sin embargo administrarse a pac - glaucoma o hipertrofia prostarica

REACCIONES SECUtLJARIAS Prdcricamente libre -u

ciones atropinicas ius Fiectos indeseables se limitan jciones de plenirud epigastrca desvanecimienro yioPOSOLOGIA Nifios de 5 a 12 afios I tablera cada 4 a 6 roc= Adultos 2 tabletas cada 6 horas PRESENTACION Frasco con 12 tabletas

Antes de prescribir consulte la pig VIII eyejRegNr 7246 S S

R WALL72 S S CARTER WALLACE S A

Proj ingenirros Militares Ntm 76 11410 Meco

EDITORIAL CIENTIFICA S A de C V

UNA NUEVA GENERACION I

I

E BDE LIBROS PROFESIONALES

PARA LAS CIENCIAS DE LA

SALUD CON LA EXPER1IENCIA

DE UNA EDITORIAL CON TRADICION

San Bernardio No 17 Col del Vail2

03100 Mxico DF Tel 687-1311

NOTAS

[

328 ENF ENC04481CL 0-C a nti nU 4

CONTRAINOICACIONES Hasta anora no se conocen

PRECAUCIONES Ert ndros eretitscas ante tudo tras admiCshynistrac16n de dosis elevadas puede producirse a veces un au-

mento no deseado de la impulsividad qua puede controlarse reduciendo la dosis Para evitar tra-sornos del suerfo en nishy

os la dosis uitima del dia no debe administrarse a horas avanzadas de la tarde a por la noche

REACCIONES SECUNDARIAS Raramente en caso de hiper-

sensibildad indadual pueden apaeLer diversas reacciones aler-

gicas esoecialmence cutaneas asi como alteraciones del gusto

que remicen al suspender el ratamienco Los pacrentes con reumacisma articular cronico (artrais reumaroidel son ms pro-pensos baio tratamiento con piritinol a pacocer efecros no deseados en eilos es preciso controlar regularrnente el cuadro hem tico la orina y la funci6n heoatica

INTERACCIONES MEDICAMENTOSAS Hioe-sansibilidad al medicamento

DOSIS- DURACION DEL TRATAMIENTO

Adultos 300-6WC mg diarios reaartioos en 3 comas al dia

Nifias 50-3W0 mg ciarios 1i a 3 cucharaditas seg6n edad

e indicaci6n

Dado quoa l accion se inicia gradualmente el tratamiento

deie durar coma minima de 6 a 8 semanas En enfermedades cr6nicas puede proseguirse el tratamiento durante un periodo mas largo

ENCEPHABOL 200 mg Envasa con 24 grageas ENCEPHAEOL 100 mg Envase con 24 grageas

Frasca con 120 l

Antes do prescibir consulte la pag VIII leyenda 1

Regs Nrns 61495 y 66191 S S

MERCX-MEXICO S A

Calle 5 N6m 7 53370 Naucalpan de Juarez Edo de Mdxico

Marco registrada

E N F A L A C

Vdase Seccidn de

A P R 0 DL IM EN

U C T 0 S TIC IOS SN

M E A J0HNSON

oE MrErXIcaLA DE CV

Calz do Tlaloan Nim Z6 04000 Mexico D F

Marco registrada

E N T E R D NA -Talta[

Taleras ~

Antis6ptico Intestinal

FORMULA Coda TABLETA contiene

OivodtjdrpcaLa 015 g Ftalil-sulfacacamida 020 g Succrnil-sulfatiazol 020 g Tanato de caseina 005 g Pectina cittica 005 g

EAcpience cbp I tableta

INDICACIONES 0ienterias amebianas y bacilares Oiarreas

estivales coitra ulcerativa intecciosa y muccmemoranosa Pro-filaxis zrt pre y postooeratorio intestinal

CONTRAINDICACIONES Concraindicada en Ii constipacion

en personas hiperseisibles a las sulfas a al odo

REACCIONES SECUNOARIAS Puede producir nausea vomito y eruocon cutanea

DOSIS De 1 a 4 canletas tresecs al dia

PRESENTACONES Tuoas de 0 y 00 tabletas

Anrs do Drescnbir consuire a 0aq WkIIevend-1 I

Reg Num 435- S S

LAORATORIOS MANUELL S A 7 n- - -1 - 3 5 73 l

E N T E R O C A R B I N

Comorfrdos

Auxiliar en al traramiento de la amebiasis

FORMULA Cada COMIPRIMIDO condone

Ftallsulfacnazol 0200

Succinilsulfabiazot 0200 g

Diyoaohidrcxiquinoieina 0100

Carbon 0200 3

Metilbroruro de homarooina 0002 3

Exctpiente c I

INOICACijNES En el traramiento de ameoiasis e

nes intestinales causadas par smigelfas y salmonellas CONTRAINDICACIONES Personas hipersensables a las

glaucoma Hipersensibiload al yoco anuria oliguriansushycia hepico y renal displasia meoular embarazos premair reciin nacidos

PRECAUCIONES- Evitesa ingerir bebidas alcohalicas durut el tratamiento

REACCIONES SECUNDARIAS Puece presentarse na- vdmito eruoci6n cutanea y sequedad de boca Ocasionaar- pueden presentarse reaciones par hipersensibilidad a los cushyponentes de [a f6rmula a diarrea transitorra vertigo neuri 4

tia mielo6pcica cefalea fieore sindrome de Stevens-Jonnsun y hepatitis

DOSIS Adultos DOe 2 a 3 comprimidos 3 veces al ca con los alimentos durance 10 dias Nifios de a 6 ao

De Y a i comorimiuo 3 veces al dia durance el ienw

clue indique el medico 6 a 12 aios De ia I comnrnmxJ

3 veces al dia durante el tiemoa qua indique el medico

PRESENTACION Caja con 24 comprimidos

Antes de prescribir consulte la pag VIII leyenda I

Reg NrOm 52215 S S

INDEX DE MEXICO S A

LABORATORIO DE PRODUCTOS MEDICINALES

Fragonard N6m 40 03910 Mxico 0 r

Marca regiscrada

E N T E R 0 C 0 L S I N _ER C LIIN

Suspensidn ingernble

FORMULA Coda AMPOLLETA contiene los siguientV5 g6rmenes muertos

Streptococcus faecalis 10 000 inidl(c EkT1nnna - 20 000 m

wi r

Vehicula cb

vINDICACIONES Vacuna oral Puede asociarse a tOdO

tamiento con anribidtbcos a sulfas

CONTRAINOICACIONES Idiosincrasia a alguno de 1

componences de Ia 16rmula

REACCIONES SECUNDARIAS Estrefiimiento ocasoarJ

DOSIS De 3 a 6 ampolletas par las maiianas mediJ t

antes del desauno durance 5 dias Repetir el tra J v I mes y 3 meses aepubs

Coma vacuna oral 3 amoolletas antes de coda durance 10 dlas y I ampolleta diarna durance 30 a 60 -

PRESENTACION Caja con 6 Ampulas bebibles de 5

ntes de prescnbir consulte la pJ g VI eyendJ7

Reg Nim 82S06 S S LABORATORIOS DR ZAPATA S A

Una empresa del GRUPO PHARMA

Antigua Av de las Granjas N6m 625 02520 Mexic0- 0

Marca registrada

-1 1 Los laboraroras farmacoudicos acen un Ioable esuerzo 0o0 1 f

a H Cuerpo Wdico mericano sta ocra cenihca Les vedit1

tan amaOes de xor-sar su agra Cecrrtenro j esros aaorarout itmenalrsa cjCitujd jr ntesrji e coorcon3ne n f0rrrji J t-

verz onca y cOar-cler3 acre us roduccS v

5

bull-5 Adultos 4 taletas al d (12 g) en una sofa

dsar por 2 03dias

t-- o 60 mgkg de peso len una sofa tama die 2 6 3 dias

b-asis hep~tic Adultos 4 tablotas al dia (2 g) diaria por 3 a 5 dias- sofao 60tomamgkg de psen una sol oma diara

5 0i a0 peso3 a 5 das

S y tricomoniasis Adultos 4 taait s al dia

G- len una sofa ioma un sulo dial

reco-Nios 50 a 75 mgkg en una toma al dia Se oa tratamiento simuftneoel nes pot anaerobios Aduftos inicialmente 4 ta-

as (2 g) en una sofa toma el primer dia y se conti-racon 2 tailetas 11g) en una sofa toma por 5 0 6 dias

4 tableshydo colon Adultosdo cirugiapreoeratorio en una sofa toma 12 horas antes de la cirugia So

sofa vez desoues de -imienda tomar las tabletas una amentos de preferencia en la noche

p-tsENTACION Caja con 8 tabletas de 500 mg de prescrbir consure le peg VIII Ioenda 2

Reg Nim 86516 S S Hecho en M~xico port

LABORATORIOS GROSSMAN S A Segn f6rmula de

Armour Pharmaceutical Co

ie Tialpan NCm 2021 04040 Mtxica 0 F registrada

E S T R E P T 0 M C N A S Solucidn inyectable Lakeside

Auxiliar on al tratamiento do algunas infecciones

1 oducidas por g6rmenes grampositivos y gramnegativos

Cada FRASCO AMPULA contiene 10 g deFORMULA tpiomcina base coma sulfato Diluente 2 ml

INDICACIONES En infecciones producidas por g~rmenes los rubercuiosos siemshyx-nnegatrvos Tuberculosis En procesos

pv oeoe asociarSe con aiguno d_ Ids aniifiniccs especificosES~ a sal

renales lesi6n del Vill par craneal CONTRAINDICACIONES Idiosincrasia Ia padecimien-

REACCiONES SECUNDARIAS Lesi6n vestibular insuficien-o renal discrasias sanguineas rash

DOSIS Adultos En lesionfs tubenulnsas deberf iniciarse el tratashy

--n con I g diaro haste que a juicio del medico se re--pot semana la doss_

NiAos 20 mg pot kg de peso en las mismas condiciones ow en el adulto

PRESENTACION Caja con 1 frasco hmpula

Antes de prescuibir consulte I pag VII leyenda 5

Req Num 47876 S S

Hecho en Mexico port

FARMACEUTICOS LAKESIDE S A= do C V

Via Isidro Fabela Nim 1536 Norte

50030 Toluca do Lerdo Edo de Mex

MLaca registrada

E S T R E S U L F A _N N ENrA

CJosias y s onsomnio

Antisbptico intestinal y anticolin~rgico

- SUSPENSIONFORMULAS CAPSULAS Cara ctpsula Cada 100 ml

contione contienen

de estrepomicina) g---ente a 75 mg 150 --e n-oao75mc1n0base

- tioC zna base 2-m mg 400 g

EST 341

Metibromuro de pioenshyzolato 2 mg 25 m

Caolin 20 g

Pectina 100 g Una cucharadita de 5 ml contiene 200 mg de sulfaaiacina y

75 mg de sulfato de estreptomicina

DESCRIPCION Es una combinaci6n de antibidtico de amplio espectro con un quimioterapico sintetco muy efecivo contra los cuadros diarreicos comunes y corrientes con una

actividad antimicrobiana muy efectiva y con muy baja toxicicad

en tratamiento de diarreas pot Esshy

cherichia coli Saimonellas Shigellas a pot germenes no esshypecificos

CONTRAINDICACIONES Alergia a sulfamidas insuficiencia

INDICACIONES Util el

renal yo hepatica Glaucoma hipertrofia prostitica y pil6rica

indicadas porPRECAUCIONES Debe utilizarse a las dosis no mas de 5 dias Se deberan evitar las bebidas alcoh6licas

REACCIONES SECUNDARIAS En dosis elevadas puede

producir cristaluria nefrosis hepatitis toxica hematuria

USO DURANTE EL EMBARAZO Y LACTANCIA Se puede utilizar dur~nte el emoarazo y lactancia a las dosis inshy

dicadas y bajo vigilancia medica

VIA DE ADMINISTRACION Oral DOSIS

Adulto A juicio del m~dico Se sugieren de 2 a 4 cApshy

sulas cada 4 horas dependiendo del peso Nifios cuchashyradita de suspensi6n por kg de peso al dia fraccionando ladosis y administrandola cada 4 hores o la que el medico seshyfiale

Duraci6n minima del tratamiento Durante 5 dias

PRESENTACIONES CApsulas Caja con 20 Susponsi6n Caja con frasco de 60

ml y cucharilla dosificadora de 5 ml

Antes de prescribir consulte la pig VIII leyenda 2

Regs Nms 8403 y 84174 S S

LABORATORIOS INFAN S A

Calzada de Tlalpan N~m 4515 14050 Mexico D F

TR 0 N0 L FES TA 0ONO0L-F

Solucion inyectable

Estr6geno progestacional FORMULA Cada AMPOLLETA do 1 ml condone

Progesterona 50 mg

3 mg Aceite de sesamo cbp 1 mlBenzoato de estradiol

INOICACIONES Irregularidades del ciclo dismenorrea enshydometriosis masiodinia tensidn premenstrual esterilidad endoshy

crina y para [a producci6n de ciclos anovulatorias

en geshy

nital y mamario y en pacientes con antecedentes tromboflebishyticos insuficiencia hepatica sangrado vaginal de etiologia des-

CONTRAINDICACIONES Coniraindicado carcinoma

conocida sensibilidad al medicamento

REACCIONES SECUNDARIAS Pued producir sangrado intermenstrual nluseas cambios de fluid menstrual dismeshynorrea amenorrea durante y despues del iratamiento candishy

diasis vaginal cistitis nausea vomito calambres abdominales

cloasma o melasma efterna multiforme errtema nodaso e

urticaria edema angioneurotico rash acnehirsutismo pruritaalooecia cefaie7 migraia mareas depresion nerviosismo inshy

sornnolenca y fatiga aumento o disminuci6n de peso edema camt)os at a libido

DOSIS Una ampolleta IM profunda entre el 7o y 10o

dias desoues de inicada [a mensiruaci6n

PRESENTACION Cala con una ampolleta de I ml Antes de prescribir consure la pig VIII leyendas I y 2

Reg Num 87414 S S FARMACOS CONTINENTALES S A

ue Av San Ignacio Num 1831 72570 Puenla Pue

328 ENF ENC04481CL 0-C a nti nU 4

CONTRAINOICACIONES Hasta anora no se conocen

PRECAUCIONES Ert ndros eretitscas ante tudo tras admiCshynistrac16n de dosis elevadas puede producirse a veces un au-

mento no deseado de la impulsividad qua puede controlarse reduciendo la dosis Para evitar tra-sornos del suerfo en nishy

os la dosis uitima del dia no debe administrarse a horas avanzadas de la tarde a por la noche

REACCIONES SECUNDARIAS Raramente en caso de hiper-

sensibildad indadual pueden apaeLer diversas reacciones aler-

gicas esoecialmence cutaneas asi como alteraciones del gusto

que remicen al suspender el ratamienco Los pacrentes con reumacisma articular cronico (artrais reumaroidel son ms pro-pensos baio tratamiento con piritinol a pacocer efecros no deseados en eilos es preciso controlar regularrnente el cuadro hem tico la orina y la funci6n heoatica

INTERACCIONES MEDICAMENTOSAS Hioe-sansibilidad al medicamento

DOSIS- DURACION DEL TRATAMIENTO

Adultos 300-6WC mg diarios reaartioos en 3 comas al dia

Nifias 50-3W0 mg ciarios 1i a 3 cucharaditas seg6n edad

e indicaci6n

Dado quoa l accion se inicia gradualmente el tratamiento

deie durar coma minima de 6 a 8 semanas En enfermedades cr6nicas puede proseguirse el tratamiento durante un periodo mas largo

ENCEPHABOL 200 mg Envasa con 24 grageas ENCEPHAEOL 100 mg Envase con 24 grageas

Frasca con 120 l

Antes do prescibir consulte la pag VIII leyenda 1

Regs Nrns 61495 y 66191 S S

MERCX-MEXICO S A

Calle 5 N6m 7 53370 Naucalpan de Juarez Edo de Mdxico

Marco registrada

E N F A L A C

Vdase Seccidn de

A P R 0 DL IM EN

U C T 0 S TIC IOS SN

M E A J0HNSON

oE MrErXIcaLA DE CV

Calz do Tlaloan Nim Z6 04000 Mexico D F

Marco registrada

E N T E R D NA -Talta[

Taleras ~

Antis6ptico Intestinal

FORMULA Coda TABLETA contiene

OivodtjdrpcaLa 015 g Ftalil-sulfacacamida 020 g Succrnil-sulfatiazol 020 g Tanato de caseina 005 g Pectina cittica 005 g

EAcpience cbp I tableta

INDICACIONES 0ienterias amebianas y bacilares Oiarreas

estivales coitra ulcerativa intecciosa y muccmemoranosa Pro-filaxis zrt pre y postooeratorio intestinal

CONTRAINDICACIONES Concraindicada en Ii constipacion

en personas hiperseisibles a las sulfas a al odo

REACCIONES SECUNOARIAS Puede producir nausea vomito y eruocon cutanea

DOSIS De 1 a 4 canletas tresecs al dia

PRESENTACONES Tuoas de 0 y 00 tabletas

Anrs do Drescnbir consuire a 0aq WkIIevend-1 I

Reg Num 435- S S

LAORATORIOS MANUELL S A 7 n- - -1 - 3 5 73 l

E N T E R O C A R B I N

Comorfrdos

Auxiliar en al traramiento de la amebiasis

FORMULA Cada COMIPRIMIDO condone

Ftallsulfacnazol 0200

Succinilsulfabiazot 0200 g

Diyoaohidrcxiquinoieina 0100

Carbon 0200 3

Metilbroruro de homarooina 0002 3

Exctpiente c I

INOICACijNES En el traramiento de ameoiasis e

nes intestinales causadas par smigelfas y salmonellas CONTRAINDICACIONES Personas hipersensables a las

glaucoma Hipersensibiload al yoco anuria oliguriansushycia hepico y renal displasia meoular embarazos premair reciin nacidos

PRECAUCIONES- Evitesa ingerir bebidas alcohalicas durut el tratamiento

REACCIONES SECUNDARIAS Puece presentarse na- vdmito eruoci6n cutanea y sequedad de boca Ocasionaar- pueden presentarse reaciones par hipersensibilidad a los cushyponentes de [a f6rmula a diarrea transitorra vertigo neuri 4

tia mielo6pcica cefalea fieore sindrome de Stevens-Jonnsun y hepatitis

DOSIS Adultos DOe 2 a 3 comprimidos 3 veces al ca con los alimentos durance 10 dias Nifios de a 6 ao

De Y a i comorimiuo 3 veces al dia durance el ienw

clue indique el medico 6 a 12 aios De ia I comnrnmxJ

3 veces al dia durante el tiemoa qua indique el medico

PRESENTACION Caja con 24 comprimidos

Antes de prescribir consulte la pag VIII leyenda I

Reg NrOm 52215 S S

INDEX DE MEXICO S A

LABORATORIO DE PRODUCTOS MEDICINALES

Fragonard N6m 40 03910 Mxico 0 r

Marca regiscrada

E N T E R 0 C 0 L S I N _ER C LIIN

Suspensidn ingernble

FORMULA Coda AMPOLLETA contiene los siguientV5 g6rmenes muertos

Streptococcus faecalis 10 000 inidl(c EkT1nnna - 20 000 m

wi r

Vehicula cb

vINDICACIONES Vacuna oral Puede asociarse a tOdO

tamiento con anribidtbcos a sulfas

CONTRAINOICACIONES Idiosincrasia a alguno de 1

componences de Ia 16rmula

REACCIONES SECUNDARIAS Estrefiimiento ocasoarJ

DOSIS De 3 a 6 ampolletas par las maiianas mediJ t

antes del desauno durance 5 dias Repetir el tra J v I mes y 3 meses aepubs

Coma vacuna oral 3 amoolletas antes de coda durance 10 dlas y I ampolleta diarna durance 30 a 60 -

PRESENTACION Caja con 6 Ampulas bebibles de 5

ntes de prescnbir consulte la pJ g VI eyendJ7

Reg Nim 82S06 S S LABORATORIOS DR ZAPATA S A

Una empresa del GRUPO PHARMA

Antigua Av de las Granjas N6m 625 02520 Mexic0- 0

Marca registrada

-1 1 Los laboraroras farmacoudicos acen un Ioable esuerzo 0o0 1 f

a H Cuerpo Wdico mericano sta ocra cenihca Les vedit1

tan amaOes de xor-sar su agra Cecrrtenro j esros aaorarout itmenalrsa cjCitujd jr ntesrji e coorcon3ne n f0rrrji J t-

verz onca y cOar-cler3 acre us roduccS v

5

bull-5 Adultos 4 taletas al d (12 g) en una sofa

dsar por 2 03dias

t-- o 60 mgkg de peso len una sofa tama die 2 6 3 dias

b-asis hep~tic Adultos 4 tablotas al dia (2 g) diaria por 3 a 5 dias- sofao 60tomamgkg de psen una sol oma diara

5 0i a0 peso3 a 5 das

S y tricomoniasis Adultos 4 taait s al dia

G- len una sofa ioma un sulo dial

reco-Nios 50 a 75 mgkg en una toma al dia Se oa tratamiento simuftneoel nes pot anaerobios Aduftos inicialmente 4 ta-

as (2 g) en una sofa toma el primer dia y se conti-racon 2 tailetas 11g) en una sofa toma por 5 0 6 dias

4 tableshydo colon Adultosdo cirugiapreoeratorio en una sofa toma 12 horas antes de la cirugia So

sofa vez desoues de -imienda tomar las tabletas una amentos de preferencia en la noche

p-tsENTACION Caja con 8 tabletas de 500 mg de prescrbir consure le peg VIII Ioenda 2

Reg Nim 86516 S S Hecho en M~xico port

LABORATORIOS GROSSMAN S A Segn f6rmula de

Armour Pharmaceutical Co

ie Tialpan NCm 2021 04040 Mtxica 0 F registrada

E S T R E P T 0 M C N A S Solucidn inyectable Lakeside

Auxiliar on al tratamiento do algunas infecciones

1 oducidas por g6rmenes grampositivos y gramnegativos

Cada FRASCO AMPULA contiene 10 g deFORMULA tpiomcina base coma sulfato Diluente 2 ml

INDICACIONES En infecciones producidas por g~rmenes los rubercuiosos siemshyx-nnegatrvos Tuberculosis En procesos

pv oeoe asociarSe con aiguno d_ Ids aniifiniccs especificosES~ a sal

renales lesi6n del Vill par craneal CONTRAINDICACIONES Idiosincrasia Ia padecimien-

REACCiONES SECUNDARIAS Lesi6n vestibular insuficien-o renal discrasias sanguineas rash

DOSIS Adultos En lesionfs tubenulnsas deberf iniciarse el tratashy

--n con I g diaro haste que a juicio del medico se re--pot semana la doss_

NiAos 20 mg pot kg de peso en las mismas condiciones ow en el adulto

PRESENTACION Caja con 1 frasco hmpula

Antes de prescuibir consulte I pag VII leyenda 5

Req Num 47876 S S

Hecho en Mexico port

FARMACEUTICOS LAKESIDE S A= do C V

Via Isidro Fabela Nim 1536 Norte

50030 Toluca do Lerdo Edo de Mex

MLaca registrada

E S T R E S U L F A _N N ENrA

CJosias y s onsomnio

Antisbptico intestinal y anticolin~rgico

- SUSPENSIONFORMULAS CAPSULAS Cara ctpsula Cada 100 ml

contione contienen

de estrepomicina) g---ente a 75 mg 150 --e n-oao75mc1n0base

- tioC zna base 2-m mg 400 g

EST 341

Metibromuro de pioenshyzolato 2 mg 25 m

Caolin 20 g

Pectina 100 g Una cucharadita de 5 ml contiene 200 mg de sulfaaiacina y

75 mg de sulfato de estreptomicina

DESCRIPCION Es una combinaci6n de antibidtico de amplio espectro con un quimioterapico sintetco muy efecivo contra los cuadros diarreicos comunes y corrientes con una

actividad antimicrobiana muy efectiva y con muy baja toxicicad

en tratamiento de diarreas pot Esshy

cherichia coli Saimonellas Shigellas a pot germenes no esshypecificos

CONTRAINDICACIONES Alergia a sulfamidas insuficiencia

INDICACIONES Util el

renal yo hepatica Glaucoma hipertrofia prostitica y pil6rica

indicadas porPRECAUCIONES Debe utilizarse a las dosis no mas de 5 dias Se deberan evitar las bebidas alcoh6licas

REACCIONES SECUNDARIAS En dosis elevadas puede

producir cristaluria nefrosis hepatitis toxica hematuria

USO DURANTE EL EMBARAZO Y LACTANCIA Se puede utilizar dur~nte el emoarazo y lactancia a las dosis inshy

dicadas y bajo vigilancia medica

VIA DE ADMINISTRACION Oral DOSIS

Adulto A juicio del m~dico Se sugieren de 2 a 4 cApshy

sulas cada 4 horas dependiendo del peso Nifios cuchashyradita de suspensi6n por kg de peso al dia fraccionando ladosis y administrandola cada 4 hores o la que el medico seshyfiale

Duraci6n minima del tratamiento Durante 5 dias

PRESENTACIONES CApsulas Caja con 20 Susponsi6n Caja con frasco de 60

ml y cucharilla dosificadora de 5 ml

Antes de prescribir consulte la pig VIII leyenda 2

Regs Nms 8403 y 84174 S S

LABORATORIOS INFAN S A

Calzada de Tlalpan N~m 4515 14050 Mexico D F

TR 0 N0 L FES TA 0ONO0L-F

Solucion inyectable

Estr6geno progestacional FORMULA Cada AMPOLLETA do 1 ml condone

Progesterona 50 mg

3 mg Aceite de sesamo cbp 1 mlBenzoato de estradiol

INOICACIONES Irregularidades del ciclo dismenorrea enshydometriosis masiodinia tensidn premenstrual esterilidad endoshy

crina y para [a producci6n de ciclos anovulatorias

en geshy

nital y mamario y en pacientes con antecedentes tromboflebishyticos insuficiencia hepatica sangrado vaginal de etiologia des-

CONTRAINDICACIONES Coniraindicado carcinoma

conocida sensibilidad al medicamento

REACCIONES SECUNDARIAS Pued producir sangrado intermenstrual nluseas cambios de fluid menstrual dismeshynorrea amenorrea durante y despues del iratamiento candishy

diasis vaginal cistitis nausea vomito calambres abdominales

cloasma o melasma efterna multiforme errtema nodaso e

urticaria edema angioneurotico rash acnehirsutismo pruritaalooecia cefaie7 migraia mareas depresion nerviosismo inshy

sornnolenca y fatiga aumento o disminuci6n de peso edema camt)os at a libido

DOSIS Una ampolleta IM profunda entre el 7o y 10o

dias desoues de inicada [a mensiruaci6n

PRESENTACION Cala con una ampolleta de I ml Antes de prescribir consure la pig VIII leyendas I y 2

Reg Num 87414 S S FARMACOS CONTINENTALES S A

ue Av San Ignacio Num 1831 72570 Puenla Pue

5

bull-5 Adultos 4 taletas al d (12 g) en una sofa

dsar por 2 03dias

t-- o 60 mgkg de peso len una sofa tama die 2 6 3 dias

b-asis hep~tic Adultos 4 tablotas al dia (2 g) diaria por 3 a 5 dias- sofao 60tomamgkg de psen una sol oma diara

5 0i a0 peso3 a 5 das

S y tricomoniasis Adultos 4 taait s al dia

G- len una sofa ioma un sulo dial

reco-Nios 50 a 75 mgkg en una toma al dia Se oa tratamiento simuftneoel nes pot anaerobios Aduftos inicialmente 4 ta-

as (2 g) en una sofa toma el primer dia y se conti-racon 2 tailetas 11g) en una sofa toma por 5 0 6 dias

4 tableshydo colon Adultosdo cirugiapreoeratorio en una sofa toma 12 horas antes de la cirugia So

sofa vez desoues de -imienda tomar las tabletas una amentos de preferencia en la noche

p-tsENTACION Caja con 8 tabletas de 500 mg de prescrbir consure le peg VIII Ioenda 2

Reg Nim 86516 S S Hecho en M~xico port

LABORATORIOS GROSSMAN S A Segn f6rmula de

Armour Pharmaceutical Co

ie Tialpan NCm 2021 04040 Mtxica 0 F registrada

E S T R E P T 0 M C N A S Solucidn inyectable Lakeside

Auxiliar on al tratamiento do algunas infecciones

1 oducidas por g6rmenes grampositivos y gramnegativos

Cada FRASCO AMPULA contiene 10 g deFORMULA tpiomcina base coma sulfato Diluente 2 ml

INDICACIONES En infecciones producidas por g~rmenes los rubercuiosos siemshyx-nnegatrvos Tuberculosis En procesos

pv oeoe asociarSe con aiguno d_ Ids aniifiniccs especificosES~ a sal

renales lesi6n del Vill par craneal CONTRAINDICACIONES Idiosincrasia Ia padecimien-

REACCiONES SECUNDARIAS Lesi6n vestibular insuficien-o renal discrasias sanguineas rash

DOSIS Adultos En lesionfs tubenulnsas deberf iniciarse el tratashy

--n con I g diaro haste que a juicio del medico se re--pot semana la doss_

NiAos 20 mg pot kg de peso en las mismas condiciones ow en el adulto

PRESENTACION Caja con 1 frasco hmpula

Antes de prescuibir consulte I pag VII leyenda 5

Req Num 47876 S S

Hecho en Mexico port

FARMACEUTICOS LAKESIDE S A= do C V

Via Isidro Fabela Nim 1536 Norte

50030 Toluca do Lerdo Edo de Mex

MLaca registrada

E S T R E S U L F A _N N ENrA

CJosias y s onsomnio

Antisbptico intestinal y anticolin~rgico

- SUSPENSIONFORMULAS CAPSULAS Cara ctpsula Cada 100 ml

contione contienen

de estrepomicina) g---ente a 75 mg 150 --e n-oao75mc1n0base

- tioC zna base 2-m mg 400 g

EST 341

Metibromuro de pioenshyzolato 2 mg 25 m

Caolin 20 g

Pectina 100 g Una cucharadita de 5 ml contiene 200 mg de sulfaaiacina y

75 mg de sulfato de estreptomicina

DESCRIPCION Es una combinaci6n de antibidtico de amplio espectro con un quimioterapico sintetco muy efecivo contra los cuadros diarreicos comunes y corrientes con una

actividad antimicrobiana muy efectiva y con muy baja toxicicad

en tratamiento de diarreas pot Esshy

cherichia coli Saimonellas Shigellas a pot germenes no esshypecificos

CONTRAINDICACIONES Alergia a sulfamidas insuficiencia

INDICACIONES Util el

renal yo hepatica Glaucoma hipertrofia prostitica y pil6rica

indicadas porPRECAUCIONES Debe utilizarse a las dosis no mas de 5 dias Se deberan evitar las bebidas alcoh6licas

REACCIONES SECUNDARIAS En dosis elevadas puede

producir cristaluria nefrosis hepatitis toxica hematuria

USO DURANTE EL EMBARAZO Y LACTANCIA Se puede utilizar dur~nte el emoarazo y lactancia a las dosis inshy

dicadas y bajo vigilancia medica

VIA DE ADMINISTRACION Oral DOSIS

Adulto A juicio del m~dico Se sugieren de 2 a 4 cApshy

sulas cada 4 horas dependiendo del peso Nifios cuchashyradita de suspensi6n por kg de peso al dia fraccionando ladosis y administrandola cada 4 hores o la que el medico seshyfiale

Duraci6n minima del tratamiento Durante 5 dias

PRESENTACIONES CApsulas Caja con 20 Susponsi6n Caja con frasco de 60

ml y cucharilla dosificadora de 5 ml

Antes de prescribir consulte la pig VIII leyenda 2

Regs Nms 8403 y 84174 S S

LABORATORIOS INFAN S A

Calzada de Tlalpan N~m 4515 14050 Mexico D F

TR 0 N0 L FES TA 0ONO0L-F

Solucion inyectable

Estr6geno progestacional FORMULA Cada AMPOLLETA do 1 ml condone

Progesterona 50 mg

3 mg Aceite de sesamo cbp 1 mlBenzoato de estradiol

INOICACIONES Irregularidades del ciclo dismenorrea enshydometriosis masiodinia tensidn premenstrual esterilidad endoshy

crina y para [a producci6n de ciclos anovulatorias

en geshy

nital y mamario y en pacientes con antecedentes tromboflebishyticos insuficiencia hepatica sangrado vaginal de etiologia des-

CONTRAINDICACIONES Coniraindicado carcinoma

conocida sensibilidad al medicamento

REACCIONES SECUNDARIAS Pued producir sangrado intermenstrual nluseas cambios de fluid menstrual dismeshynorrea amenorrea durante y despues del iratamiento candishy

diasis vaginal cistitis nausea vomito calambres abdominales

cloasma o melasma efterna multiforme errtema nodaso e

urticaria edema angioneurotico rash acnehirsutismo pruritaalooecia cefaie7 migraia mareas depresion nerviosismo inshy

sornnolenca y fatiga aumento o disminuci6n de peso edema camt)os at a libido

DOSIS Una ampolleta IM profunda entre el 7o y 10o

dias desoues de inicada [a mensiruaci6n

PRESENTACION Cala con una ampolleta de I ml Antes de prescribir consure la pig VIII leyendas I y 2

Reg Num 87414 S S FARMACOS CONTINENTALES S A

ue Av San Ignacio Num 1831 72570 Puenla Pue

y ADMINISTRACION i o 2 cucharadltas cada dos o tres horas

o 1 cucharadita cada tres horas _Znento debera administrarse hasta 24 horas des a d es apa ric id n de lo s s in to m a s

S~EA CI ON FrcFra scode 240 imde 24 0 ml Ec p oeTACIONn

ceeprescribir consute la pig V111Jeyenda 1 Reg Num 63956 S S

R sQUIBB amp SONS DE MEXICO S A de C V Nim 1267 01040 Mdxico D F-

Lindividuos

F A C E T N -D Comprimidos

Amebicida

FORMULA Cada COMPRIMIDO contiene Diyodooxiquishy- 015 g Italilsulfacetamida 040 g metilbromuro de -onattovina 0001 g excitpiente cbp un comprimido con o redio de 080 g

PROPIEDADES Ccmbinaci6n medicamentos unade cn alta zoacioad para inhibit el desarrollo de gran cantidad de

-croorganismos intestinales que pueden en ciertas condicio-rne favorecer el desarrollo de la Endamoeba histolytica 0 tc provocar infecciones secundarias La diyodooxiquinolina

un amebicida de gran potencia que sus efectos aune los tcteriostaticos de la ftalilsulfacetamida ya que se ha corn-

Dvcoaoo que inhibiendo el desarrollo de la flora intestinal de4ocacidn las formas m~viles de la Endamoeba histolytica

tvnoien disminuyen intestinal yCCe aguda cnca

INDICACIONES Amebiasisrtei jsaguda disenteria bzcilarinetnlc 0era u gd rnc

CC)RAINDICACONES Hiertiroidismo En todos aquellos riduas que han mostrado hipersensibilidad a cualquiera de componentes

PRECAUCIONES DURANTE EL EMBARAZO No se ha ntaoiecido ninguna reacci~n adversa de los principies activas 3 ane el embarazo REACCIONES SECUNDARIAS Escalofrios dermatitts irrita-REonanal disconfor abdominal cecalea

USO DURANTE EL EMBARAZO Y LACTANCIA A crite-10del meico

COSIS Y DURACION DEL TRATAMIENTO Tomar 2 6 3rtrimiacos tres veces al Cia durante 20 dias

Alimentos que deben evitarse y dietas especiales Se evitar la ingestion do beoidas alcon0licas y alimentos

ranl S PRESENTACION Frasco de 20 comprimidos

Atres de pescribir consulte la Dg Viii evenia 2

Reg Nm 45751 S S

LABORATORIIOS IFUSA S A

--ana ibm 20-Ja C64 703Mexico 0 F7 registraca

FAC 351 F A C E T N D

Amebicida bactenosttico intestinal antidiarreico - _

FORMULA Cada 100 ml contienen

Diyodooxiquinolina 300 g eriall-uracey a z 600 gMetilbromiiro de homatropina 1002 g

Caolin oloidal 1000 gPectina 100 gVehiculo cbp 100 ml

INDICACIONES Conio auxiliar en el tratamiento de los esshytoas disent~ricos amebianos sindromes diarreicos inesoecificos ldiarea infantil diarrea estival) enteritis aguda colitis ulcerativa disenteria bacilar

CONTRAINDICACIONES Hipertiroidismo En todos aquellos que han mostrado hipersensibilidad a cualquiera de

sus componentes

PRECAUCIONES DURANTE EL EMBARAZO No se ha establecid ninguna reaccibn adversa de los principios activos durante el embarazo

REACCIONES SECUNDARIAS Escalofrios dermatitis irritacibn anal disconfort abdominal cefalea DOSIS Y DURACION DEL TRATAMIENTO Adultos 2

cucharadi res al durante 20 diasveces dIa Niios Tomar 1 o 2 cucharadas tres veces a) dia durante 20 dlas

Alimentos lue deben evitarse y dietas especiales Se debe evitar ij ingestion de bebidas alcohdlicas y alimentos irritantes

PRESENTACION Frasco conteniendo 100 ml Antes de prescibir consulte la pig VVII Ieyenda 2

Reg N 46591 S S

LABORATORIOS IFUSA S A Lorenzanj Nim 20 06470 Mdxico D FMarca fegistrada

F A C C A M

Cpsulas

Antirreumticoantiinflamatorioanag sico no esteroic

FORMULA Piroxicam 20 mg Excipiente cbp 1 caasula Piroxicam 10 mg Excipiente cbp 1 cpsula

DESCRIPCION FACICAM un y potente antirreumatishyes nuevo co-antiinflamatorio-analgesico no esteroide con estruciura quimicadiferente Posee excelente efectividad y es bien tolerado y se puede adminisirar cadad d ii t ar c d 244 horash r sCaracteristicas farmacol6gicas Adecuada absorcion porvia oral Concentraciones plasmaticas proporcionales a las doshysis sin acumulacion Vida media superior a 36 horas Io quepermite dosis nica cada 24 horas Adecuadas concentraciones

-n Ilquido sinovial Sin interacciones farmacocintticas con --otros antiinflamatorios anti~cidos o anticoagulantes Inhibe la

sintesis de prostaglandinas Impide la agregacion plaquetaria Innibe la fagocitosis y liberacion de enzimas lisosomicasSuprime la migracion de polimorfonucleares al sitio inflamado

Eficacia clinica Alivio del dolor en las arniculaciones enmovimiento Reduccin la matutina Reducci6n dela tumetaccidn Menor de rigidezlimitacion del movimiento Aumento en la fuerza de prension srninucion en el tiemoo reluerido paracamnar

INDICACIONES Enfermedades reum~ticas articulates Anritis reumalo de espondlitis anquilosante artritis gotosa asshyteoartritis

Enfernedades reumAticas extraarticulares Fibrositis re

riartrils escauulohumeral lhombro doloroso bursitis tendosinovitis reumatismos muscuiares Afecciones musculoesqueleticas Traumaticas Y cenortivas cl tusiones esguinces luxaciones fracturas cesgarrs musculares

ADMINISTRACION ORAL Dosificaci6r20 mg al doa En nie--anes Una c3osuia de Lmusciesueie-icas aguiias se

IMO 457

I M 0 D U M PRESENTACION Solucion Infantil Frasco 60 ml con cuciarsta yraauaca a 5 mi Caoa 5 mi = 1 mg 1 ml

J A N S S E N rg Clorhiarato de loperamida

Grageas Antes ae prescrt consulte la pag VII endas I y 2

Antidiarreico Reg 46m 83326 S S JANSSEN FARMACEUTICA S A de C V

FORMULA GRAGEAS Cada una contiene Clornidralu de Planta Carr Fed Mexico-Puebla km 995 r 4mida 2 mag excipiente cb p Oficinas Canoa -46m 79 01090 Mexico D F

INOICACIONES IMODIUM Grageas esta inoic300 en el Marca registrada trol de las diarreas agudas y cronicas y del tiempo del JVESTIGA DESCUBRE Y DESARROLLA

intestinal en parientes aesnues de ileustomias coilao ~itrab tnWeecttirez - - _

CONTRAINDICACIONES Cuanoo debe evwtalsa cualquier M 0 T 0 F T E N 0 A L 05 onstipanteo cuando la func16n hepatica es deficiente

Salucidn oftalnicaREACCIONES SECUNDARIAS En algunos pacentes con ulcerativa aguca los medicamentos que inhiben ]a mot- Antiglaucomatoso

i=ntestinal o retrasan el tiempo del transito intestinal ~n precipitar el megacolon toxico coma hepatico midria- COMPOSICION Cada 100 ml contienen

jsnea cefale aumento de la presion intraocular taqui- Maleato de timolol equivalente a 0500 g rya rash disuria y retenci6n aguda de orina de timolol

Adultos y nihos mayores de 12 aios Vehiculo cbp 100000 mlDOSIFICACION Darreas agudas 2 grigeas al iniciar el traiamiento y 1 gra- INDICACIONES Glaucoma crtnico de bngulo abierto glau

a espues de cada evacuaci6n diarreica sin excederse de 8 coma af~quico glaucoma secundario hiperiension intraocular y v geas en las 24 horas Suspender el tratamiento al Ilegar al glaucoma de hngulo estrecho

losde cntrolsintomas CONTRAINDICACIONES Broncoescasmo asma bronquialDiarreas cr6nicas Comenzar con 2 Srageas y lar una neuroopatia obstructiva cr6nica insuficiencia cardiaca no conshya9ea desPu~s de cada evacuacion hasta controlar la fre- troltda hipersensibilidad a fos componentes de la formula cncia y consistencia de las heces Di-minuir gradualmente la

hasta al 6ptimo paciente conhs Ilegar control del PRECAUCIONES Debe usarse cuidado en bradicardia El empleo de esta medicamento durante el emoaazo queda sinusal cnoque cardiogenico diabetes meilrtus carditpatas emshy

ro la responsaoilidad del medico No se deje al alcance de baraza y niAos menores de 12 alias ct nihos No se administre a niiios menotes de 2 args REACCIONES SECUNDARIAS- Irritacion ocular conjuntivits

PRESENTACION Caja con 12 grageas de 2 rng vision borrosa erupciones cutaneas lacalhzadas y generalizadas V111Ieenda 2 urticaria

Antes de prescribir consulte a pig Efectos sist~micos Bradirritmia hipotension sincope bronco-

Reg Nurm 83335 S S espasmo insuficiencia respiraxoria y cardiaca ocasionalmente

JANSSEN FARMACEUTICA S A de C V cefalea sequedad de boca nusea mareos fatiga somnolen

Planta Carr Fed Mexico-Puebla km 995 cia palpitaciones e hipotensi~n

C4cnas Canoa N~n 79 01090 Mexico D F DOSIS Y ADMINISTRACION Una gota dos veces al dia de soluci6n al 025 si la respuesia no es adecuada usar

Marca registrada la concentracin del 050 a la misma dosis INVESTIGA DESCUBRE Y DESARROLLA PRESENTACION Frasco gotero con 5 ml

Antes de prescribir consulte la pig V1II leyenda 2

M O D UM Reg Num 042M84 S S JA N S S E N LABORATORIOS SOPHIA S A de C V

bull olucidnifaj Hidalgo Nm 7Z8 44290 Guadalajara Jal

Antidiarreico - M 0 T 0 F T E NI 0 A L 025 FORMULA Cada 100 ml contienen Clornidrato de lopeshy

rmida 20 rag vehiculo cbp Solucidn oftimca

INDICACIONES IMOCDIUM solucidin infannl estA indicado Antiglaucomatoso e el control de las diarreas agudas en nihos A

CONTRAINDICACIONES Cuanoo debe eviarse cualquier COMPOSICION Cada 100 ml conienen P-co constzipante Cuando la funcion hepatica es dleficiente Maleato de timolol equivalente a 025 g

de timolol PRECAUCIONES No se admintstre este medicamento a ni- Vehiculo cbp 10000 ml

has menores de dos aspos INDICACIONES Glaucoma crtnico de 6ngulo abierto glauUna sobredoss de este medicamento puede ocasianar una coma afaquico glaucoma secuncario hipertensi)n intraocular y

Orfesion resoirataria grave si est) sucede el paciente denera glaucoma de Angulo estrecho 1- nospitalizacio inmediatamente CONTRAINDICACIONES 8roncoespasmo asma bronquial

REACCIONES SECUNDARIAS En algunos pacentes con neumotratla obstruciva cronica insufiioencia cardiaca no conshyulrerativa aguda los medicamenios que inhiben la moti- trolada hipersernsibilidad a los componentes ae la formuia nitestinal o retrasan el tiemoo del transito intestinal pue- PRECAUCIONES Dee usarse con cudaoc en nradic3rdia

ecpiotas el meqacolon oxco coma he 3aco m ariasis sinusal coque cardiogenico diaees meiitus cardioatas = cefalea aiimento de la presion intraocular taquicarcia

Cisuria y retencion aguda de arna emoarazo y nios menotes ae- 12 afts

V1A DE ADMINISTRACION Oral REACCIONES SECUNDARIAS lrritaion ocular conjuntvins vsiln borrosa eruacones cutaneds locaOizaas y gnoraizdics

DOSIFICACION Diarrea aguda Una cucwataa de soU ucaa nhi 5 mi por caca 10 g ae pto 2 c -- eS 3 Efecios sistemicos 9adrrmia nscenson oncoe brono

I mg- g pedod dl esoasmo irisuficncia ooa V 3foiaca ocacnalmenie -O IdM no di11legal d- contlU de t mii cefw 3 seaueaac de oca rausea rr3recs fatgo somnoien

- - 3 =5 S rS3C2 ca oaictaciones e icere sion

192 LAC LAYMETACY( CM ESTO-Can IIn l

Acido asctraico 50 mg Carconato de calco 15 mg

LABYMETACYN COMPUESTO de accbon anoflogistica ani piretica analgesica y relalante del musculo estnado se deoe a la asociaci6n de dos frmacos antirreumaticos la indometacina (no esteroidel y la dexametasona (hormonal) f el carisopro dol relaiance muscular la presenca en la f6rmula de carbo nato calcico avuda a prevenir la irntaci6n gasznca quf pooria producir la inaometacina

INDICACIONES LABYMETACYN COMPUESTO estA indicado en reumatismo agudo subagudo y esoecialmente en las forrnas articulares y musculares en goae en- sus Civersas formas en neuns polineuritis neuralgias y afecciones dodrosas ocasiona das par las inflamaciones do los tejiios

CONTRAINDICACIONES Niecs embarazo o lacrancia 01 cera pephica acdva historia recurrente do lesiones gastrointes-tina(es sensibilidad a la indomeracona estados convulsivospsicasis grnven (

PRECAUCIONES En preencia de trastrns p

epiiepsia parkinsonismo infecciones No conducir veniculos de motor durante el tratamiento Deberi aoministrarsa con alimen ros leche a un antidcido Si se presenta c-falea y 6sta persiste suspendase el tratamienco asi coma si ocurre sangrado intestR1 nal Usese con mayor precauci6n en los ancianos

REACCIONES SECUNDARIAS Cefalea v~rdgo confusi6n mental somnolencia y otras alteraciones psiquicas NAusea anorexia v6mito diarrea Ictericid y hepatitis Prurito urticaria Leucopenia puroura anemias aplsica y hemolitica tromboci topenia Tinnitus y sordera Cara de luna aumento de peso y apecico

DOSIS LABYMETACN COMPUESTO so administra por via oral aplicando la dosis a cada paciente de acuerdo con la to-lerancia y respuesta terapdudca

Oasis inicial Una cipsula 2 6 3 veces al dia deaendiendo de la intensidad del dolor an gota 6 cJosulas diarias recarshytidas en 3 tomas hasta la remisi6n de todos los sintomss

PRESENTACION Caja con 20 cipsulas

Antes de prescribi consulte la pag VIII eyenda 2 Reg Ncm 70015 S S

LABYS S A Av Popocatepe NOm 167 033 Mexico D F

PR0DUCTO NUEVO

L A C T C A R E T

Crema quida

Emollente humectante

FORMULA Cada 100 ml contienen

Acido lIActico 5 g Pirrolidona - carboxilato do sodio 25 g Excipiente cbp 100 ml

INDICACIONES Es una crema especialmente formulada para condiciones carac-erizadas pot resequedad de la piel

CONTRAINDICACIONES So desconocen hasta [a fecna

REACCIONES SECUNDARIAS Se desconocen haste la fecna

DOSIS Y MODO DE EMPLEO Desou6s de lavar la cail y manes rese suavemente dos veces al dia pot la maiana pot la nocne hasta qua so haya absorbido toalmen(e Ourad el tiemoo que sea necesario

PRESENTACION Frasco de plis-ico con 1-0 ml

Antes de prescbr r consulte Ia oag VIl leyenda 2 Reg Num S6gTamp S S

Hecho en Mxico 0or

LABORATORIOS ANE( S A

Av 1 Ncm 61 San Pedrn de Ins Pinos 000 xico 0 F

Balo licenca excusiva de -Tir- i Rr)R-1TORIFS- INC

L A C T O G L A N D N

Grageas

Galactgeno

FORMULA Cada GRAGEA contiene 01 g de ex- mama lequivaience a I g de mama frescal 01 g Ce eshyde olacenta (equivalence a 1 g de olacenta frezica - vicamina Bi 25 mg de tweagloiuiina

INOICACIONES Hipogalactia

CONTRAINDICACIONES Insuticiencia adrenal no shypacentes hioersensioles a algun componence de la t6rmrj

RACCIONES SECUNDARIAS Ocasionalmente na

vdmi(o y eruccion cuanea -

POSOLOGIA 1 a 2 grageas 3 veces al dfa Incar tratamiento t3n pronto so oOserve la insuficiencia dec

el resultado deseacoprolongarlo hasta que se obtenga

PRESENTACION Frasco con 50 grageas Antes de prescribir consulte a pig VIII eyenda

Reg Nm 13-2 S S

LABORATORIOS HORMONA S A do C V

Blvd M Avila Camacho NUm 470 San Andres Ae-z 53500 Naucalpan Edo da Mxico

MarCas registradas

L A C T O P E C T I N -611

usenin Astringents intesdnal opard rratamiUdo

ndiarrea -

FORMULA Hecha la mezcla cada 100 ml contienen a d 6

Lacolcitl os Actdfil o ofL1 za as Polvo de opto (al 10 de morfina) 0C00 -C 0 Pectina 10C a W iniculo cbp 100 -

ACCION LACTOPECTIN detiene la diarrea evita la de- dratacion calma el dolor y resiablece la flora intestinal

INDICACIONES Qiarreas agudas do cualquier etiloagiaLACTOPECTIN suele suspender la diarrea desoues de

primeras dosis par Ia general no requiere administrarsd 00 mas do 24 6 48 iuras Una vez controlada la diarrea 9 1 necesario seguir administrando el antimicrociano se Ecuacshyadrnistrese simultAneamente Lactovita a Lactovita S Pec- = -lacobacilos anabioticorresistentes- para conservar la 9

tesonal expuesta a la destrucci6n par Ia teraca andmicrcoisr6

CONTRAINDICACIONES Ob3truccion intestinal REACCIONES SECUNDARIAS A la dosis y en lasn-

ciones recomendadas las reacciones secundarias son muv ras sin embargo dosis muy elevadas poirian producirr efecos indeseables de los Olaiceos

POSOLOGIA Niiios monores do 1 aia z cucharadita (25 ml) n-

mente y luego Yz cucharadita desoues de coda evac jccentr Maximo 8 medias cucnaraditas en 12 haras

Nios mayores do 1 arjo I a 2 cucharaditas (5 a 0 descucs ae cab evacuacion Maxima 8 cucnaraits horas

Adultos I a 2 cucnaradas 115 a 30 ml) descues de evacJaccn

PRESENTACON Frasco con 0 ml El fresco n poivo oara reconstituir la susoension agregando ague

la serial marcada en la ePicueta

Antes dorescnbir consuirp t aq evendJ

Regs Nums 87PJYJ 1 74170 S S

ANDRE BIGAUX S A Av cenro tirra Tortes um 25 33r

0 T I L E N N F ANTI L

Solucdn

Antidiarreico

FORMULA Cada 100 ml contionon -era]da 20 mg centuo C 100 ml

Cjda cucharadita de 5 ml contiene 1 mg de clorhidrato

oeramida Un ml contiene 02 mg de clorhidrato de pT3-ida

I[ICACIONES Diarreas agudas

CONTRAINDICACIONES Constipacidn atoia intestinalintestinal Diarreas infecciosa a amebiana

cAUCIONES No debe administrarse par tiemo prolon ued deesDratr~agraeseis Unaoatinarunadepesin~s anos- No se administre a niios menores

-5s5 puede ocasionar una depresiin respiratorla grave

L rsucede el paciente dedera ser hospitalizaa inmedliata- mpleo de este medicamento urante el embarazo

lac-ancia queda bajo la responsabilidad del medico

REACCIONES SECUNDARIAS Puede precipitar el mega-- h toxico coma heptico Midriasis disrea cefalea ta-

3dia rash disuria retencion aguda de orina

DOSIS Una cucharodita de 5 ml par cada 10 kg de peso

3 veces 31 dia (01 mgkg de peso sin paso de 8 mg horas)

Sszender el tratamiento a) llegar al control de os sinto--z Ajusflarse a las dosis indicadas-_sAjusarsdsis andiadasls

pRESENTACION Frasco con 60 ml con cucharadita de 5 mlReg Ntam 0034M79 S S 003a 2d Reb csepg VIISPlanta

4n te s d e p rescr b ir c ons ulte la p ig V 11 ley e nd a 2

LABORATORIOS LIOMONT S A de C V

- e Ma Olloqui Ntim 28 03100 Mkico D F - arca registrada

J A N S S E N Tabletas

Gastrocinitico y antiom~tico

FORMULA Cada TABLETA cantiene Domperidona 10 excipiente cbp

DEFINICION La sustancia activa de MOTILIUM deg es una s-tesis original de los LABORATORIOS JANSSEN FARMA U-TICA (Domperidona R 33812 El mecanismo de acci6n de YTLIUM se basa en su ac-ividad bloqueadora doaminica - l+eica

Esudios farmacologicos en vivo e in vitro han mostrado deg Ze ai MOTILIUM aumenta la tonicicad del esinter esofgico

r-o con Io que evita el reflUlo gastroescf~gico b) MOTI-deg

restablece la funcion gasnca normal c) MOTILIUM no -cofca La secrecion g~strica

pur el reflujo gs-INDICACIONES al Molestias ocasionadaslais ()omo pirosis regurgitaciones y ardor en el abdtomnen

b) Molestias relacionadas con un mal tuncionamiento-T

fnco tales como flatulencia y sensacion de plenitud desoues as comidas nauseas 0 votreto

CONTRAINDICACIONES No conocidas hasia el momento conocen incomoatibilidades con otras sustancias eceoto

- i cue puecen innibir los efecos de MOTI-Otcclinergicoi -

emoleo de este medicamento durante el emrarazo oueCa desoonsaPicaddel meoico

REACCIONES SECUNDARIAS Se han eoonaao casos ats e nt o

-- C- celalea comcos y enioleclms facial

bullSIS Y ADMINISTRACION Adultus Ocs aoJetas 3 veces a1 30 ml11LIC antes ce as co-cas So es CE0sao sa

-L ser trmaca de nue-o a -es ce x

-SENTACON Cala on 30 tanoetas ce 11 -g

MOT 579

M 0 T I L I U M J A N S S E N

Suspens ifn gotas

Gastrocindticb y antiembtico

FORMULA Cada ml do las gotas contiene Domperidona 10 mg excipiente cbp

INDICACIONES a) Disfunci6n Zastrointestinal pediatrica como la dispepsia transitoria del lactante b) C6lico regurgitacian nusea y v6mito

CONTRAINDICACIONES No conocidas hasta el momento

No se conocen incompatibilidades con otras sustancias exshyceoto ls anticolinergicos que pueden inr jbir los efeclos de

deg MOTILIUM ADVERTENCIA En vista de cue las funciones metabdlicas

y de 12 barrera hemaienceflica no esi~n totolmente desshy

arrolladas durante los primeros meses de vida MOTILIUM al

igual que cualquier medicamento que se administre a lactantes

menores debera ser usado con cautela y bajo estrecha supershyvisi6n m dica

REACCIONES SECUNDARIAS So han reportado casos aislados de cefalea c6licos y enrojecimient facial

DOSIS Y ADMINISTRACION Una gota (= 03 mg) par

kg de peso corporal 3 veces al dia antes de las comidas

PRESENTACION Suspensi6n gotas Frasco con 20 ml (10 mg par ml)

Antes de prescribr consulte la pig VIII leyenda 2 Flgs N~ms 0042M79 y 0041M79 S S

FAR 79RANSENm M S d SJANSSEN FARMACEUTICA S AA do C V Carr Fed Mexico-Puebla km 995f c n s C a o N m 70 01090 DOficinas Canaa Nm 79 1 9 M~xicoM xi D FF

Marco registrada INVESTIGA DESCUBRE Y DESARROLLA

M O TI VA L Grageas SQUIBB

Tranquilizante y ostabilizador emocional

FORMULA Cada GRAGEA contiene Clorhidrato do nortripshy

tiliria equivalente a 10 mg de la base diclorhidrato de flufenashycina 05 mg excipiente cbp una gragea

INDICACIONES Eficaz tratamiento oe pacientes con ansieshydad ligera a moaerada con ension a agitac6n a ambas con

o sin depresibn coexistente CONTRAINDICACIONES La actividad anticolinergica de la

nonripilina constrtuve una contraindicacidn del uso do la corshybinaciun en pacientes can glaucoma y en pacientes_en quienes se puede esoerar problemas par retencin urinaria La combinashy

cibn fluienacina-nortriotriina no debe set administrada a pacienshytes balO tratamiento con inhibidores de ta MAO

PRECAUCIONES El empleo do este medicamento durante ei emoarazo queda baio la responsabilidad del meoico Se ha informao de discinesias tardias con la terapeutica fenotiacinica

largo plaza por Io cue se sugiere que la administracin dea estos compuestos como tranquilizantes no exceda-a los tes MeSCes

RECCIONES SECUNDARIAS Con la administracin de seauedad de boca constipacibnnoriptiina se ha informado

somnolencia y mareos DOSIS Una gragea tres vecs al dia

PRESENTACJN Frasco de 60 grageas Antes de prescribir nsulte la pag VIII leyenda 2

Reg Num 75601 S S E R SQUIBB amp SONS DE MEXICO S A do C V

Av Revolucion Num 1257 01C-a Mxico 0 F

En ef PECRC4tFIC P-74CTICO PARA EL 1ErIC0 encontrara una a2eis retamp encds mrods tomrnetas soore ijicres ce ret-rena en

18- zrvezg Ct1d0ofdtJoo

)1

IMO 457

I M 0 D U M PRESENTACION Solucion Infantil Frasco 60 ml con cuciarsta yraauaca a 5 mi Caoa 5 mi = 1 mg 1 ml

J A N S S E N rg Clorhiarato de loperamida

Grageas Antes ae prescrt consulte la pag VII endas I y 2

Antidiarreico Reg 46m 83326 S S JANSSEN FARMACEUTICA S A de C V

FORMULA GRAGEAS Cada una contiene Clornidralu de Planta Carr Fed Mexico-Puebla km 995 r 4mida 2 mag excipiente cb p Oficinas Canoa -46m 79 01090 Mexico D F

INOICACIONES IMODIUM Grageas esta inoic300 en el Marca registrada trol de las diarreas agudas y cronicas y del tiempo del JVESTIGA DESCUBRE Y DESARROLLA

intestinal en parientes aesnues de ileustomias coilao ~itrab tnWeecttirez - - _

CONTRAINDICACIONES Cuanoo debe evwtalsa cualquier M 0 T 0 F T E N 0 A L 05 onstipanteo cuando la func16n hepatica es deficiente

Salucidn oftalnicaREACCIONES SECUNDARIAS En algunos pacentes con ulcerativa aguca los medicamentos que inhiben ]a mot- Antiglaucomatoso

i=ntestinal o retrasan el tiempo del transito intestinal ~n precipitar el megacolon toxico coma hepatico midria- COMPOSICION Cada 100 ml contienen

jsnea cefale aumento de la presion intraocular taqui- Maleato de timolol equivalente a 0500 g rya rash disuria y retenci6n aguda de orina de timolol

Adultos y nihos mayores de 12 aios Vehiculo cbp 100000 mlDOSIFICACION Darreas agudas 2 grigeas al iniciar el traiamiento y 1 gra- INDICACIONES Glaucoma crtnico de bngulo abierto glau

a espues de cada evacuaci6n diarreica sin excederse de 8 coma af~quico glaucoma secundario hiperiension intraocular y v geas en las 24 horas Suspender el tratamiento al Ilegar al glaucoma de hngulo estrecho

losde cntrolsintomas CONTRAINDICACIONES Broncoescasmo asma bronquialDiarreas cr6nicas Comenzar con 2 Srageas y lar una neuroopatia obstructiva cr6nica insuficiencia cardiaca no conshya9ea desPu~s de cada evacuacion hasta controlar la fre- troltda hipersensibilidad a fos componentes de la formula cncia y consistencia de las heces Di-minuir gradualmente la

hasta al 6ptimo paciente conhs Ilegar control del PRECAUCIONES Debe usarse cuidado en bradicardia El empleo de esta medicamento durante el emoaazo queda sinusal cnoque cardiogenico diabetes meilrtus carditpatas emshy

ro la responsaoilidad del medico No se deje al alcance de baraza y niAos menores de 12 alias ct nihos No se administre a niiios menotes de 2 args REACCIONES SECUNDARIAS- Irritacion ocular conjuntivits

PRESENTACION Caja con 12 grageas de 2 rng vision borrosa erupciones cutaneas lacalhzadas y generalizadas V111Ieenda 2 urticaria

Antes de prescribir consulte a pig Efectos sist~micos Bradirritmia hipotension sincope bronco-

Reg Nurm 83335 S S espasmo insuficiencia respiraxoria y cardiaca ocasionalmente

JANSSEN FARMACEUTICA S A de C V cefalea sequedad de boca nusea mareos fatiga somnolen

Planta Carr Fed Mexico-Puebla km 995 cia palpitaciones e hipotensi~n

C4cnas Canoa N~n 79 01090 Mexico D F DOSIS Y ADMINISTRACION Una gota dos veces al dia de soluci6n al 025 si la respuesia no es adecuada usar

Marca registrada la concentracin del 050 a la misma dosis INVESTIGA DESCUBRE Y DESARROLLA PRESENTACION Frasco gotero con 5 ml

Antes de prescribir consulte la pig V1II leyenda 2

M O D UM Reg Num 042M84 S S JA N S S E N LABORATORIOS SOPHIA S A de C V

bull olucidnifaj Hidalgo Nm 7Z8 44290 Guadalajara Jal

Antidiarreico - M 0 T 0 F T E NI 0 A L 025 FORMULA Cada 100 ml contienen Clornidrato de lopeshy

rmida 20 rag vehiculo cbp Solucidn oftimca

INDICACIONES IMOCDIUM solucidin infannl estA indicado Antiglaucomatoso e el control de las diarreas agudas en nihos A

CONTRAINDICACIONES Cuanoo debe eviarse cualquier COMPOSICION Cada 100 ml conienen P-co constzipante Cuando la funcion hepatica es dleficiente Maleato de timolol equivalente a 025 g

de timolol PRECAUCIONES No se admintstre este medicamento a ni- Vehiculo cbp 10000 ml

has menores de dos aspos INDICACIONES Glaucoma crtnico de 6ngulo abierto glauUna sobredoss de este medicamento puede ocasianar una coma afaquico glaucoma secuncario hipertensi)n intraocular y

Orfesion resoirataria grave si est) sucede el paciente denera glaucoma de Angulo estrecho 1- nospitalizacio inmediatamente CONTRAINDICACIONES 8roncoespasmo asma bronquial

REACCIONES SECUNDARIAS En algunos pacentes con neumotratla obstruciva cronica insufiioencia cardiaca no conshyulrerativa aguda los medicamenios que inhiben la moti- trolada hipersernsibilidad a los componentes ae la formuia nitestinal o retrasan el tiemoo del transito intestinal pue- PRECAUCIONES Dee usarse con cudaoc en nradic3rdia

ecpiotas el meqacolon oxco coma he 3aco m ariasis sinusal coque cardiogenico diaees meiitus cardioatas = cefalea aiimento de la presion intraocular taquicarcia

Cisuria y retencion aguda de arna emoarazo y nios menotes ae- 12 afts

V1A DE ADMINISTRACION Oral REACCIONES SECUNDARIAS lrritaion ocular conjuntvins vsiln borrosa eruacones cutaneds locaOizaas y gnoraizdics

DOSIFICACION Diarrea aguda Una cucwataa de soU ucaa nhi 5 mi por caca 10 g ae pto 2 c -- eS 3 Efecios sistemicos 9adrrmia nscenson oncoe brono

I mg- g pedod dl esoasmo irisuficncia ooa V 3foiaca ocacnalmenie -O IdM no di11legal d- contlU de t mii cefw 3 seaueaac de oca rausea rr3recs fatgo somnoien

- - 3 =5 S rS3C2 ca oaictaciones e icere sion

192 LAC LAYMETACY( CM ESTO-Can IIn l

Acido asctraico 50 mg Carconato de calco 15 mg

LABYMETACYN COMPUESTO de accbon anoflogistica ani piretica analgesica y relalante del musculo estnado se deoe a la asociaci6n de dos frmacos antirreumaticos la indometacina (no esteroidel y la dexametasona (hormonal) f el carisopro dol relaiance muscular la presenca en la f6rmula de carbo nato calcico avuda a prevenir la irntaci6n gasznca quf pooria producir la inaometacina

INDICACIONES LABYMETACYN COMPUESTO estA indicado en reumatismo agudo subagudo y esoecialmente en las forrnas articulares y musculares en goae en- sus Civersas formas en neuns polineuritis neuralgias y afecciones dodrosas ocasiona das par las inflamaciones do los tejiios

CONTRAINDICACIONES Niecs embarazo o lacrancia 01 cera pephica acdva historia recurrente do lesiones gastrointes-tina(es sensibilidad a la indomeracona estados convulsivospsicasis grnven (

PRECAUCIONES En preencia de trastrns p

epiiepsia parkinsonismo infecciones No conducir veniculos de motor durante el tratamiento Deberi aoministrarsa con alimen ros leche a un antidcido Si se presenta c-falea y 6sta persiste suspendase el tratamienco asi coma si ocurre sangrado intestR1 nal Usese con mayor precauci6n en los ancianos

REACCIONES SECUNDARIAS Cefalea v~rdgo confusi6n mental somnolencia y otras alteraciones psiquicas NAusea anorexia v6mito diarrea Ictericid y hepatitis Prurito urticaria Leucopenia puroura anemias aplsica y hemolitica tromboci topenia Tinnitus y sordera Cara de luna aumento de peso y apecico

DOSIS LABYMETACN COMPUESTO so administra por via oral aplicando la dosis a cada paciente de acuerdo con la to-lerancia y respuesta terapdudca

Oasis inicial Una cipsula 2 6 3 veces al dia deaendiendo de la intensidad del dolor an gota 6 cJosulas diarias recarshytidas en 3 tomas hasta la remisi6n de todos los sintomss

PRESENTACION Caja con 20 cipsulas

Antes de prescribi consulte la pag VIII eyenda 2 Reg Ncm 70015 S S

LABYS S A Av Popocatepe NOm 167 033 Mexico D F

PR0DUCTO NUEVO

L A C T C A R E T

Crema quida

Emollente humectante

FORMULA Cada 100 ml contienen

Acido lIActico 5 g Pirrolidona - carboxilato do sodio 25 g Excipiente cbp 100 ml

INDICACIONES Es una crema especialmente formulada para condiciones carac-erizadas pot resequedad de la piel

CONTRAINDICACIONES So desconocen hasta [a fecna

REACCIONES SECUNDARIAS Se desconocen haste la fecna

DOSIS Y MODO DE EMPLEO Desou6s de lavar la cail y manes rese suavemente dos veces al dia pot la maiana pot la nocne hasta qua so haya absorbido toalmen(e Ourad el tiemoo que sea necesario

PRESENTACION Frasco de plis-ico con 1-0 ml

Antes de prescbr r consulte Ia oag VIl leyenda 2 Reg Num S6gTamp S S

Hecho en Mxico 0or

LABORATORIOS ANE( S A

Av 1 Ncm 61 San Pedrn de Ins Pinos 000 xico 0 F

Balo licenca excusiva de -Tir- i Rr)R-1TORIFS- INC

L A C T O G L A N D N

Grageas

Galactgeno

FORMULA Cada GRAGEA contiene 01 g de ex- mama lequivaience a I g de mama frescal 01 g Ce eshyde olacenta (equivalence a 1 g de olacenta frezica - vicamina Bi 25 mg de tweagloiuiina

INOICACIONES Hipogalactia

CONTRAINDICACIONES Insuticiencia adrenal no shypacentes hioersensioles a algun componence de la t6rmrj

RACCIONES SECUNDARIAS Ocasionalmente na

vdmi(o y eruccion cuanea -

POSOLOGIA 1 a 2 grageas 3 veces al dfa Incar tratamiento t3n pronto so oOserve la insuficiencia dec

el resultado deseacoprolongarlo hasta que se obtenga

PRESENTACION Frasco con 50 grageas Antes de prescribir consulte a pig VIII eyenda

Reg Nm 13-2 S S

LABORATORIOS HORMONA S A do C V

Blvd M Avila Camacho NUm 470 San Andres Ae-z 53500 Naucalpan Edo da Mxico

MarCas registradas

L A C T O P E C T I N -611

usenin Astringents intesdnal opard rratamiUdo

ndiarrea -

FORMULA Hecha la mezcla cada 100 ml contienen a d 6

Lacolcitl os Actdfil o ofL1 za as Polvo de opto (al 10 de morfina) 0C00 -C 0 Pectina 10C a W iniculo cbp 100 -

ACCION LACTOPECTIN detiene la diarrea evita la de- dratacion calma el dolor y resiablece la flora intestinal

INDICACIONES Qiarreas agudas do cualquier etiloagiaLACTOPECTIN suele suspender la diarrea desoues de

primeras dosis par Ia general no requiere administrarsd 00 mas do 24 6 48 iuras Una vez controlada la diarrea 9 1 necesario seguir administrando el antimicrociano se Ecuacshyadrnistrese simultAneamente Lactovita a Lactovita S Pec- = -lacobacilos anabioticorresistentes- para conservar la 9

tesonal expuesta a la destrucci6n par Ia teraca andmicrcoisr6

CONTRAINDICACIONES Ob3truccion intestinal REACCIONES SECUNDARIAS A la dosis y en lasn-

ciones recomendadas las reacciones secundarias son muv ras sin embargo dosis muy elevadas poirian producirr efecos indeseables de los Olaiceos

POSOLOGIA Niiios monores do 1 aia z cucharadita (25 ml) n-

mente y luego Yz cucharadita desoues de coda evac jccentr Maximo 8 medias cucnaraditas en 12 haras

Nios mayores do 1 arjo I a 2 cucharaditas (5 a 0 descucs ae cab evacuacion Maxima 8 cucnaraits horas

Adultos I a 2 cucnaradas 115 a 30 ml) descues de evacJaccn

PRESENTACON Frasco con 0 ml El fresco n poivo oara reconstituir la susoension agregando ague

la serial marcada en la ePicueta

Antes dorescnbir consuirp t aq evendJ

Regs Nums 87PJYJ 1 74170 S S

ANDRE BIGAUX S A Av cenro tirra Tortes um 25 33r

0 T I L E N N F ANTI L

Solucdn

Antidiarreico

FORMULA Cada 100 ml contionon -era]da 20 mg centuo C 100 ml

Cjda cucharadita de 5 ml contiene 1 mg de clorhidrato

oeramida Un ml contiene 02 mg de clorhidrato de pT3-ida

I[ICACIONES Diarreas agudas

CONTRAINDICACIONES Constipacidn atoia intestinalintestinal Diarreas infecciosa a amebiana

cAUCIONES No debe administrarse par tiemo prolon ued deesDratr~agraeseis Unaoatinarunadepesin~s anos- No se administre a niios menores

-5s5 puede ocasionar una depresiin respiratorla grave

L rsucede el paciente dedera ser hospitalizaa inmedliata- mpleo de este medicamento urante el embarazo

lac-ancia queda bajo la responsabilidad del medico

REACCIONES SECUNDARIAS Puede precipitar el mega-- h toxico coma heptico Midriasis disrea cefalea ta-

3dia rash disuria retencion aguda de orina

DOSIS Una cucharodita de 5 ml par cada 10 kg de peso

3 veces 31 dia (01 mgkg de peso sin paso de 8 mg horas)

Sszender el tratamiento a) llegar al control de os sinto--z Ajusflarse a las dosis indicadas-_sAjusarsdsis andiadasls

pRESENTACION Frasco con 60 ml con cucharadita de 5 mlReg Ntam 0034M79 S S 003a 2d Reb csepg VIISPlanta

4n te s d e p rescr b ir c ons ulte la p ig V 11 ley e nd a 2

LABORATORIOS LIOMONT S A de C V

- e Ma Olloqui Ntim 28 03100 Mkico D F - arca registrada

J A N S S E N Tabletas

Gastrocinitico y antiom~tico

FORMULA Cada TABLETA cantiene Domperidona 10 excipiente cbp

DEFINICION La sustancia activa de MOTILIUM deg es una s-tesis original de los LABORATORIOS JANSSEN FARMA U-TICA (Domperidona R 33812 El mecanismo de acci6n de YTLIUM se basa en su ac-ividad bloqueadora doaminica - l+eica

Esudios farmacologicos en vivo e in vitro han mostrado deg Ze ai MOTILIUM aumenta la tonicicad del esinter esofgico

r-o con Io que evita el reflUlo gastroescf~gico b) MOTI-deg

restablece la funcion gasnca normal c) MOTILIUM no -cofca La secrecion g~strica

pur el reflujo gs-INDICACIONES al Molestias ocasionadaslais ()omo pirosis regurgitaciones y ardor en el abdtomnen

b) Molestias relacionadas con un mal tuncionamiento-T

fnco tales como flatulencia y sensacion de plenitud desoues as comidas nauseas 0 votreto

CONTRAINDICACIONES No conocidas hasia el momento conocen incomoatibilidades con otras sustancias eceoto

- i cue puecen innibir los efecos de MOTI-Otcclinergicoi -

emoleo de este medicamento durante el emrarazo oueCa desoonsaPicaddel meoico

REACCIONES SECUNDARIAS Se han eoonaao casos ats e nt o

-- C- celalea comcos y enioleclms facial

bullSIS Y ADMINISTRACION Adultus Ocs aoJetas 3 veces a1 30 ml11LIC antes ce as co-cas So es CE0sao sa

-L ser trmaca de nue-o a -es ce x

-SENTACON Cala on 30 tanoetas ce 11 -g

MOT 579

M 0 T I L I U M J A N S S E N

Suspens ifn gotas

Gastrocindticb y antiembtico

FORMULA Cada ml do las gotas contiene Domperidona 10 mg excipiente cbp

INDICACIONES a) Disfunci6n Zastrointestinal pediatrica como la dispepsia transitoria del lactante b) C6lico regurgitacian nusea y v6mito

CONTRAINDICACIONES No conocidas hasta el momento

No se conocen incompatibilidades con otras sustancias exshyceoto ls anticolinergicos que pueden inr jbir los efeclos de

deg MOTILIUM ADVERTENCIA En vista de cue las funciones metabdlicas

y de 12 barrera hemaienceflica no esi~n totolmente desshy

arrolladas durante los primeros meses de vida MOTILIUM al

igual que cualquier medicamento que se administre a lactantes

menores debera ser usado con cautela y bajo estrecha supershyvisi6n m dica

REACCIONES SECUNDARIAS So han reportado casos aislados de cefalea c6licos y enrojecimient facial

DOSIS Y ADMINISTRACION Una gota (= 03 mg) par

kg de peso corporal 3 veces al dia antes de las comidas

PRESENTACION Suspensi6n gotas Frasco con 20 ml (10 mg par ml)

Antes de prescribr consulte la pig VIII leyenda 2 Flgs N~ms 0042M79 y 0041M79 S S

FAR 79RANSENm M S d SJANSSEN FARMACEUTICA S AA do C V Carr Fed Mexico-Puebla km 995f c n s C a o N m 70 01090 DOficinas Canaa Nm 79 1 9 M~xicoM xi D FF

Marco registrada INVESTIGA DESCUBRE Y DESARROLLA

M O TI VA L Grageas SQUIBB

Tranquilizante y ostabilizador emocional

FORMULA Cada GRAGEA contiene Clorhidrato do nortripshy

tiliria equivalente a 10 mg de la base diclorhidrato de flufenashycina 05 mg excipiente cbp una gragea

INDICACIONES Eficaz tratamiento oe pacientes con ansieshydad ligera a moaerada con ension a agitac6n a ambas con

o sin depresibn coexistente CONTRAINDICACIONES La actividad anticolinergica de la

nonripilina constrtuve una contraindicacidn del uso do la corshybinaciun en pacientes can glaucoma y en pacientes_en quienes se puede esoerar problemas par retencin urinaria La combinashy

cibn fluienacina-nortriotriina no debe set administrada a pacienshytes balO tratamiento con inhibidores de ta MAO

PRECAUCIONES El empleo do este medicamento durante ei emoarazo queda baio la responsabilidad del meoico Se ha informao de discinesias tardias con la terapeutica fenotiacinica

largo plaza por Io cue se sugiere que la administracin dea estos compuestos como tranquilizantes no exceda-a los tes MeSCes

RECCIONES SECUNDARIAS Con la administracin de seauedad de boca constipacibnnoriptiina se ha informado

somnolencia y mareos DOSIS Una gragea tres vecs al dia

PRESENTACJN Frasco de 60 grageas Antes de prescribir nsulte la pag VIII leyenda 2

Reg Num 75601 S S E R SQUIBB amp SONS DE MEXICO S A do C V

Av Revolucion Num 1257 01C-a Mxico 0 F

En ef PECRC4tFIC P-74CTICO PARA EL 1ErIC0 encontrara una a2eis retamp encds mrods tomrnetas soore ijicres ce ret-rena en

18- zrvezg Ct1d0ofdtJoo

)1

192 LAC LAYMETACY( CM ESTO-Can IIn l

Acido asctraico 50 mg Carconato de calco 15 mg

LABYMETACYN COMPUESTO de accbon anoflogistica ani piretica analgesica y relalante del musculo estnado se deoe a la asociaci6n de dos frmacos antirreumaticos la indometacina (no esteroidel y la dexametasona (hormonal) f el carisopro dol relaiance muscular la presenca en la f6rmula de carbo nato calcico avuda a prevenir la irntaci6n gasznca quf pooria producir la inaometacina

INDICACIONES LABYMETACYN COMPUESTO estA indicado en reumatismo agudo subagudo y esoecialmente en las forrnas articulares y musculares en goae en- sus Civersas formas en neuns polineuritis neuralgias y afecciones dodrosas ocasiona das par las inflamaciones do los tejiios

CONTRAINDICACIONES Niecs embarazo o lacrancia 01 cera pephica acdva historia recurrente do lesiones gastrointes-tina(es sensibilidad a la indomeracona estados convulsivospsicasis grnven (

PRECAUCIONES En preencia de trastrns p

epiiepsia parkinsonismo infecciones No conducir veniculos de motor durante el tratamiento Deberi aoministrarsa con alimen ros leche a un antidcido Si se presenta c-falea y 6sta persiste suspendase el tratamienco asi coma si ocurre sangrado intestR1 nal Usese con mayor precauci6n en los ancianos

REACCIONES SECUNDARIAS Cefalea v~rdgo confusi6n mental somnolencia y otras alteraciones psiquicas NAusea anorexia v6mito diarrea Ictericid y hepatitis Prurito urticaria Leucopenia puroura anemias aplsica y hemolitica tromboci topenia Tinnitus y sordera Cara de luna aumento de peso y apecico

DOSIS LABYMETACN COMPUESTO so administra por via oral aplicando la dosis a cada paciente de acuerdo con la to-lerancia y respuesta terapdudca

Oasis inicial Una cipsula 2 6 3 veces al dia deaendiendo de la intensidad del dolor an gota 6 cJosulas diarias recarshytidas en 3 tomas hasta la remisi6n de todos los sintomss

PRESENTACION Caja con 20 cipsulas

Antes de prescribi consulte la pag VIII eyenda 2 Reg Ncm 70015 S S

LABYS S A Av Popocatepe NOm 167 033 Mexico D F

PR0DUCTO NUEVO

L A C T C A R E T

Crema quida

Emollente humectante

FORMULA Cada 100 ml contienen

Acido lIActico 5 g Pirrolidona - carboxilato do sodio 25 g Excipiente cbp 100 ml

INDICACIONES Es una crema especialmente formulada para condiciones carac-erizadas pot resequedad de la piel

CONTRAINDICACIONES So desconocen hasta [a fecna

REACCIONES SECUNDARIAS Se desconocen haste la fecna

DOSIS Y MODO DE EMPLEO Desou6s de lavar la cail y manes rese suavemente dos veces al dia pot la maiana pot la nocne hasta qua so haya absorbido toalmen(e Ourad el tiemoo que sea necesario

PRESENTACION Frasco de plis-ico con 1-0 ml

Antes de prescbr r consulte Ia oag VIl leyenda 2 Reg Num S6gTamp S S

Hecho en Mxico 0or

LABORATORIOS ANE( S A

Av 1 Ncm 61 San Pedrn de Ins Pinos 000 xico 0 F

Balo licenca excusiva de -Tir- i Rr)R-1TORIFS- INC

L A C T O G L A N D N

Grageas

Galactgeno

FORMULA Cada GRAGEA contiene 01 g de ex- mama lequivaience a I g de mama frescal 01 g Ce eshyde olacenta (equivalence a 1 g de olacenta frezica - vicamina Bi 25 mg de tweagloiuiina

INOICACIONES Hipogalactia

CONTRAINDICACIONES Insuticiencia adrenal no shypacentes hioersensioles a algun componence de la t6rmrj

RACCIONES SECUNDARIAS Ocasionalmente na

vdmi(o y eruccion cuanea -

POSOLOGIA 1 a 2 grageas 3 veces al dfa Incar tratamiento t3n pronto so oOserve la insuficiencia dec

el resultado deseacoprolongarlo hasta que se obtenga

PRESENTACION Frasco con 50 grageas Antes de prescribir consulte a pig VIII eyenda

Reg Nm 13-2 S S

LABORATORIOS HORMONA S A do C V

Blvd M Avila Camacho NUm 470 San Andres Ae-z 53500 Naucalpan Edo da Mxico

MarCas registradas

L A C T O P E C T I N -611

usenin Astringents intesdnal opard rratamiUdo

ndiarrea -

FORMULA Hecha la mezcla cada 100 ml contienen a d 6

Lacolcitl os Actdfil o ofL1 za as Polvo de opto (al 10 de morfina) 0C00 -C 0 Pectina 10C a W iniculo cbp 100 -

ACCION LACTOPECTIN detiene la diarrea evita la de- dratacion calma el dolor y resiablece la flora intestinal

INDICACIONES Qiarreas agudas do cualquier etiloagiaLACTOPECTIN suele suspender la diarrea desoues de

primeras dosis par Ia general no requiere administrarsd 00 mas do 24 6 48 iuras Una vez controlada la diarrea 9 1 necesario seguir administrando el antimicrociano se Ecuacshyadrnistrese simultAneamente Lactovita a Lactovita S Pec- = -lacobacilos anabioticorresistentes- para conservar la 9

tesonal expuesta a la destrucci6n par Ia teraca andmicrcoisr6

CONTRAINDICACIONES Ob3truccion intestinal REACCIONES SECUNDARIAS A la dosis y en lasn-

ciones recomendadas las reacciones secundarias son muv ras sin embargo dosis muy elevadas poirian producirr efecos indeseables de los Olaiceos

POSOLOGIA Niiios monores do 1 aia z cucharadita (25 ml) n-

mente y luego Yz cucharadita desoues de coda evac jccentr Maximo 8 medias cucnaraditas en 12 haras

Nios mayores do 1 arjo I a 2 cucharaditas (5 a 0 descucs ae cab evacuacion Maxima 8 cucnaraits horas

Adultos I a 2 cucnaradas 115 a 30 ml) descues de evacJaccn

PRESENTACON Frasco con 0 ml El fresco n poivo oara reconstituir la susoension agregando ague

la serial marcada en la ePicueta

Antes dorescnbir consuirp t aq evendJ

Regs Nums 87PJYJ 1 74170 S S

ANDRE BIGAUX S A Av cenro tirra Tortes um 25 33r

0 T I L E N N F ANTI L

Solucdn

Antidiarreico

FORMULA Cada 100 ml contionon -era]da 20 mg centuo C 100 ml

Cjda cucharadita de 5 ml contiene 1 mg de clorhidrato

oeramida Un ml contiene 02 mg de clorhidrato de pT3-ida

I[ICACIONES Diarreas agudas

CONTRAINDICACIONES Constipacidn atoia intestinalintestinal Diarreas infecciosa a amebiana

cAUCIONES No debe administrarse par tiemo prolon ued deesDratr~agraeseis Unaoatinarunadepesin~s anos- No se administre a niios menores

-5s5 puede ocasionar una depresiin respiratorla grave

L rsucede el paciente dedera ser hospitalizaa inmedliata- mpleo de este medicamento urante el embarazo

lac-ancia queda bajo la responsabilidad del medico

REACCIONES SECUNDARIAS Puede precipitar el mega-- h toxico coma heptico Midriasis disrea cefalea ta-

3dia rash disuria retencion aguda de orina

DOSIS Una cucharodita de 5 ml par cada 10 kg de peso

3 veces 31 dia (01 mgkg de peso sin paso de 8 mg horas)

Sszender el tratamiento a) llegar al control de os sinto--z Ajusflarse a las dosis indicadas-_sAjusarsdsis andiadasls

pRESENTACION Frasco con 60 ml con cucharadita de 5 mlReg Ntam 0034M79 S S 003a 2d Reb csepg VIISPlanta

4n te s d e p rescr b ir c ons ulte la p ig V 11 ley e nd a 2

LABORATORIOS LIOMONT S A de C V

- e Ma Olloqui Ntim 28 03100 Mkico D F - arca registrada

J A N S S E N Tabletas

Gastrocinitico y antiom~tico

FORMULA Cada TABLETA cantiene Domperidona 10 excipiente cbp

DEFINICION La sustancia activa de MOTILIUM deg es una s-tesis original de los LABORATORIOS JANSSEN FARMA U-TICA (Domperidona R 33812 El mecanismo de acci6n de YTLIUM se basa en su ac-ividad bloqueadora doaminica - l+eica

Esudios farmacologicos en vivo e in vitro han mostrado deg Ze ai MOTILIUM aumenta la tonicicad del esinter esofgico

r-o con Io que evita el reflUlo gastroescf~gico b) MOTI-deg

restablece la funcion gasnca normal c) MOTILIUM no -cofca La secrecion g~strica

pur el reflujo gs-INDICACIONES al Molestias ocasionadaslais ()omo pirosis regurgitaciones y ardor en el abdtomnen

b) Molestias relacionadas con un mal tuncionamiento-T

fnco tales como flatulencia y sensacion de plenitud desoues as comidas nauseas 0 votreto

CONTRAINDICACIONES No conocidas hasia el momento conocen incomoatibilidades con otras sustancias eceoto

- i cue puecen innibir los efecos de MOTI-Otcclinergicoi -

emoleo de este medicamento durante el emrarazo oueCa desoonsaPicaddel meoico

REACCIONES SECUNDARIAS Se han eoonaao casos ats e nt o

-- C- celalea comcos y enioleclms facial

bullSIS Y ADMINISTRACION Adultus Ocs aoJetas 3 veces a1 30 ml11LIC antes ce as co-cas So es CE0sao sa

-L ser trmaca de nue-o a -es ce x

-SENTACON Cala on 30 tanoetas ce 11 -g

MOT 579

M 0 T I L I U M J A N S S E N

Suspens ifn gotas

Gastrocindticb y antiembtico

FORMULA Cada ml do las gotas contiene Domperidona 10 mg excipiente cbp

INDICACIONES a) Disfunci6n Zastrointestinal pediatrica como la dispepsia transitoria del lactante b) C6lico regurgitacian nusea y v6mito

CONTRAINDICACIONES No conocidas hasta el momento

No se conocen incompatibilidades con otras sustancias exshyceoto ls anticolinergicos que pueden inr jbir los efeclos de

deg MOTILIUM ADVERTENCIA En vista de cue las funciones metabdlicas

y de 12 barrera hemaienceflica no esi~n totolmente desshy

arrolladas durante los primeros meses de vida MOTILIUM al

igual que cualquier medicamento que se administre a lactantes

menores debera ser usado con cautela y bajo estrecha supershyvisi6n m dica

REACCIONES SECUNDARIAS So han reportado casos aislados de cefalea c6licos y enrojecimient facial

DOSIS Y ADMINISTRACION Una gota (= 03 mg) par

kg de peso corporal 3 veces al dia antes de las comidas

PRESENTACION Suspensi6n gotas Frasco con 20 ml (10 mg par ml)

Antes de prescribr consulte la pig VIII leyenda 2 Flgs N~ms 0042M79 y 0041M79 S S

FAR 79RANSENm M S d SJANSSEN FARMACEUTICA S AA do C V Carr Fed Mexico-Puebla km 995f c n s C a o N m 70 01090 DOficinas Canaa Nm 79 1 9 M~xicoM xi D FF

Marco registrada INVESTIGA DESCUBRE Y DESARROLLA

M O TI VA L Grageas SQUIBB

Tranquilizante y ostabilizador emocional

FORMULA Cada GRAGEA contiene Clorhidrato do nortripshy

tiliria equivalente a 10 mg de la base diclorhidrato de flufenashycina 05 mg excipiente cbp una gragea

INDICACIONES Eficaz tratamiento oe pacientes con ansieshydad ligera a moaerada con ension a agitac6n a ambas con

o sin depresibn coexistente CONTRAINDICACIONES La actividad anticolinergica de la

nonripilina constrtuve una contraindicacidn del uso do la corshybinaciun en pacientes can glaucoma y en pacientes_en quienes se puede esoerar problemas par retencin urinaria La combinashy

cibn fluienacina-nortriotriina no debe set administrada a pacienshytes balO tratamiento con inhibidores de ta MAO

PRECAUCIONES El empleo do este medicamento durante ei emoarazo queda baio la responsabilidad del meoico Se ha informao de discinesias tardias con la terapeutica fenotiacinica

largo plaza por Io cue se sugiere que la administracin dea estos compuestos como tranquilizantes no exceda-a los tes MeSCes

RECCIONES SECUNDARIAS Con la administracin de seauedad de boca constipacibnnoriptiina se ha informado

somnolencia y mareos DOSIS Una gragea tres vecs al dia

PRESENTACJN Frasco de 60 grageas Antes de prescribir nsulte la pag VIII leyenda 2

Reg Num 75601 S S E R SQUIBB amp SONS DE MEXICO S A do C V

Av Revolucion Num 1257 01C-a Mxico 0 F

En ef PECRC4tFIC P-74CTICO PARA EL 1ErIC0 encontrara una a2eis retamp encds mrods tomrnetas soore ijicres ce ret-rena en

18- zrvezg Ct1d0ofdtJoo

)1

0 T I L E N N F ANTI L

Solucdn

Antidiarreico

FORMULA Cada 100 ml contionon -era]da 20 mg centuo C 100 ml

Cjda cucharadita de 5 ml contiene 1 mg de clorhidrato

oeramida Un ml contiene 02 mg de clorhidrato de pT3-ida

I[ICACIONES Diarreas agudas

CONTRAINDICACIONES Constipacidn atoia intestinalintestinal Diarreas infecciosa a amebiana

cAUCIONES No debe administrarse par tiemo prolon ued deesDratr~agraeseis Unaoatinarunadepesin~s anos- No se administre a niios menores

-5s5 puede ocasionar una depresiin respiratorla grave

L rsucede el paciente dedera ser hospitalizaa inmedliata- mpleo de este medicamento urante el embarazo

lac-ancia queda bajo la responsabilidad del medico

REACCIONES SECUNDARIAS Puede precipitar el mega-- h toxico coma heptico Midriasis disrea cefalea ta-

3dia rash disuria retencion aguda de orina

DOSIS Una cucharodita de 5 ml par cada 10 kg de peso

3 veces 31 dia (01 mgkg de peso sin paso de 8 mg horas)

Sszender el tratamiento a) llegar al control de os sinto--z Ajusflarse a las dosis indicadas-_sAjusarsdsis andiadasls

pRESENTACION Frasco con 60 ml con cucharadita de 5 mlReg Ntam 0034M79 S S 003a 2d Reb csepg VIISPlanta

4n te s d e p rescr b ir c ons ulte la p ig V 11 ley e nd a 2

LABORATORIOS LIOMONT S A de C V

- e Ma Olloqui Ntim 28 03100 Mkico D F - arca registrada

J A N S S E N Tabletas

Gastrocinitico y antiom~tico

FORMULA Cada TABLETA cantiene Domperidona 10 excipiente cbp

DEFINICION La sustancia activa de MOTILIUM deg es una s-tesis original de los LABORATORIOS JANSSEN FARMA U-TICA (Domperidona R 33812 El mecanismo de acci6n de YTLIUM se basa en su ac-ividad bloqueadora doaminica - l+eica

Esudios farmacologicos en vivo e in vitro han mostrado deg Ze ai MOTILIUM aumenta la tonicicad del esinter esofgico

r-o con Io que evita el reflUlo gastroescf~gico b) MOTI-deg

restablece la funcion gasnca normal c) MOTILIUM no -cofca La secrecion g~strica

pur el reflujo gs-INDICACIONES al Molestias ocasionadaslais ()omo pirosis regurgitaciones y ardor en el abdtomnen

b) Molestias relacionadas con un mal tuncionamiento-T

fnco tales como flatulencia y sensacion de plenitud desoues as comidas nauseas 0 votreto

CONTRAINDICACIONES No conocidas hasia el momento conocen incomoatibilidades con otras sustancias eceoto

- i cue puecen innibir los efecos de MOTI-Otcclinergicoi -

emoleo de este medicamento durante el emrarazo oueCa desoonsaPicaddel meoico

REACCIONES SECUNDARIAS Se han eoonaao casos ats e nt o

-- C- celalea comcos y enioleclms facial

bullSIS Y ADMINISTRACION Adultus Ocs aoJetas 3 veces a1 30 ml11LIC antes ce as co-cas So es CE0sao sa

-L ser trmaca de nue-o a -es ce x

-SENTACON Cala on 30 tanoetas ce 11 -g

MOT 579

M 0 T I L I U M J A N S S E N

Suspens ifn gotas

Gastrocindticb y antiembtico

FORMULA Cada ml do las gotas contiene Domperidona 10 mg excipiente cbp

INDICACIONES a) Disfunci6n Zastrointestinal pediatrica como la dispepsia transitoria del lactante b) C6lico regurgitacian nusea y v6mito

CONTRAINDICACIONES No conocidas hasta el momento

No se conocen incompatibilidades con otras sustancias exshyceoto ls anticolinergicos que pueden inr jbir los efeclos de

deg MOTILIUM ADVERTENCIA En vista de cue las funciones metabdlicas

y de 12 barrera hemaienceflica no esi~n totolmente desshy

arrolladas durante los primeros meses de vida MOTILIUM al

igual que cualquier medicamento que se administre a lactantes

menores debera ser usado con cautela y bajo estrecha supershyvisi6n m dica

REACCIONES SECUNDARIAS So han reportado casos aislados de cefalea c6licos y enrojecimient facial

DOSIS Y ADMINISTRACION Una gota (= 03 mg) par

kg de peso corporal 3 veces al dia antes de las comidas

PRESENTACION Suspensi6n gotas Frasco con 20 ml (10 mg par ml)

Antes de prescribr consulte la pig VIII leyenda 2 Flgs N~ms 0042M79 y 0041M79 S S

FAR 79RANSENm M S d SJANSSEN FARMACEUTICA S AA do C V Carr Fed Mexico-Puebla km 995f c n s C a o N m 70 01090 DOficinas Canaa Nm 79 1 9 M~xicoM xi D FF

Marco registrada INVESTIGA DESCUBRE Y DESARROLLA

M O TI VA L Grageas SQUIBB

Tranquilizante y ostabilizador emocional

FORMULA Cada GRAGEA contiene Clorhidrato do nortripshy

tiliria equivalente a 10 mg de la base diclorhidrato de flufenashycina 05 mg excipiente cbp una gragea

INDICACIONES Eficaz tratamiento oe pacientes con ansieshydad ligera a moaerada con ension a agitac6n a ambas con

o sin depresibn coexistente CONTRAINDICACIONES La actividad anticolinergica de la

nonripilina constrtuve una contraindicacidn del uso do la corshybinaciun en pacientes can glaucoma y en pacientes_en quienes se puede esoerar problemas par retencin urinaria La combinashy

cibn fluienacina-nortriotriina no debe set administrada a pacienshytes balO tratamiento con inhibidores de ta MAO

PRECAUCIONES El empleo do este medicamento durante ei emoarazo queda baio la responsabilidad del meoico Se ha informao de discinesias tardias con la terapeutica fenotiacinica

largo plaza por Io cue se sugiere que la administracin dea estos compuestos como tranquilizantes no exceda-a los tes MeSCes

RECCIONES SECUNDARIAS Con la administracin de seauedad de boca constipacibnnoriptiina se ha informado

somnolencia y mareos DOSIS Una gragea tres vecs al dia

PRESENTACJN Frasco de 60 grageas Antes de prescribir nsulte la pag VIII leyenda 2

Reg Num 75601 S S E R SQUIBB amp SONS DE MEXICO S A do C V

Av Revolucion Num 1257 01C-a Mxico 0 F

En ef PECRC4tFIC P-74CTICO PARA EL 1ErIC0 encontrara una a2eis retamp encds mrods tomrnetas soore ijicres ce ret-rena en

18- zrvezg Ct1d0ofdtJoo

)1

714 PRO PRCI--C on in-i(X-C

CONTRAINOICACIONES La 3admnistracn de este com- ACCION Oivcocrdroaujnoiena es ameocda e ouesto est contraincicado en casos de anuria y aoiguria 1 el tratamento de la lorr-a nescal de a nieccon dano renal grave ecbromuro de iomacrooina es antiesoasmGcico

REACCIONES SECUNDARIAS Se ha comunicado la oser F3ahlbulfatiazol es un aqente anciaacerlano ncestinal vacdn de neuntis oerifenca en un reducdo numero de pacen- INOICACIONES Oiarreas bacterianas inctuyenco Sn zes En la mavona de ellos la insuficiencia renal era un factor asocaao a dmeoiasis predisonente CONTRAINOICACIONES A uria oligura alerga al

OOSIS Infecciones urinarias y prostaciti aguda en el aduito oersonas hioersensibles a las suitas nsuficienc3 heoarj oramecio se recomienda una dosis Ce 10 mg 4 veces al dia renal disolasta medular Ce 10 a 14 dias tomaca preferentemente desoues de las comi- REACCIONES SECUNOARIAS En agunos casos irr clas crincioaies v con alg~n almenco 0 lecne al 3costars- Ei gasmca tanuicardia te-oores i1uer13d Ce boca v -shypacientes con peso menor que ei pronedio la dosis aecoe calcu- borrosa Iarse con base de 5 a 7 mg par kilo de peso corporal par dia DOSIS De 600 mg a 2 g al dia reartidos en 3 tor4 fraccionada en 4 comas guales y sin exceder 400 mg oar dia [a droga no deae adminstrarse a recien nacidos PRESENTACION Cjja con 20 tablecas

El cratamiento Ce suoresion a mantenimiento par largos pe- Antes de prescribir consulte la pig VI11 leyenaa 2 racos puede ser necesarfo si la teracia esta inicada par Reg N~m 84142 S S mas de 14-cias dece considerarse la reduccicn de la Oosis a PROVIT S A un 25 o 50 de Ia dlosis teraoeucica tocal Niio Arzillera N~m 5M CU Indecendencia5C070 Toluca -

PRESENTACION Caja con 12 cpsulas Anres de rescfir consulte a pg VII eyenda I P R 0 P A N T E L

R eg Num 8444 S S ea- (ag

PROVIT S A Nifa Ar illero N~m 500 CU Indeendencia-50070 Toluca M6x Parasimpaticoliico

Antisecretor ghstrica y actiespasmddico

PROOUCTO NUEVO FORMULA Cada GRAGEA contiene Bromuro de propantelina 15 -1

INDICACIONES En 6lcera p1otica y gastrriisPROPAJT--

TaOletas es un antcolinrgico doolemente eficaz ya que se caraca i

par disminuir tanto la secrecin g~strica coma el esasrs-c Andiinflamatorio analg~sico y antirreumtico con menoes cectos secundarios

FORMULA Cada TASLETA condoene PROPANTEL tambien acria contra los esoasmos del intestr= delgado y grueso par Ia que su usa esta indicado en cC

Naoroxin 250 mq y enteritis Excipiente cbp I tableta PROPANTEL es eficaz en todos los casos de cdistorias rt--

INDICACIONES Es un antirreumatica no hormonal Antiin- rovegetativas con predominio del parasimpacico flamatoria indcado en enfermedades reumticas tales coma CONTRAINDICACIONES Glaucoma e hipertrofia prostazj artritis reumatoide y osteoartritis en reumatismo extraarticular obsrUccibn pil6rica enfermedades coronanas taquicardia coma bursitis tendinitis y tenosinovitis

REACCIONES SECUNDARIAS Sequecad de boca micrQCONTRAINDICACIONES No deberd administrarse a muje- s visiun borrosa oliguria taquicardia n~useas constipacCt

res embarazadas a en periodo de lactancia o a pacientes hipotensi6n ortosdtca ccn insuficiencia hepitica a renal En los menores de edad no so ha precisado an Ia dossiicaci6n ni la tolerancia POSOLOGIA 1 a 2 grageas 4 veces at die

PRESENTACION Caja con 36 grageasREACCIONES SECUNDARIAS Los pacientes con antece- Antes de prescnbir consulte la pig VII leyenda 2

dences de padecimieno gastrointestinal debern ser siempre oojeto de cuidadosa observacs6n Ya qua pueden presentar Reg NOm 42190 S S molescras abdominale pirosis a r useas asi como algunos ca- LABORATORIOS GASTROENTEROLOGICOS S A sos de sangrado gastrointestinal en pacientes trarados con el Vena NCim 56 04100 Mexico 0 producto En casos raro -pueden presentarsa cefalea mareo a trambociooenia

PRO0SID0 ERA L DOSIS La dosis inicial diaria es de 500 mg distribuidos en

2 comas en Ia marlana y en fa noche cuando no so obtenga CjpSulas una resouesa r~pida al tratamien(o inicial puede aumentarse a 750 mg diarios 13 tabletas siecrpro rerardas en 2 comas ara las deficiancias do las vitaminas do la fIrmu1

=

PRESENTACION Caja con 30 tabletas FORMULA Cada CAPSULA con vitaminas condone Antes de prescribir consulte la pig VIII eyenda 2 Clanocobalamina (vitamina S12 10

P3lmitato de vitamina A 10 00 UReg Num 030M84 S S Calciteral (vitamina 00 IC0 _ I

PROOUCTOS MAVI S A Clorhidraro de tamna 10 - Osa 1encr ~0n 197 04220 MAxico 0 F (equivalence a 3 30 U I de vitamina B)

vina Hiboni vnar -1

Niacina ida t -4 gt Acio asc~rbir co1

PRMEAs (ecuivalente a 1 0 U I de vitamina C)

Cada CAPSULA con minerales contionde

Amebicida antiseotico y anciespasmodico intestinal Gcerofosfaco de caico C nosito hexafostato de aico rnaqrpcso

FORMULA Coda 7ABL-TA contione Fosfato dicalcico

5-7 divodO 3 hcro-uunoirna 0 21 g Yfajro de ociasio - - 4] -icaz i 3oor-P as jitarlir -

1 ja rarina O-e s 3J

-brqmurr e -nrnatry 0 C5 es~neJes

SCO STR STCPE4--C3 tia

INOICACIONES TERAPEUTICAS Colitis producidas par bacterias ameoas y manilias Diarreas do tipo inescecifico con desarrollo secuidario de bacerias y manilias

CONTRAINDICACIONES Aronia intestinal glaucoma hiper trofia prostc-ca

REACCIONES SECUNDARIAS En algunas ocasiones pue-den presencarse nauseas v~micos y erupciones cutaneas hematuria crstaluria

POSOIOGIA Adultas Una cucharada 4 veces al dia

Nitos do 4 a 8 alo Vz cucharadita 3 veces al dia dn 8 a 12 auos Una cucharadita 4 veces al dia

PRESENTACION Frasco con 100 ml

Antes de prescribir consulte la pig VIII levenda I

Reg Nom 66092 S S

BERMAN LABORATORIOS S A d o C V

tr ________________________ 60LEDERLE 0____________ 0_F_

Sus~venson LL Antibi6tico y antidiarreica

Antidiarreico adsorbente y protector do la mucosa intestinal

FORMUL- Cada 100 ml contienen Sulfato de dihidro-estrrncina e-cuivalente a 100 g de dihidroestreptomicna base Adsoroin (silicato hidratado de aluminio y magnesia) 1000 g peccnO0c0 g gel de hidroxido de aluminio 3600 ml (equivalente a 0882 g de oxido de aluminio) veniculo cbo 10000 ml

DESCRIPCION STREPTOMAGMA permite [a remisi6n de las diarreas Posee acci6n antibacteriana in situ adsorbe las bacterias pat6genas y sus productos txicos e rritanres proshy

tege c3lma y reduce la inilamacion de la mucosa intestinal y estimula la formac1in de heces normales

INDICACIONES Traramiento esoecifico de las diarreas causadas par micrcorganismos sensibles a la estretomicina

CONTRAINOICACIONES Insuficiencia renal Sensibilidad a la estreptomicina

REACCIONES SECUDARIAS Su adminisiracion puede producir estreimoiento su usa prolongado pueda producir pro-liferacian do flora resisterne a Ia formula

DOSIFICACION Y ADMINISTRACIONAdultos I cucharada (10 ml) 4 vece3 at 6~a

Niios La dosis usual as de una cucharadita (5 mil) 4 ve-ces al dia

PRESENTACION Frasco con 90 ml do suspensi6n orzl

la pig VIII leyenda 2Antes de orescribir consulte

Reg Num 39364 S S WYETH-VALES SA

Av Poniente 134 N6m 740 02300 Mexico 0 F

STREPTOMAGMA es una marca registrada

T A B S 6 0 0S RE S S

Grageas

Firmula vitaminica contra las deficiencias vitaminicas par stress

FORMULA Cada GRAGEA contieneMraeisrd

S ccnio mononlr3tO o oaminal 15 mg

Vitamina 8 I notlavina) 15 mg

Vitamna 8j Icorn~radco do oindoxina) 5 mg Concenrtrao rp mojiamiln 5 mcg Vitafnsn C icc~m jcri iscornicoi 0 mg

acnarnid3 - 100 mg

Vitartrna

d dIM ocotpriOcsue0rie mvaamin a E ccm n u -ato

J pintorena 1j a gf

~conce~ Ig2iej

DESCRIPCION Formula a base c~e jiramias an car- suricientes para cubrtr as necesid3des aumentacas rr sriess

INDICACIONES Para corregir las deficiincias del de cualouiera de los componentes de la formula

CONTRAINOICACIONES Hioerfsensibildad a cualquu sus componentes

REACCIONES SECUNOARIAS Nausea diarrea o hic-

1

sibilidad a algunas de los componences de la formula P gitacin con sabcr a alguna de las vitaminas de la fg--

DOSIS PROMEDIO I gragea al dfa a mis a juico meaiaa

PRESENTACION Frasco con 30 grageas

Anes de presrribir consulte la pig V11Ilevenda Reg Nim 76666 S S

CYANAMID DE MEXICO S A de C V

DIVISION DE PRODUCTOS MEDICOS Calz de Tialpan Num 3092 04910 Mexico 0 PMarca registrada

S TU G ER O N FO R TE

J a n s s e n Tableras

DOeficiencias do Ia circulaci6n cerebral y antivertiginoso FORMULA Cada TA3LETA oontiene 75 mg de cinancaa Fct

eACCION STUGERON FORTE mejora la irrigaci6n cer ar-m

donde mas se necesita proporcionando roido alivio de os sintomas y una objeriva mejora cuando se uuliza coma tjshypia de mantenimiento en deficiencias circulatorias

INDICACIONES STUGERON FORTE esta indicado en trataInto do FOs es dIa d nieshycirculataria cerebral on los pacientes do Ia 3a eca

Perdida de la memaria Vertigo

Cefalea Alteracianes de la conducta Insomnia

Falta do concentraci6n Indicado tambin en sindrome vertiginoso de cualquier -i

logia y patologia vascular gerfitrica CONTRAINDICACIONES EstA concraindicado en Cs505

hemorragia cerebral reciente

REACCIONES SECUNDARIAS La tolerancia es exrt-tr Los ecos colaterales tales coma somnolencia y trastf gastraintestinales son infrecuentes y pasajeros se les 0 f~cilmente adaptando gradualmente la posologia optima Stshy

pre quo sea necesario puede efectuarse una teraoia zoaa -C_shycon otas medicacianes

DOSIS Una tableta cada 12 hoas Para obrener ur- jar resouesta se recomiendan tratamientos prolongadCS

En el sindromne vertiginoso se aconsela un tracarren

inferior a 90 dias p 2ra evitar recidivas =PRESENTACIONES STUGERON FORTE se presert -z

jas con 30 y 60 tabletas conieniendo cada rableta 75

cinancina

Antes de presarbir consute a pjq VI1I Ieend- Reg Nim 84564 S S

JANSSEN FARMACEUTICA S A de C V Plan(a Carr Fed fio-Puebla km 9 5

Oficinas Canoe Num 79 01090 MeAia 0

INVESTIGA DESCUERE f OESARROLLA

amp EaCN4 Oc P70canres i 7 GUhA OePOOVEEDOFtj Rc pound AL -

lenfIccn 1ricrle U8 ISDOSICICn yr7 j700On V ) j

u Coniflujato n tj -Cj 1

SCO STR STCPE4--C3 tia

INOICACIONES TERAPEUTICAS Colitis producidas par bacterias ameoas y manilias Diarreas do tipo inescecifico con desarrollo secuidario de bacerias y manilias

CONTRAINDICACIONES Aronia intestinal glaucoma hiper trofia prostc-ca

REACCIONES SECUNDARIAS En algunas ocasiones pue-den presencarse nauseas v~micos y erupciones cutaneas hematuria crstaluria

POSOIOGIA Adultas Una cucharada 4 veces al dia

Nitos do 4 a 8 alo Vz cucharadita 3 veces al dia dn 8 a 12 auos Una cucharadita 4 veces al dia

PRESENTACION Frasco con 100 ml

Antes de prescribir consulte la pig VIII levenda I

Reg Nom 66092 S S

BERMAN LABORATORIOS S A d o C V

tr ________________________ 60LEDERLE 0____________ 0_F_

Sus~venson LL Antibi6tico y antidiarreica

Antidiarreico adsorbente y protector do la mucosa intestinal

FORMUL- Cada 100 ml contienen Sulfato de dihidro-estrrncina e-cuivalente a 100 g de dihidroestreptomicna base Adsoroin (silicato hidratado de aluminio y magnesia) 1000 g peccnO0c0 g gel de hidroxido de aluminio 3600 ml (equivalente a 0882 g de oxido de aluminio) veniculo cbo 10000 ml

DESCRIPCION STREPTOMAGMA permite [a remisi6n de las diarreas Posee acci6n antibacteriana in situ adsorbe las bacterias pat6genas y sus productos txicos e rritanres proshy

tege c3lma y reduce la inilamacion de la mucosa intestinal y estimula la formac1in de heces normales

INDICACIONES Traramiento esoecifico de las diarreas causadas par micrcorganismos sensibles a la estretomicina

CONTRAINOICACIONES Insuficiencia renal Sensibilidad a la estreptomicina

REACCIONES SECUDARIAS Su adminisiracion puede producir estreimoiento su usa prolongado pueda producir pro-liferacian do flora resisterne a Ia formula

DOSIFICACION Y ADMINISTRACIONAdultos I cucharada (10 ml) 4 vece3 at 6~a

Niios La dosis usual as de una cucharadita (5 mil) 4 ve-ces al dia

PRESENTACION Frasco con 90 ml do suspensi6n orzl

la pig VIII leyenda 2Antes de orescribir consulte

Reg Num 39364 S S WYETH-VALES SA

Av Poniente 134 N6m 740 02300 Mexico 0 F

STREPTOMAGMA es una marca registrada

T A B S 6 0 0S RE S S

Grageas

Firmula vitaminica contra las deficiencias vitaminicas par stress

FORMULA Cada GRAGEA contieneMraeisrd

S ccnio mononlr3tO o oaminal 15 mg

Vitamina 8 I notlavina) 15 mg

Vitamna 8j Icorn~radco do oindoxina) 5 mg Concenrtrao rp mojiamiln 5 mcg Vitafnsn C icc~m jcri iscornicoi 0 mg

acnarnid3 - 100 mg

Vitartrna

d dIM ocotpriOcsue0rie mvaamin a E ccm n u -ato

J pintorena 1j a gf

~conce~ Ig2iej

DESCRIPCION Formula a base c~e jiramias an car- suricientes para cubrtr as necesid3des aumentacas rr sriess

INDICACIONES Para corregir las deficiincias del de cualouiera de los componentes de la formula

CONTRAINOICACIONES Hioerfsensibildad a cualquu sus componentes

REACCIONES SECUNOARIAS Nausea diarrea o hic-

1

sibilidad a algunas de los componences de la formula P gitacin con sabcr a alguna de las vitaminas de la fg--

DOSIS PROMEDIO I gragea al dfa a mis a juico meaiaa

PRESENTACION Frasco con 30 grageas

Anes de presrribir consulte la pig V11Ilevenda Reg Nim 76666 S S

CYANAMID DE MEXICO S A de C V

DIVISION DE PRODUCTOS MEDICOS Calz de Tialpan Num 3092 04910 Mexico 0 PMarca registrada

S TU G ER O N FO R TE

J a n s s e n Tableras

DOeficiencias do Ia circulaci6n cerebral y antivertiginoso FORMULA Cada TA3LETA oontiene 75 mg de cinancaa Fct

eACCION STUGERON FORTE mejora la irrigaci6n cer ar-m

donde mas se necesita proporcionando roido alivio de os sintomas y una objeriva mejora cuando se uuliza coma tjshypia de mantenimiento en deficiencias circulatorias

INDICACIONES STUGERON FORTE esta indicado en trataInto do FOs es dIa d nieshycirculataria cerebral on los pacientes do Ia 3a eca

Perdida de la memaria Vertigo

Cefalea Alteracianes de la conducta Insomnia

Falta do concentraci6n Indicado tambin en sindrome vertiginoso de cualquier -i

logia y patologia vascular gerfitrica CONTRAINDICACIONES EstA concraindicado en Cs505

hemorragia cerebral reciente

REACCIONES SECUNDARIAS La tolerancia es exrt-tr Los ecos colaterales tales coma somnolencia y trastf gastraintestinales son infrecuentes y pasajeros se les 0 f~cilmente adaptando gradualmente la posologia optima Stshy

pre quo sea necesario puede efectuarse una teraoia zoaa -C_shycon otas medicacianes

DOSIS Una tableta cada 12 hoas Para obrener ur- jar resouesta se recomiendan tratamientos prolongadCS

En el sindromne vertiginoso se aconsela un tracarren

inferior a 90 dias p 2ra evitar recidivas =PRESENTACIONES STUGERON FORTE se presert -z

jas con 30 y 60 tabletas conieniendo cada rableta 75

cinancina

Antes de presarbir consute a pjq VI1I Ieend- Reg Nim 84564 S S

JANSSEN FARMACEUTICA S A de C V Plan(a Carr Fed fio-Puebla km 9 5

Oficinas Canoe Num 79 01090 MeAia 0

INVESTIGA DESCUERE f OESARROLLA

amp EaCN4 Oc P70canres i 7 GUhA OePOOVEEDOFtj Rc pound AL -

lenfIccn 1ricrle U8 ISDOSICICn yr7 j700On V ) j

u Coniflujato n tj -Cj 1

932 YOD

sat y estmulante del catablisno en oroblsmas ce ~ooscad sceCe sustec s S e s Snlipvtas Prcreus uxiiiar en reumatismo crorfco y artrinls reumaric3 Anioo corcis cOlc ta--o jp j clOso

CONTRAINOICACIONES Snsibciu a aigno d CONTRAINOICACIONES No aeoen inaeritse simultane3 pon-nres de ia rmuJ --rsonas micersen$sriq al a(f

mente medacrrnientos antiacidos Idiosincrasia al yodo Oasis rtrolilsmoaitas en padeclmlencos tiruideoS REACCIONES SECUNOARIAS Puece crcducr ocasnr-

REACCIONES SECUNDARIAS Ocasonaimente lige3 rono aoLrar-ia nsormnio nauseas vomcu y rucon cufarai rre3 al niciar el tratamiento Nauseas cefaltla Y fieore moce rada Si se administran dosis altas sin irea progre ian DOSIS

Adultos Una cuclarada 4 vec-s al dia MODO DE EMPLEO Administrese durance las comidas ana a veces 03Niuos cucharad a al

Ni os Media a una cucharadira 4 a 6 veces al -ij

DOSIFICACION Oasis progresivas desde 1 d 2 hast3 30 raoieras (a gramos) diarios segun el caso y la edad del en- PRESENTACION Frasco can 60 mi fermo Antes de rescnoir consulte a pig VIII leyend r

PRESENTACIONES Frascas con 50 100 y 200 tabletas Reg Nrr 83274 -e S de I g rascos con 200 g de polvo (caaa gramo equivaie a ESTABLECIMIENTOS JOFRAIN S A una tacOile Calz de Tlaloan Ncm 2621 04610 M xco O

Antes de rescnbir consulte a ojg VIII eyenda I Regs Nums 10249 y 41208 S S Y O S U L LABORATORIOS MANUELL S A

Av del Trabalo Num 237 15270 Mexico 0 F Suspenscn y tableras

Antisiptico intes-tinal

0D OLA CT VA FORMULA Cada 100 ml Cada TABLE

Suspensid contienen contiene YodoclorohidroxioLinaina 2C00 g 0250 q

Medicacin yodada Ka1j 20000 g --Pe a 1000 g --

FORMULA Cada 100 ml contienen Metibromura de Yoaocaseina Manuell 500 g homatropina 0010 g Lactosa 00 g Vehiculo cbp 100 ml Sorbito 900 g CarbOn activo 0050 qVehiculo cbo 10000 ml Clorhidrato de papaverina -- 0100 Agitese bien antes de usarse Excipiente cb --

INDICACIONES Auxiliar en ciertas formas de tuberculosis INDICACIONES Coaoyuvance en disenteria bacdlar Ctv ganglionar Auxiliar en enfisema pulmonar asma I bronaultis nra ameoiana algunas formas de colitis ulcerosa enre- cronica Escerolitico Modificacor del me-inoismo de las grasas diarreas aisenteniformes gastroenteritis colius agudas y estimulante del caracolsmo en proclerrias de obesidad Auxi liar en reumatismo cranico y artnatis reumatic3 Antibocoso CONTRAINDICACIONES En personas aldrgicas ai

Taquicarcia hipertrofia prostatica arrtmias caraiacas CONTRAINDICACIONES No deben ingerirse simultaneashy

mente medicamentos antiacidos Iciosincrasia al yodo Oasis REACCIONES SECUNDARIAS Su adminisracidn acshyaltas en paCecmiencos tiroadeos de ctialquier sustancia yoaaa altera fa3 pruecas de lshy

tircidea puede producir midriasis sequedad de boca REACCIONES SECUNOARIAS Ocasionalmente ligera rino- bia ocasionalmente constipacon y retenc16n de orina

rrea al iniciar el ratamiento Nauseas cefalea y liebre made veces puede causar prurito anal a dermato-is en Pel rada en muy raras ocasiones sensibles al yodo

MOOO DL EMPLEO Administrese durante las comidas DOSIS Adultos Oe 1 a 2 cucharadas a tableras 4 veceS00S1S Desde hasra 2 cucharaditas de 5 ml de una a

tres veces al da seg n edad 20 gotas equivaln a 1 ml Niiios I cucharadita 4 veces al dia

PRESENTACIONES Frasco gotero de 25 ml y frasco de PRESENTACIONES Frasco con 60 ml y 120 ml con cucharitla para dosificar Cala con 20 tabletas

Antes de prescribir consulte la pig VIII eyend I Antes de prescrbir consulte la pag V1I leyendas

Reg Nm 57575 S S Regs Nums 76549 y 76283 S S

LABORATORIOS MANUELL - A LABORATORIOS RIGERS S A Av del Traoalo Num 237 15270 Mexico 0 F Calle 39 Sur N=m 2208 PueOJ

Marca egstrada

NOTAS Y 0 S U D 0 N A

Suspensldn

Amebicida antiseptico y antiespasm~dico intestinal

FORMULA Cada 100 ml contienen

0ivaOdandro iua no l-a 4 00 g FJr31OIr n I GO g P cna 10 C0

4ent ir Orrv3 = ] Wi nI IVer-cjo -o D3 rr q

INOICACIONES ruhjJ nl isij~rje2 a

f IVIf 3l t lS r f t d ) euro u f -

ANNEX 3

calfurKPIt I -r

colu i

CON SU NUEVA FORMULA

ARA LA DIARREA

oluf urKiP CACLIN yVPECTINA

EL ANTIDIARREICO i-hI4

La clasica f6rmula antidiarr6ica -caolifn y pectina- ejerce una I I accibn astringente y demulcente

libre de todo efecto antimicrobiano adicional

FORMULA Cada 100 ml contienen

Puede usarse conjuntamente con C 19720 gPectina rucos antiinfecciosos cbp 0440en evhiculo 100 ml

tratamiento de las enteritis o POSOLOGIA gastroenteritis bacterianas Para uso oediatric

a--En lactnteso e 2 a 4 cucharaditas en 24 horas

- En preescolares de 4 a 6 cucharaditas en 24 horas

Terapeuticamente at6xico - Adultos de 4 a 6 cucharadas en 24 horas

VIA DE ADMINISTRACION Oral PRESENTACION Frasco con 300 ml REACCIONES SECUNDARIAS Estrerimiento por uso prolongado

Agftese antes de usarse bull Su venta requiere receta medica bull No se dele al alcance de los nirios - Marca Registrada Reg No 026M86 SSA

Hecho 1Med MFE-889J SSA en Mexico

por

CARTER WALLACE SA Prol Ingenieros Militares No 76

11410 Mexico DF

- _ - - - F f W- - - i

- f r -L shyX G -

C 2 - --t - shy

( t i-

rr-

IF~

rk

(9-l i L

I T -c -4- L=r - _ =- _-_---- r Z_=-

-I a t lt - = -

shy - ----~~~~~~~~~JJI5 2

77

TABLETAS SUSPENSION

Efectividad terap6utica Comodidad de administracion

~-4

Lm 4-7F 4

Indica ciones

bull Diarrea aguda infantil

[]E Gastroenteritis

[E Enteritis

beasPosologfa iPresentai~non y fdrmulas

TAB LETAS Cda oeta d neomicina baseSCADA Sulf 3Yo de n ~ uvaet a 125 mg

Metibromuro de homarrooina 2 mg

4p6 6a rra 30mg Caohn 2 0mg Cente cb 1 tableta

- - - - --

Suspension- CADA Furazolidoaa m Frasco con 75 mlCUCHARADITA Cdanic10 a asem

SOSloo de Neomicina equivalente a 0710 g

6 de neomicina 0 gc___ -

HORASude hrnatrina M0015 g Vehiculoe cbp 1- 100ml

Contraindicaclones Enlern dar~es reahc3s sevsra Glaucomal Obstructon ntestinal Pacienres con d~osncria a as comoonenres de 1 m rula

Reacciones sacundarias Resea]ueoad de boca vision borroa estrer imenIosan~~~ORe 0 - - 700gretn Hecro enorMxico y distribumdo

LABORATORIOS SANFER S A de CV

Calzada de 6llpan 550 - 03510Mexco D F

calfurKPIt I -r

colu i

CON SU NUEVA FORMULA

ARA LA DIARREA

oluf urKiP CACLIN yVPECTINA

EL ANTIDIARREICO i-hI4

La clasica f6rmula antidiarr6ica -caolifn y pectina- ejerce una I I accibn astringente y demulcente

libre de todo efecto antimicrobiano adicional

FORMULA Cada 100 ml contienen

Puede usarse conjuntamente con C 19720 gPectina rucos antiinfecciosos cbp 0440en evhiculo 100 ml

tratamiento de las enteritis o POSOLOGIA gastroenteritis bacterianas Para uso oediatric

a--En lactnteso e 2 a 4 cucharaditas en 24 horas

- En preescolares de 4 a 6 cucharaditas en 24 horas

Terapeuticamente at6xico - Adultos de 4 a 6 cucharadas en 24 horas

VIA DE ADMINISTRACION Oral PRESENTACION Frasco con 300 ml REACCIONES SECUNDARIAS Estrerimiento por uso prolongado

Agftese antes de usarse bull Su venta requiere receta medica bull No se dele al alcance de los nirios - Marca Registrada Reg No 026M86 SSA

Hecho 1Med MFE-889J SSA en Mexico

por

CARTER WALLACE SA Prol Ingenieros Militares No 76

11410 Mexico DF

- _ - - - F f W- - - i

- f r -L shyX G -

C 2 - --t - shy

( t i-

rr-

IF~

rk

(9-l i L

I T -c -4- L=r - _ =- _-_---- r Z_=-

-I a t lt - = -

shy - ----~~~~~~~~~JJI5 2

77

TABLETAS SUSPENSION

Efectividad terap6utica Comodidad de administracion

~-4

Lm 4-7F 4

Indica ciones

bull Diarrea aguda infantil

[]E Gastroenteritis

[E Enteritis

beasPosologfa iPresentai~non y fdrmulas

TAB LETAS Cda oeta d neomicina baseSCADA Sulf 3Yo de n ~ uvaet a 125 mg

Metibromuro de homarrooina 2 mg

4p6 6a rra 30mg Caohn 2 0mg Cente cb 1 tableta

- - - - --

Suspension- CADA Furazolidoaa m Frasco con 75 mlCUCHARADITA Cdanic10 a asem

SOSloo de Neomicina equivalente a 0710 g

6 de neomicina 0 gc___ -

HORASude hrnatrina M0015 g Vehiculoe cbp 1- 100ml

Contraindicaclones Enlern dar~es reahc3s sevsra Glaucomal Obstructon ntestinal Pacienres con d~osncria a as comoonenres de 1 m rula

Reacciones sacundarias Resea]ueoad de boca vision borroa estrer imenIosan~~~ORe 0 - - 700gretn Hecro enorMxico y distribumdo

LABORATORIOS SANFER S A de CV

Calzada de 6llpan 550 - 03510Mexco D F

oluf urKiP CACLIN yVPECTINA

EL ANTIDIARREICO i-hI4

La clasica f6rmula antidiarr6ica -caolifn y pectina- ejerce una I I accibn astringente y demulcente

libre de todo efecto antimicrobiano adicional

FORMULA Cada 100 ml contienen

Puede usarse conjuntamente con C 19720 gPectina rucos antiinfecciosos cbp 0440en evhiculo 100 ml

tratamiento de las enteritis o POSOLOGIA gastroenteritis bacterianas Para uso oediatric

a--En lactnteso e 2 a 4 cucharaditas en 24 horas

- En preescolares de 4 a 6 cucharaditas en 24 horas

Terapeuticamente at6xico - Adultos de 4 a 6 cucharadas en 24 horas

VIA DE ADMINISTRACION Oral PRESENTACION Frasco con 300 ml REACCIONES SECUNDARIAS Estrerimiento por uso prolongado

Agftese antes de usarse bull Su venta requiere receta medica bull No se dele al alcance de los nirios - Marca Registrada Reg No 026M86 SSA

Hecho 1Med MFE-889J SSA en Mexico

por

CARTER WALLACE SA Prol Ingenieros Militares No 76

11410 Mexico DF

- _ - - - F f W- - - i

- f r -L shyX G -

C 2 - --t - shy

( t i-

rr-

IF~

rk

(9-l i L

I T -c -4- L=r - _ =- _-_---- r Z_=-

-I a t lt - = -

shy - ----~~~~~~~~~JJI5 2

77

TABLETAS SUSPENSION

Efectividad terap6utica Comodidad de administracion

~-4

Lm 4-7F 4

Indica ciones

bull Diarrea aguda infantil

[]E Gastroenteritis

[E Enteritis

beasPosologfa iPresentai~non y fdrmulas

TAB LETAS Cda oeta d neomicina baseSCADA Sulf 3Yo de n ~ uvaet a 125 mg

Metibromuro de homarrooina 2 mg

4p6 6a rra 30mg Caohn 2 0mg Cente cb 1 tableta

- - - - --

Suspension- CADA Furazolidoaa m Frasco con 75 mlCUCHARADITA Cdanic10 a asem

SOSloo de Neomicina equivalente a 0710 g

6 de neomicina 0 gc___ -

HORASude hrnatrina M0015 g Vehiculoe cbp 1- 100ml

Contraindicaclones Enlern dar~es reahc3s sevsra Glaucomal Obstructon ntestinal Pacienres con d~osncria a as comoonenres de 1 m rula

Reacciones sacundarias Resea]ueoad de boca vision borroa estrer imenIosan~~~ORe 0 - - 700gretn Hecro enorMxico y distribumdo

LABORATORIOS SANFER S A de CV

Calzada de 6llpan 550 - 03510Mexco D F

- _ - - - F f W- - - i

- f r -L shyX G -

C 2 - --t - shy

( t i-

rr-

IF~

rk

(9-l i L

I T -c -4- L=r - _ =- _-_---- r Z_=-

-I a t lt - = -

shy - ----~~~~~~~~~JJI5 2

77

TABLETAS SUSPENSION

Efectividad terap6utica Comodidad de administracion

~-4

Lm 4-7F 4

Indica ciones

bull Diarrea aguda infantil

[]E Gastroenteritis

[E Enteritis

beasPosologfa iPresentai~non y fdrmulas

TAB LETAS Cda oeta d neomicina baseSCADA Sulf 3Yo de n ~ uvaet a 125 mg

Metibromuro de homarrooina 2 mg

4p6 6a rra 30mg Caohn 2 0mg Cente cb 1 tableta

- - - - --

Suspension- CADA Furazolidoaa m Frasco con 75 mlCUCHARADITA Cdanic10 a asem

SOSloo de Neomicina equivalente a 0710 g

6 de neomicina 0 gc___ -

HORASude hrnatrina M0015 g Vehiculoe cbp 1- 100ml

Contraindicaclones Enlern dar~es reahc3s sevsra Glaucomal Obstructon ntestinal Pacienres con d~osncria a as comoonenres de 1 m rula

Reacciones sacundarias Resea]ueoad de boca vision borroa estrer imenIosan~~~ORe 0 - - 700gretn Hecro enorMxico y distribumdo

LABORATORIOS SANFER S A de CV

Calzada de 6llpan 550 - 03510Mexco D F

TABLETAS SUSPENSION

Efectividad terap6utica Comodidad de administracion

~-4

Lm 4-7F 4

Indica ciones

bull Diarrea aguda infantil

[]E Gastroenteritis

[E Enteritis

beasPosologfa iPresentai~non y fdrmulas

TAB LETAS Cda oeta d neomicina baseSCADA Sulf 3Yo de n ~ uvaet a 125 mg

Metibromuro de homarrooina 2 mg

4p6 6a rra 30mg Caohn 2 0mg Cente cb 1 tableta

- - - - --

Suspension- CADA Furazolidoaa m Frasco con 75 mlCUCHARADITA Cdanic10 a asem

SOSloo de Neomicina equivalente a 0710 g

6 de neomicina 0 gc___ -

HORASude hrnatrina M0015 g Vehiculoe cbp 1- 100ml

Contraindicaclones Enlern dar~es reahc3s sevsra Glaucomal Obstructon ntestinal Pacienres con d~osncria a as comoonenres de 1 m rula

Reacciones sacundarias Resea]ueoad de boca vision borroa estrer imenIosan~~~ORe 0 - - 700gretn Hecro enorMxico y distribumdo

LABORATORIOS SANFER S A de CV

Calzada de 6llpan 550 - 03510Mexco D F

7 -

AA

LFi

A4

N- ii

Esti -1- 4J 0 Elemento efica2

diarreas infpcci

Amplio campo Efectos inmedic

Actividad proloi

Grado m6ximo

Dos presentacic suspensi6n

INDICACIONES

Util en el tratamiento de diarrea infecciosa par grmenes gramneshygativos Escherichia Coli Shigella Salmonella por g6rmeneso no especificos FORMULAS Cada c6psula contiene Sulfato de Estreptomicina equivalente a 75 mg de Estreptomicina base Sulfadiazina 200 mgMetilbromuro de pipenzolato 2 mg Excipiente cbp 1c6psula

Cada 100 ml contienen Sulfato de Estreptomicina equivalente a 150 g de Estreptomicina base Sulfadiazina 400 gMetilbromuro de pipenzolato 25 mg Caolin 20 g Pectina g AV

esulfan ANTIDIARREICO

rn el tratamiento de ESTsOSU sas

O-LIaccidn

ada

e tolerancia

e7-C6psulas y

CONTRAINDICACION-ES Personas hipersensibles a alguno de los componentes de la f6rmula glaucoma hipertrofia prost6tica y pil6shyrica

No se administre durante el emborazo ni en nihos menores de 3 meses Este medicamento no deber6 utilizarse por periodos prolongodos sin estricta vigilancia medica Su venta requiere receta medica

REACCIONES SECUNDARIAS En dosis elevadas puede producir crisshytaluria hepatitis t6xica hematuria

PRESENTACIONES C6psulas - caja con 20 Suspensi6n - Envase con 60 ml

DOSIS Adultos 2 a 4 c6psulas C4 hs dependiento del peso Nifos 2 cucharadito por kilo froccionando la dosis c4 hs

Literatura exclusiva parc medicos Reg No 84174 y 84039 SSA I Med LAE-144J

ANTIDIARREICO

bull Elemento eficaz en el tratamiento de diarreas infecciosas

Amplio campo de acci6n

Efectos inmediatos

Actividad prolongoda

Grado meximo de tolercncia

Dos presentaciones C6psulas y Suspensi6n

Laboratorios Infan sa Calz de Tlalpan 4515 Col Toriello Guerra Delegaci6n Tlalpan 14050 M6xico DF

ESTRESULFAN-N C Psulas y Suspension

INSTRUCTIVO

ESTRESULFAN-N es el nombre de uno d e- pi ductos m~s conocidos de los

LABORATORIOS INFAN SA

1- E nombre de ESTRESU-FAN-N recuerdc algc de la f6rmula del producto

El nombre de ESTRESULFAN-N ( forma larmac~utica Cipsulas y Suspen-shy

si6n recuerda alguno de los comppnentes activos de la f6rmula En efecto

Estre se relaciona con el Sulfato de E treptomicina Sul a la Sulfadiashy

zina La terminaci6n Fan tambi~n alude al Labcratorio que lo fabrica

los Laboratorios lnfin SA y el calificativo N indica que es una nueva

f6rmula

2- 6Dentro de qu6 _rupo de productos debe colocarse el producto ESTRESULFAN-

N

El products ESTRESULFAN-N (ff capsulas y suspensi6n) debe agruparse shy

con los medicamentos antidiarr6icos

3- ZQud clase de medicamento es el producto ESTRESULFAN-N

El producto ESTRESULFAN-N es una especialidad farmac~utica indicada en

el tratamiento de las diarreas infecciosas

4- 4 Cuales son las f6rmulas integras del producto ESTRESULFAN-N Cipsulas

y Suspensi6n

ESTRESULFAN -N

C~osulas

FORMTLA Cada capsula conti-r=

Sulfato de estreptomicina equivalente a 75 Mrg

de estrept3micina base

-2shyrgSulfadiazina 200

Metilbromuro de-pipenza-lato 2 rag

Excipiente cbP i caipsula

FRESENTACION Caja con 20 capsulas

ESTRBESULFA N-N Suspensi6 r

FORMAULA Cada 100 Ml contienen

Sulfato de estreptomicina equivalente a 150 g

de estreptomicina base

Sulfadiazina 400 g

Netilbromuro de pipenzolato 25 mg

20C aolin

1 gPectina

100 MIlVehfculo cbp

PRESENTACION Frasco con 60 ml

5 - Cuil es el origen de la Estreptomicina uno de los principios activos shy

del producto ESTRESULFAN - N Cipsulas y Suspensi6n

se obtiene del cultivo de una actinomiceta el Strepto--La Estreptomicina

myces griseus que se encontr6 en el suelo Fue descubierta por Schatz

Bugie y Waksman en 1944 La producci6n industrial se produce partiendo

de cultivos sumergidos en tanques de fermentaci6n extray6ndose la estrep

con disolventes adecuados y sometitomicina previa filtraci6n y absorci6n

ti6 ndose al proceso de purificaci6np--robtener el producto puro pa-ra apli

caci6n en humanos

del Sulfato de Estreptomicina6- Cu6les son las caracterfsticas

Las caracterfsticas del Sulfato de Estreptomicina son las siguientes

--

-3shy

-a) Antibi6ticc de espectro reducido ataca fundamentalmente g~rmenes

Dentro de los gramnegashygramnegativos y uno que otro grampositivo

tivos tenernos Zscherichia coli Haeirop-iois influenzae o bacilo de --

Ffeiffer KIlebsiella pneumoniae o bacilo de Friedlander Fasteurella -

Neisseria gonorrhoeae Shigellaspoestis Basteurella tularensis

son-el Froteus mirabiplusmn1s y Pseudomona aeruginosamenos susceptibles

Sobre algunos grarnpositivos como Bacillus anthracis (catbunco)

Strptococcuspyogenes o Streptococos beta hemolrtico Tiene poco efec

to sobre Strptococcus viridans Streptococcus faecalis y Diplococcus shy

pneumonias o neumococo

De particular importancia es el efecto de la Estreptomicina sobre el

oMycobacterium tuberculosis bacilo de Koch

virus grandes ni pequefiosNo actda sobre espiroquetas Rickettsias

sensibles fundamentalmenb) Tiene efecto bactoricida sobre 103 g6rmenes

te cuando estain en el periodo de multiplicaci6n

por la via oral no se absorbe y toda la estreptomicina quec) Administrado

pone en contacto con los garmenesda en la luz del intestino en donde se

a quienes destruyepat6genos productores de las infecciones diarrdicas

las materias feshyd) La estreptomicina se elirnina por la vfa rectal junto con

cales

e) Como un factor que debe tomarse muy en cuenta en la actividad antimicro

es el pH del medio actuando con mayor potenbiana de la estreptomicina

cia en un medio alcalino y en menor actividad en un pH 6cido

acci6n hasta ahora aceptado se refiere af) El mezanismo de

10 - Alteraci6n de la permeabilidad de la membrana celular

lca dentro de la c~lula bacteriana lo que20 - Inhibiendo la sintesis prot

constituye el mecanisrno principal

-4shy

7 - jQu6 medicamento es la Sulfadiazina

La Sulfadiazina es el prototbipo de las sulfamidas Es un quimioterapico

de origen sintdtico es de las sulfonamida mis antiguas que ha resisshy

tido las prudbas a trav6s del tiempo y continua siendo la sulfa deele shy

ci6n por su efectividad y por su baja toxicidad

8- ZCuales son las caracterrsticas que distinguen a la Sulfadiazina de

otras sulfonamidas

Las caracterrsticas que distinguen a la Sulfadiazina de las otras sulfona shy

midas son

a) Administrada por la via oral es bien tolerada por la rriucosa gastroinshy

testinal

b) Se absorbe la mayor parte por el intestino y muy poca se elimina por

las materias fecales

c) Tiene a-m-plic espectro antibacteriano ataca gdrmenes grampositivos

y gramnegativos

d) Tiene efectobacteriost~itico sobre los g6rmenes sensibles

e) Su actividad sobre los g~rmenes se manifiesta tanto local como en

forma general de ahique al pasar -por el intestino actda sobre los

g~rmenes pat6genos productoresdelas infecciones intestinales esshy

te es el efecti local Al absorbe-se a trav6s de la mucosa irtestishy

nal pasa la la circulaci6n y va a actuar sobre los g~rmenes localishy

zados en otros sitios del organismo ( ejem amigdalas ordos bronshy

quios pulmones) a esto es a lo que se llama acci6n general o acci6n

sist~mica

f) La Sulfadiazina se distribuye en todos los lrquidos y tejidos del orgashy

nismo pero tiene una caracterfstica que consiste en que pasa al liqui

exista o no inshyel 500 de la cantidad que hay en ia sangre

do cefalorraqufdeo

fecci6n de las meninges

se elimina por la via reshyse absorbi6 por cl int stino

g) La Sulf-dia z i n a que

han perdidoforna activa y acetilada ( los metabolitos acetilados

nal en

actividad antibacteriana)

por la admistraci6n de la Sulfadia h) Los trastornos secundarios producidos

el caso particular se man_ a todas las sulfas pero en

zina son comunes

anorexia n~useas v6mitos fiestan por trastorno3 digestivos tales como

el producse continue administrandolo que impide que

gastralgia etx

to

9 ZQu6 medicamento es el Q

silicato de aluminio hidratado que tiene propiedades protecto-El Caolrn es un

en forma de suspensi 6 n por la via oral for ras y absorbentes Administrado

las paredes del est6mago y del intestino quedando ma una capa protectorm a

Entre las propiedades que poseeintestinalprotegida la mucosa gstrica e

shy

el Caolrn podemos citar

gases y toxinasa) Absorbe Irquidos

mucosas secreshyb) Al proteger las paredes del tubo digestivo imnpide que las

el Caolfn ---En resumenpropiedad astringenteten lfquido de ahf su

a absorbentes (absorbe poseelas siguientes propiedades protectoras y shy

el lrquido del intestino shy

y toxinas) astringentes disminuyeagua gases

la materia fecal (antidiar-6ico)aquedando consistencia

posee la Pectina 10 Qud actividad medicamentosa

con un astringente el Cuando la Fectina se adrninistra por via oral asociada

scbre todo cuando el enfermo tie le forma cuerpo a la mnateria fecal

Caolin

ne aumentado el trCnsito intestinal de ahiq ue su uso principal sea en el trashy

tamiento de las diarreas tanto en los nifos como de los adultos ya sea una shy

diarrea simple o por infecci6n

11 61u6 propiedades tiene el Metilbrornuro de Pipenzolato

Aetilbromuro de -ipenzolato es un medicamento sint~tico anticolindrgico

cuyos efectos recuerdan las acciones perif~ricas de la atropina Produce -shy

-un efecto antisecretor gastrico asi como una disrninuci6n de la inotilidad

-intestinal Tiene un efecto antiespasm6dico sobre la fibra muscular lisa

del tracto biliar lIMetilbromuro de Pipenzolato quita el espasmo del

tracto gastrointestinal inferior asf como el del esfinter de Oddi y puede -shy

el sindrome del colon irritable -shyser Util en el tratamiento de la ileitis en

y en otros trastornos funcionales de los tractos gastrointestinal y biliar

12 ZCu6l es la acci6n farmacol6gica del producto ESTRESULFAN - N

es el resultado deLa acci6n farmacol6gica del producto ESTRESULFAN-N

la acci6n farmacodinrnica de cada uno de los principios activos que entran

a formar parte de la f6rmula El Sulfato de Estreptornicina antibi6tico de

que actdia sobre g6rrnenes gramnegativos principairnentepequefno espectro

con efecto bactericida sobre los microorganismos productores de las infecshy

ciones y de las diarreas La Sulfadiazina un quimiotergpico de acci6n

que ataca a los pat6genos productores de -shybacteriost~tica local y general

Estos dos antirnicrobianos son sindrgicos -shylas infeccio-es del intestino

lleva a cabo su acci6n bactericidaen su acci6n ya que la Estreptonnicina

sobr -o= g-rrn-Tn e - -t6genos porque interviene alterando la permeabilidad

de la rnembrana celular v el rnetabolisrno de las proteffnas en tanto que la

con el cido para-amin3benzoico en la formaci6n del -Sulfadiazina compite (l)

acido f6lico indispensable para la sobrevida de los ricroorganis-=s 51 Ileshy

tilboruro de Pipenzolato es un anticolinfrgico que disminuye las secreciones

del est6mago y la motilidad intestinal del tracto -igestivo quitandc los espasmos

en la fibra muscular lisa del intestino EI Caolin con sus propiedades protectoshy

la materiaras absorb~ntes v astringentes y la -ectina que le forma cuerpo a

fecal hacen al producto ESTRESULFAiN-N urna aziacion sinrgica para elshy

de los niilos o de los adultos (La formatratamiento de las dia-rreas infecciosas

lleva Caolfn ni Fectinafarmac4utica Capsulas no

13 LEn qu6 enfermedades esta indicado el producto ESTRESULFAN-N Capsu-shy

las y Suspensi6n

en ----El producto ESTRESULFAN-N Capsulas y Suspensi6n esta indicado

tratamiento de padecimientos del aparato digestivo en particular en las inshy

fecciones intestinalez que se acompafien de diarreas producidas por gdrmeshy

tales como Diarreas del nes sensibles a los antimicrobianos de la f6rmula

lactante de nifics o bi~n de los adultos producidas por Escherichia coli shy

etcSalmonellas Shigellas Staphylococcus aureus Streptococcus faecalis

14 ZC6mo se presenta al pdblico el producto ESTRESULFAN-N

El producto ESTRESULFANN-N se presenta al pdblico en dos formas farma-shy

con 30 mlc~utidas Capsulas y Suspensi6n Caja con 20 c 4psulas y Frasco

en forma de suspensi6n Una cucharadita de 5 ml de la suspensi6n tiene --

LCo i- 3- oulfai -zin y 75 de Sulfato de 7streptomicina

qu6 dosis se recornienda administra-r e] producto BSTRESULFAN-N15 zA

horas dependianto del pesoAdultos 2 a 4 cipsulas cada 4

peso por dra fraccionandcNinos 12 cucharadita de Suspensicn por kilo de

la dosis y administrindola cada 4 hcras

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

Esti -1- 4J 0 Elemento efica2

diarreas infpcci

Amplio campo Efectos inmedic

Actividad proloi

Grado m6ximo

Dos presentacic suspensi6n

INDICACIONES

Util en el tratamiento de diarrea infecciosa par grmenes gramneshygativos Escherichia Coli Shigella Salmonella por g6rmeneso no especificos FORMULAS Cada c6psula contiene Sulfato de Estreptomicina equivalente a 75 mg de Estreptomicina base Sulfadiazina 200 mgMetilbromuro de pipenzolato 2 mg Excipiente cbp 1c6psula

Cada 100 ml contienen Sulfato de Estreptomicina equivalente a 150 g de Estreptomicina base Sulfadiazina 400 gMetilbromuro de pipenzolato 25 mg Caolin 20 g Pectina g AV

esulfan ANTIDIARREICO

rn el tratamiento de ESTsOSU sas

O-LIaccidn

ada

e tolerancia

e7-C6psulas y

CONTRAINDICACION-ES Personas hipersensibles a alguno de los componentes de la f6rmula glaucoma hipertrofia prost6tica y pil6shyrica

No se administre durante el emborazo ni en nihos menores de 3 meses Este medicamento no deber6 utilizarse por periodos prolongodos sin estricta vigilancia medica Su venta requiere receta medica

REACCIONES SECUNDARIAS En dosis elevadas puede producir crisshytaluria hepatitis t6xica hematuria

PRESENTACIONES C6psulas - caja con 20 Suspensi6n - Envase con 60 ml

DOSIS Adultos 2 a 4 c6psulas C4 hs dependiento del peso Nifos 2 cucharadito por kilo froccionando la dosis c4 hs

Literatura exclusiva parc medicos Reg No 84174 y 84039 SSA I Med LAE-144J

ANTIDIARREICO

bull Elemento eficaz en el tratamiento de diarreas infecciosas

Amplio campo de acci6n

Efectos inmediatos

Actividad prolongoda

Grado meximo de tolercncia

Dos presentaciones C6psulas y Suspensi6n

Laboratorios Infan sa Calz de Tlalpan 4515 Col Toriello Guerra Delegaci6n Tlalpan 14050 M6xico DF

ESTRESULFAN-N C Psulas y Suspension

INSTRUCTIVO

ESTRESULFAN-N es el nombre de uno d e- pi ductos m~s conocidos de los

LABORATORIOS INFAN SA

1- E nombre de ESTRESU-FAN-N recuerdc algc de la f6rmula del producto

El nombre de ESTRESULFAN-N ( forma larmac~utica Cipsulas y Suspen-shy

si6n recuerda alguno de los comppnentes activos de la f6rmula En efecto

Estre se relaciona con el Sulfato de E treptomicina Sul a la Sulfadiashy

zina La terminaci6n Fan tambi~n alude al Labcratorio que lo fabrica

los Laboratorios lnfin SA y el calificativo N indica que es una nueva

f6rmula

2- 6Dentro de qu6 _rupo de productos debe colocarse el producto ESTRESULFAN-

N

El products ESTRESULFAN-N (ff capsulas y suspensi6n) debe agruparse shy

con los medicamentos antidiarr6icos

3- ZQud clase de medicamento es el producto ESTRESULFAN-N

El producto ESTRESULFAN-N es una especialidad farmac~utica indicada en

el tratamiento de las diarreas infecciosas

4- 4 Cuales son las f6rmulas integras del producto ESTRESULFAN-N Cipsulas

y Suspensi6n

ESTRESULFAN -N

C~osulas

FORMTLA Cada capsula conti-r=

Sulfato de estreptomicina equivalente a 75 Mrg

de estrept3micina base

-2shyrgSulfadiazina 200

Metilbromuro de-pipenza-lato 2 rag

Excipiente cbP i caipsula

FRESENTACION Caja con 20 capsulas

ESTRBESULFA N-N Suspensi6 r

FORMAULA Cada 100 Ml contienen

Sulfato de estreptomicina equivalente a 150 g

de estreptomicina base

Sulfadiazina 400 g

Netilbromuro de pipenzolato 25 mg

20C aolin

1 gPectina

100 MIlVehfculo cbp

PRESENTACION Frasco con 60 ml

5 - Cuil es el origen de la Estreptomicina uno de los principios activos shy

del producto ESTRESULFAN - N Cipsulas y Suspensi6n

se obtiene del cultivo de una actinomiceta el Strepto--La Estreptomicina

myces griseus que se encontr6 en el suelo Fue descubierta por Schatz

Bugie y Waksman en 1944 La producci6n industrial se produce partiendo

de cultivos sumergidos en tanques de fermentaci6n extray6ndose la estrep

con disolventes adecuados y sometitomicina previa filtraci6n y absorci6n

ti6 ndose al proceso de purificaci6np--robtener el producto puro pa-ra apli

caci6n en humanos

del Sulfato de Estreptomicina6- Cu6les son las caracterfsticas

Las caracterfsticas del Sulfato de Estreptomicina son las siguientes

--

-3shy

-a) Antibi6ticc de espectro reducido ataca fundamentalmente g~rmenes

Dentro de los gramnegashygramnegativos y uno que otro grampositivo

tivos tenernos Zscherichia coli Haeirop-iois influenzae o bacilo de --

Ffeiffer KIlebsiella pneumoniae o bacilo de Friedlander Fasteurella -

Neisseria gonorrhoeae Shigellaspoestis Basteurella tularensis

son-el Froteus mirabiplusmn1s y Pseudomona aeruginosamenos susceptibles

Sobre algunos grarnpositivos como Bacillus anthracis (catbunco)

Strptococcuspyogenes o Streptococos beta hemolrtico Tiene poco efec

to sobre Strptococcus viridans Streptococcus faecalis y Diplococcus shy

pneumonias o neumococo

De particular importancia es el efecto de la Estreptomicina sobre el

oMycobacterium tuberculosis bacilo de Koch

virus grandes ni pequefiosNo actda sobre espiroquetas Rickettsias

sensibles fundamentalmenb) Tiene efecto bactoricida sobre 103 g6rmenes

te cuando estain en el periodo de multiplicaci6n

por la via oral no se absorbe y toda la estreptomicina quec) Administrado

pone en contacto con los garmenesda en la luz del intestino en donde se

a quienes destruyepat6genos productores de las infecciones diarrdicas

las materias feshyd) La estreptomicina se elirnina por la vfa rectal junto con

cales

e) Como un factor que debe tomarse muy en cuenta en la actividad antimicro

es el pH del medio actuando con mayor potenbiana de la estreptomicina

cia en un medio alcalino y en menor actividad en un pH 6cido

acci6n hasta ahora aceptado se refiere af) El mezanismo de

10 - Alteraci6n de la permeabilidad de la membrana celular

lca dentro de la c~lula bacteriana lo que20 - Inhibiendo la sintesis prot

constituye el mecanisrno principal

-4shy

7 - jQu6 medicamento es la Sulfadiazina

La Sulfadiazina es el prototbipo de las sulfamidas Es un quimioterapico

de origen sintdtico es de las sulfonamida mis antiguas que ha resisshy

tido las prudbas a trav6s del tiempo y continua siendo la sulfa deele shy

ci6n por su efectividad y por su baja toxicidad

8- ZCuales son las caracterrsticas que distinguen a la Sulfadiazina de

otras sulfonamidas

Las caracterrsticas que distinguen a la Sulfadiazina de las otras sulfona shy

midas son

a) Administrada por la via oral es bien tolerada por la rriucosa gastroinshy

testinal

b) Se absorbe la mayor parte por el intestino y muy poca se elimina por

las materias fecales

c) Tiene a-m-plic espectro antibacteriano ataca gdrmenes grampositivos

y gramnegativos

d) Tiene efectobacteriost~itico sobre los g6rmenes sensibles

e) Su actividad sobre los g~rmenes se manifiesta tanto local como en

forma general de ahique al pasar -por el intestino actda sobre los

g~rmenes pat6genos productoresdelas infecciones intestinales esshy

te es el efecti local Al absorbe-se a trav6s de la mucosa irtestishy

nal pasa la la circulaci6n y va a actuar sobre los g~rmenes localishy

zados en otros sitios del organismo ( ejem amigdalas ordos bronshy

quios pulmones) a esto es a lo que se llama acci6n general o acci6n

sist~mica

f) La Sulfadiazina se distribuye en todos los lrquidos y tejidos del orgashy

nismo pero tiene una caracterfstica que consiste en que pasa al liqui

exista o no inshyel 500 de la cantidad que hay en ia sangre

do cefalorraqufdeo

fecci6n de las meninges

se elimina por la via reshyse absorbi6 por cl int stino

g) La Sulf-dia z i n a que

han perdidoforna activa y acetilada ( los metabolitos acetilados

nal en

actividad antibacteriana)

por la admistraci6n de la Sulfadia h) Los trastornos secundarios producidos

el caso particular se man_ a todas las sulfas pero en

zina son comunes

anorexia n~useas v6mitos fiestan por trastorno3 digestivos tales como

el producse continue administrandolo que impide que

gastralgia etx

to

9 ZQu6 medicamento es el Q

silicato de aluminio hidratado que tiene propiedades protecto-El Caolrn es un

en forma de suspensi 6 n por la via oral for ras y absorbentes Administrado

las paredes del est6mago y del intestino quedando ma una capa protectorm a

Entre las propiedades que poseeintestinalprotegida la mucosa gstrica e

shy

el Caolrn podemos citar

gases y toxinasa) Absorbe Irquidos

mucosas secreshyb) Al proteger las paredes del tubo digestivo imnpide que las

el Caolfn ---En resumenpropiedad astringenteten lfquido de ahf su

a absorbentes (absorbe poseelas siguientes propiedades protectoras y shy

el lrquido del intestino shy

y toxinas) astringentes disminuyeagua gases

la materia fecal (antidiar-6ico)aquedando consistencia

posee la Pectina 10 Qud actividad medicamentosa

con un astringente el Cuando la Fectina se adrninistra por via oral asociada

scbre todo cuando el enfermo tie le forma cuerpo a la mnateria fecal

Caolin

ne aumentado el trCnsito intestinal de ahiq ue su uso principal sea en el trashy

tamiento de las diarreas tanto en los nifos como de los adultos ya sea una shy

diarrea simple o por infecci6n

11 61u6 propiedades tiene el Metilbrornuro de Pipenzolato

Aetilbromuro de -ipenzolato es un medicamento sint~tico anticolindrgico

cuyos efectos recuerdan las acciones perif~ricas de la atropina Produce -shy

-un efecto antisecretor gastrico asi como una disrninuci6n de la inotilidad

-intestinal Tiene un efecto antiespasm6dico sobre la fibra muscular lisa

del tracto biliar lIMetilbromuro de Pipenzolato quita el espasmo del

tracto gastrointestinal inferior asf como el del esfinter de Oddi y puede -shy

el sindrome del colon irritable -shyser Util en el tratamiento de la ileitis en

y en otros trastornos funcionales de los tractos gastrointestinal y biliar

12 ZCu6l es la acci6n farmacol6gica del producto ESTRESULFAN - N

es el resultado deLa acci6n farmacol6gica del producto ESTRESULFAN-N

la acci6n farmacodinrnica de cada uno de los principios activos que entran

a formar parte de la f6rmula El Sulfato de Estreptornicina antibi6tico de

que actdia sobre g6rrnenes gramnegativos principairnentepequefno espectro

con efecto bactericida sobre los microorganismos productores de las infecshy

ciones y de las diarreas La Sulfadiazina un quimiotergpico de acci6n

que ataca a los pat6genos productores de -shybacteriost~tica local y general

Estos dos antirnicrobianos son sindrgicos -shylas infeccio-es del intestino

lleva a cabo su acci6n bactericidaen su acci6n ya que la Estreptonnicina

sobr -o= g-rrn-Tn e - -t6genos porque interviene alterando la permeabilidad

de la rnembrana celular v el rnetabolisrno de las proteffnas en tanto que la

con el cido para-amin3benzoico en la formaci6n del -Sulfadiazina compite (l)

acido f6lico indispensable para la sobrevida de los ricroorganis-=s 51 Ileshy

tilboruro de Pipenzolato es un anticolinfrgico que disminuye las secreciones

del est6mago y la motilidad intestinal del tracto -igestivo quitandc los espasmos

en la fibra muscular lisa del intestino EI Caolin con sus propiedades protectoshy

la materiaras absorb~ntes v astringentes y la -ectina que le forma cuerpo a

fecal hacen al producto ESTRESULFAiN-N urna aziacion sinrgica para elshy

de los niilos o de los adultos (La formatratamiento de las dia-rreas infecciosas

lleva Caolfn ni Fectinafarmac4utica Capsulas no

13 LEn qu6 enfermedades esta indicado el producto ESTRESULFAN-N Capsu-shy

las y Suspensi6n

en ----El producto ESTRESULFAN-N Capsulas y Suspensi6n esta indicado

tratamiento de padecimientos del aparato digestivo en particular en las inshy

fecciones intestinalez que se acompafien de diarreas producidas por gdrmeshy

tales como Diarreas del nes sensibles a los antimicrobianos de la f6rmula

lactante de nifics o bi~n de los adultos producidas por Escherichia coli shy

etcSalmonellas Shigellas Staphylococcus aureus Streptococcus faecalis

14 ZC6mo se presenta al pdblico el producto ESTRESULFAN-N

El producto ESTRESULFANN-N se presenta al pdblico en dos formas farma-shy

con 30 mlc~utidas Capsulas y Suspensi6n Caja con 20 c 4psulas y Frasco

en forma de suspensi6n Una cucharadita de 5 ml de la suspensi6n tiene --

LCo i- 3- oulfai -zin y 75 de Sulfato de 7streptomicina

qu6 dosis se recornienda administra-r e] producto BSTRESULFAN-N15 zA

horas dependianto del pesoAdultos 2 a 4 cipsulas cada 4

peso por dra fraccionandcNinos 12 cucharadita de Suspensicn por kilo de

la dosis y administrindola cada 4 hcras

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

esulfan ANTIDIARREICO

rn el tratamiento de ESTsOSU sas

O-LIaccidn

ada

e tolerancia

e7-C6psulas y

CONTRAINDICACION-ES Personas hipersensibles a alguno de los componentes de la f6rmula glaucoma hipertrofia prost6tica y pil6shyrica

No se administre durante el emborazo ni en nihos menores de 3 meses Este medicamento no deber6 utilizarse por periodos prolongodos sin estricta vigilancia medica Su venta requiere receta medica

REACCIONES SECUNDARIAS En dosis elevadas puede producir crisshytaluria hepatitis t6xica hematuria

PRESENTACIONES C6psulas - caja con 20 Suspensi6n - Envase con 60 ml

DOSIS Adultos 2 a 4 c6psulas C4 hs dependiento del peso Nifos 2 cucharadito por kilo froccionando la dosis c4 hs

Literatura exclusiva parc medicos Reg No 84174 y 84039 SSA I Med LAE-144J

ANTIDIARREICO

bull Elemento eficaz en el tratamiento de diarreas infecciosas

Amplio campo de acci6n

Efectos inmediatos

Actividad prolongoda

Grado meximo de tolercncia

Dos presentaciones C6psulas y Suspensi6n

Laboratorios Infan sa Calz de Tlalpan 4515 Col Toriello Guerra Delegaci6n Tlalpan 14050 M6xico DF

ESTRESULFAN-N C Psulas y Suspension

INSTRUCTIVO

ESTRESULFAN-N es el nombre de uno d e- pi ductos m~s conocidos de los

LABORATORIOS INFAN SA

1- E nombre de ESTRESU-FAN-N recuerdc algc de la f6rmula del producto

El nombre de ESTRESULFAN-N ( forma larmac~utica Cipsulas y Suspen-shy

si6n recuerda alguno de los comppnentes activos de la f6rmula En efecto

Estre se relaciona con el Sulfato de E treptomicina Sul a la Sulfadiashy

zina La terminaci6n Fan tambi~n alude al Labcratorio que lo fabrica

los Laboratorios lnfin SA y el calificativo N indica que es una nueva

f6rmula

2- 6Dentro de qu6 _rupo de productos debe colocarse el producto ESTRESULFAN-

N

El products ESTRESULFAN-N (ff capsulas y suspensi6n) debe agruparse shy

con los medicamentos antidiarr6icos

3- ZQud clase de medicamento es el producto ESTRESULFAN-N

El producto ESTRESULFAN-N es una especialidad farmac~utica indicada en

el tratamiento de las diarreas infecciosas

4- 4 Cuales son las f6rmulas integras del producto ESTRESULFAN-N Cipsulas

y Suspensi6n

ESTRESULFAN -N

C~osulas

FORMTLA Cada capsula conti-r=

Sulfato de estreptomicina equivalente a 75 Mrg

de estrept3micina base

-2shyrgSulfadiazina 200

Metilbromuro de-pipenza-lato 2 rag

Excipiente cbP i caipsula

FRESENTACION Caja con 20 capsulas

ESTRBESULFA N-N Suspensi6 r

FORMAULA Cada 100 Ml contienen

Sulfato de estreptomicina equivalente a 150 g

de estreptomicina base

Sulfadiazina 400 g

Netilbromuro de pipenzolato 25 mg

20C aolin

1 gPectina

100 MIlVehfculo cbp

PRESENTACION Frasco con 60 ml

5 - Cuil es el origen de la Estreptomicina uno de los principios activos shy

del producto ESTRESULFAN - N Cipsulas y Suspensi6n

se obtiene del cultivo de una actinomiceta el Strepto--La Estreptomicina

myces griseus que se encontr6 en el suelo Fue descubierta por Schatz

Bugie y Waksman en 1944 La producci6n industrial se produce partiendo

de cultivos sumergidos en tanques de fermentaci6n extray6ndose la estrep

con disolventes adecuados y sometitomicina previa filtraci6n y absorci6n

ti6 ndose al proceso de purificaci6np--robtener el producto puro pa-ra apli

caci6n en humanos

del Sulfato de Estreptomicina6- Cu6les son las caracterfsticas

Las caracterfsticas del Sulfato de Estreptomicina son las siguientes

--

-3shy

-a) Antibi6ticc de espectro reducido ataca fundamentalmente g~rmenes

Dentro de los gramnegashygramnegativos y uno que otro grampositivo

tivos tenernos Zscherichia coli Haeirop-iois influenzae o bacilo de --

Ffeiffer KIlebsiella pneumoniae o bacilo de Friedlander Fasteurella -

Neisseria gonorrhoeae Shigellaspoestis Basteurella tularensis

son-el Froteus mirabiplusmn1s y Pseudomona aeruginosamenos susceptibles

Sobre algunos grarnpositivos como Bacillus anthracis (catbunco)

Strptococcuspyogenes o Streptococos beta hemolrtico Tiene poco efec

to sobre Strptococcus viridans Streptococcus faecalis y Diplococcus shy

pneumonias o neumococo

De particular importancia es el efecto de la Estreptomicina sobre el

oMycobacterium tuberculosis bacilo de Koch

virus grandes ni pequefiosNo actda sobre espiroquetas Rickettsias

sensibles fundamentalmenb) Tiene efecto bactoricida sobre 103 g6rmenes

te cuando estain en el periodo de multiplicaci6n

por la via oral no se absorbe y toda la estreptomicina quec) Administrado

pone en contacto con los garmenesda en la luz del intestino en donde se

a quienes destruyepat6genos productores de las infecciones diarrdicas

las materias feshyd) La estreptomicina se elirnina por la vfa rectal junto con

cales

e) Como un factor que debe tomarse muy en cuenta en la actividad antimicro

es el pH del medio actuando con mayor potenbiana de la estreptomicina

cia en un medio alcalino y en menor actividad en un pH 6cido

acci6n hasta ahora aceptado se refiere af) El mezanismo de

10 - Alteraci6n de la permeabilidad de la membrana celular

lca dentro de la c~lula bacteriana lo que20 - Inhibiendo la sintesis prot

constituye el mecanisrno principal

-4shy

7 - jQu6 medicamento es la Sulfadiazina

La Sulfadiazina es el prototbipo de las sulfamidas Es un quimioterapico

de origen sintdtico es de las sulfonamida mis antiguas que ha resisshy

tido las prudbas a trav6s del tiempo y continua siendo la sulfa deele shy

ci6n por su efectividad y por su baja toxicidad

8- ZCuales son las caracterrsticas que distinguen a la Sulfadiazina de

otras sulfonamidas

Las caracterrsticas que distinguen a la Sulfadiazina de las otras sulfona shy

midas son

a) Administrada por la via oral es bien tolerada por la rriucosa gastroinshy

testinal

b) Se absorbe la mayor parte por el intestino y muy poca se elimina por

las materias fecales

c) Tiene a-m-plic espectro antibacteriano ataca gdrmenes grampositivos

y gramnegativos

d) Tiene efectobacteriost~itico sobre los g6rmenes sensibles

e) Su actividad sobre los g~rmenes se manifiesta tanto local como en

forma general de ahique al pasar -por el intestino actda sobre los

g~rmenes pat6genos productoresdelas infecciones intestinales esshy

te es el efecti local Al absorbe-se a trav6s de la mucosa irtestishy

nal pasa la la circulaci6n y va a actuar sobre los g~rmenes localishy

zados en otros sitios del organismo ( ejem amigdalas ordos bronshy

quios pulmones) a esto es a lo que se llama acci6n general o acci6n

sist~mica

f) La Sulfadiazina se distribuye en todos los lrquidos y tejidos del orgashy

nismo pero tiene una caracterfstica que consiste en que pasa al liqui

exista o no inshyel 500 de la cantidad que hay en ia sangre

do cefalorraqufdeo

fecci6n de las meninges

se elimina por la via reshyse absorbi6 por cl int stino

g) La Sulf-dia z i n a que

han perdidoforna activa y acetilada ( los metabolitos acetilados

nal en

actividad antibacteriana)

por la admistraci6n de la Sulfadia h) Los trastornos secundarios producidos

el caso particular se man_ a todas las sulfas pero en

zina son comunes

anorexia n~useas v6mitos fiestan por trastorno3 digestivos tales como

el producse continue administrandolo que impide que

gastralgia etx

to

9 ZQu6 medicamento es el Q

silicato de aluminio hidratado que tiene propiedades protecto-El Caolrn es un

en forma de suspensi 6 n por la via oral for ras y absorbentes Administrado

las paredes del est6mago y del intestino quedando ma una capa protectorm a

Entre las propiedades que poseeintestinalprotegida la mucosa gstrica e

shy

el Caolrn podemos citar

gases y toxinasa) Absorbe Irquidos

mucosas secreshyb) Al proteger las paredes del tubo digestivo imnpide que las

el Caolfn ---En resumenpropiedad astringenteten lfquido de ahf su

a absorbentes (absorbe poseelas siguientes propiedades protectoras y shy

el lrquido del intestino shy

y toxinas) astringentes disminuyeagua gases

la materia fecal (antidiar-6ico)aquedando consistencia

posee la Pectina 10 Qud actividad medicamentosa

con un astringente el Cuando la Fectina se adrninistra por via oral asociada

scbre todo cuando el enfermo tie le forma cuerpo a la mnateria fecal

Caolin

ne aumentado el trCnsito intestinal de ahiq ue su uso principal sea en el trashy

tamiento de las diarreas tanto en los nifos como de los adultos ya sea una shy

diarrea simple o por infecci6n

11 61u6 propiedades tiene el Metilbrornuro de Pipenzolato

Aetilbromuro de -ipenzolato es un medicamento sint~tico anticolindrgico

cuyos efectos recuerdan las acciones perif~ricas de la atropina Produce -shy

-un efecto antisecretor gastrico asi como una disrninuci6n de la inotilidad

-intestinal Tiene un efecto antiespasm6dico sobre la fibra muscular lisa

del tracto biliar lIMetilbromuro de Pipenzolato quita el espasmo del

tracto gastrointestinal inferior asf como el del esfinter de Oddi y puede -shy

el sindrome del colon irritable -shyser Util en el tratamiento de la ileitis en

y en otros trastornos funcionales de los tractos gastrointestinal y biliar

12 ZCu6l es la acci6n farmacol6gica del producto ESTRESULFAN - N

es el resultado deLa acci6n farmacol6gica del producto ESTRESULFAN-N

la acci6n farmacodinrnica de cada uno de los principios activos que entran

a formar parte de la f6rmula El Sulfato de Estreptornicina antibi6tico de

que actdia sobre g6rrnenes gramnegativos principairnentepequefno espectro

con efecto bactericida sobre los microorganismos productores de las infecshy

ciones y de las diarreas La Sulfadiazina un quimiotergpico de acci6n

que ataca a los pat6genos productores de -shybacteriost~tica local y general

Estos dos antirnicrobianos son sindrgicos -shylas infeccio-es del intestino

lleva a cabo su acci6n bactericidaen su acci6n ya que la Estreptonnicina

sobr -o= g-rrn-Tn e - -t6genos porque interviene alterando la permeabilidad

de la rnembrana celular v el rnetabolisrno de las proteffnas en tanto que la

con el cido para-amin3benzoico en la formaci6n del -Sulfadiazina compite (l)

acido f6lico indispensable para la sobrevida de los ricroorganis-=s 51 Ileshy

tilboruro de Pipenzolato es un anticolinfrgico que disminuye las secreciones

del est6mago y la motilidad intestinal del tracto -igestivo quitandc los espasmos

en la fibra muscular lisa del intestino EI Caolin con sus propiedades protectoshy

la materiaras absorb~ntes v astringentes y la -ectina que le forma cuerpo a

fecal hacen al producto ESTRESULFAiN-N urna aziacion sinrgica para elshy

de los niilos o de los adultos (La formatratamiento de las dia-rreas infecciosas

lleva Caolfn ni Fectinafarmac4utica Capsulas no

13 LEn qu6 enfermedades esta indicado el producto ESTRESULFAN-N Capsu-shy

las y Suspensi6n

en ----El producto ESTRESULFAN-N Capsulas y Suspensi6n esta indicado

tratamiento de padecimientos del aparato digestivo en particular en las inshy

fecciones intestinalez que se acompafien de diarreas producidas por gdrmeshy

tales como Diarreas del nes sensibles a los antimicrobianos de la f6rmula

lactante de nifics o bi~n de los adultos producidas por Escherichia coli shy

etcSalmonellas Shigellas Staphylococcus aureus Streptococcus faecalis

14 ZC6mo se presenta al pdblico el producto ESTRESULFAN-N

El producto ESTRESULFANN-N se presenta al pdblico en dos formas farma-shy

con 30 mlc~utidas Capsulas y Suspensi6n Caja con 20 c 4psulas y Frasco

en forma de suspensi6n Una cucharadita de 5 ml de la suspensi6n tiene --

LCo i- 3- oulfai -zin y 75 de Sulfato de 7streptomicina

qu6 dosis se recornienda administra-r e] producto BSTRESULFAN-N15 zA

horas dependianto del pesoAdultos 2 a 4 cipsulas cada 4

peso por dra fraccionandcNinos 12 cucharadita de Suspensicn por kilo de

la dosis y administrindola cada 4 hcras

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

ANTIDIARREICO

bull Elemento eficaz en el tratamiento de diarreas infecciosas

Amplio campo de acci6n

Efectos inmediatos

Actividad prolongoda

Grado meximo de tolercncia

Dos presentaciones C6psulas y Suspensi6n

Laboratorios Infan sa Calz de Tlalpan 4515 Col Toriello Guerra Delegaci6n Tlalpan 14050 M6xico DF

ESTRESULFAN-N C Psulas y Suspension

INSTRUCTIVO

ESTRESULFAN-N es el nombre de uno d e- pi ductos m~s conocidos de los

LABORATORIOS INFAN SA

1- E nombre de ESTRESU-FAN-N recuerdc algc de la f6rmula del producto

El nombre de ESTRESULFAN-N ( forma larmac~utica Cipsulas y Suspen-shy

si6n recuerda alguno de los comppnentes activos de la f6rmula En efecto

Estre se relaciona con el Sulfato de E treptomicina Sul a la Sulfadiashy

zina La terminaci6n Fan tambi~n alude al Labcratorio que lo fabrica

los Laboratorios lnfin SA y el calificativo N indica que es una nueva

f6rmula

2- 6Dentro de qu6 _rupo de productos debe colocarse el producto ESTRESULFAN-

N

El products ESTRESULFAN-N (ff capsulas y suspensi6n) debe agruparse shy

con los medicamentos antidiarr6icos

3- ZQud clase de medicamento es el producto ESTRESULFAN-N

El producto ESTRESULFAN-N es una especialidad farmac~utica indicada en

el tratamiento de las diarreas infecciosas

4- 4 Cuales son las f6rmulas integras del producto ESTRESULFAN-N Cipsulas

y Suspensi6n

ESTRESULFAN -N

C~osulas

FORMTLA Cada capsula conti-r=

Sulfato de estreptomicina equivalente a 75 Mrg

de estrept3micina base

-2shyrgSulfadiazina 200

Metilbromuro de-pipenza-lato 2 rag

Excipiente cbP i caipsula

FRESENTACION Caja con 20 capsulas

ESTRBESULFA N-N Suspensi6 r

FORMAULA Cada 100 Ml contienen

Sulfato de estreptomicina equivalente a 150 g

de estreptomicina base

Sulfadiazina 400 g

Netilbromuro de pipenzolato 25 mg

20C aolin

1 gPectina

100 MIlVehfculo cbp

PRESENTACION Frasco con 60 ml

5 - Cuil es el origen de la Estreptomicina uno de los principios activos shy

del producto ESTRESULFAN - N Cipsulas y Suspensi6n

se obtiene del cultivo de una actinomiceta el Strepto--La Estreptomicina

myces griseus que se encontr6 en el suelo Fue descubierta por Schatz

Bugie y Waksman en 1944 La producci6n industrial se produce partiendo

de cultivos sumergidos en tanques de fermentaci6n extray6ndose la estrep

con disolventes adecuados y sometitomicina previa filtraci6n y absorci6n

ti6 ndose al proceso de purificaci6np--robtener el producto puro pa-ra apli

caci6n en humanos

del Sulfato de Estreptomicina6- Cu6les son las caracterfsticas

Las caracterfsticas del Sulfato de Estreptomicina son las siguientes

--

-3shy

-a) Antibi6ticc de espectro reducido ataca fundamentalmente g~rmenes

Dentro de los gramnegashygramnegativos y uno que otro grampositivo

tivos tenernos Zscherichia coli Haeirop-iois influenzae o bacilo de --

Ffeiffer KIlebsiella pneumoniae o bacilo de Friedlander Fasteurella -

Neisseria gonorrhoeae Shigellaspoestis Basteurella tularensis

son-el Froteus mirabiplusmn1s y Pseudomona aeruginosamenos susceptibles

Sobre algunos grarnpositivos como Bacillus anthracis (catbunco)

Strptococcuspyogenes o Streptococos beta hemolrtico Tiene poco efec

to sobre Strptococcus viridans Streptococcus faecalis y Diplococcus shy

pneumonias o neumococo

De particular importancia es el efecto de la Estreptomicina sobre el

oMycobacterium tuberculosis bacilo de Koch

virus grandes ni pequefiosNo actda sobre espiroquetas Rickettsias

sensibles fundamentalmenb) Tiene efecto bactoricida sobre 103 g6rmenes

te cuando estain en el periodo de multiplicaci6n

por la via oral no se absorbe y toda la estreptomicina quec) Administrado

pone en contacto con los garmenesda en la luz del intestino en donde se

a quienes destruyepat6genos productores de las infecciones diarrdicas

las materias feshyd) La estreptomicina se elirnina por la vfa rectal junto con

cales

e) Como un factor que debe tomarse muy en cuenta en la actividad antimicro

es el pH del medio actuando con mayor potenbiana de la estreptomicina

cia en un medio alcalino y en menor actividad en un pH 6cido

acci6n hasta ahora aceptado se refiere af) El mezanismo de

10 - Alteraci6n de la permeabilidad de la membrana celular

lca dentro de la c~lula bacteriana lo que20 - Inhibiendo la sintesis prot

constituye el mecanisrno principal

-4shy

7 - jQu6 medicamento es la Sulfadiazina

La Sulfadiazina es el prototbipo de las sulfamidas Es un quimioterapico

de origen sintdtico es de las sulfonamida mis antiguas que ha resisshy

tido las prudbas a trav6s del tiempo y continua siendo la sulfa deele shy

ci6n por su efectividad y por su baja toxicidad

8- ZCuales son las caracterrsticas que distinguen a la Sulfadiazina de

otras sulfonamidas

Las caracterrsticas que distinguen a la Sulfadiazina de las otras sulfona shy

midas son

a) Administrada por la via oral es bien tolerada por la rriucosa gastroinshy

testinal

b) Se absorbe la mayor parte por el intestino y muy poca se elimina por

las materias fecales

c) Tiene a-m-plic espectro antibacteriano ataca gdrmenes grampositivos

y gramnegativos

d) Tiene efectobacteriost~itico sobre los g6rmenes sensibles

e) Su actividad sobre los g~rmenes se manifiesta tanto local como en

forma general de ahique al pasar -por el intestino actda sobre los

g~rmenes pat6genos productoresdelas infecciones intestinales esshy

te es el efecti local Al absorbe-se a trav6s de la mucosa irtestishy

nal pasa la la circulaci6n y va a actuar sobre los g~rmenes localishy

zados en otros sitios del organismo ( ejem amigdalas ordos bronshy

quios pulmones) a esto es a lo que se llama acci6n general o acci6n

sist~mica

f) La Sulfadiazina se distribuye en todos los lrquidos y tejidos del orgashy

nismo pero tiene una caracterfstica que consiste en que pasa al liqui

exista o no inshyel 500 de la cantidad que hay en ia sangre

do cefalorraqufdeo

fecci6n de las meninges

se elimina por la via reshyse absorbi6 por cl int stino

g) La Sulf-dia z i n a que

han perdidoforna activa y acetilada ( los metabolitos acetilados

nal en

actividad antibacteriana)

por la admistraci6n de la Sulfadia h) Los trastornos secundarios producidos

el caso particular se man_ a todas las sulfas pero en

zina son comunes

anorexia n~useas v6mitos fiestan por trastorno3 digestivos tales como

el producse continue administrandolo que impide que

gastralgia etx

to

9 ZQu6 medicamento es el Q

silicato de aluminio hidratado que tiene propiedades protecto-El Caolrn es un

en forma de suspensi 6 n por la via oral for ras y absorbentes Administrado

las paredes del est6mago y del intestino quedando ma una capa protectorm a

Entre las propiedades que poseeintestinalprotegida la mucosa gstrica e

shy

el Caolrn podemos citar

gases y toxinasa) Absorbe Irquidos

mucosas secreshyb) Al proteger las paredes del tubo digestivo imnpide que las

el Caolfn ---En resumenpropiedad astringenteten lfquido de ahf su

a absorbentes (absorbe poseelas siguientes propiedades protectoras y shy

el lrquido del intestino shy

y toxinas) astringentes disminuyeagua gases

la materia fecal (antidiar-6ico)aquedando consistencia

posee la Pectina 10 Qud actividad medicamentosa

con un astringente el Cuando la Fectina se adrninistra por via oral asociada

scbre todo cuando el enfermo tie le forma cuerpo a la mnateria fecal

Caolin

ne aumentado el trCnsito intestinal de ahiq ue su uso principal sea en el trashy

tamiento de las diarreas tanto en los nifos como de los adultos ya sea una shy

diarrea simple o por infecci6n

11 61u6 propiedades tiene el Metilbrornuro de Pipenzolato

Aetilbromuro de -ipenzolato es un medicamento sint~tico anticolindrgico

cuyos efectos recuerdan las acciones perif~ricas de la atropina Produce -shy

-un efecto antisecretor gastrico asi como una disrninuci6n de la inotilidad

-intestinal Tiene un efecto antiespasm6dico sobre la fibra muscular lisa

del tracto biliar lIMetilbromuro de Pipenzolato quita el espasmo del

tracto gastrointestinal inferior asf como el del esfinter de Oddi y puede -shy

el sindrome del colon irritable -shyser Util en el tratamiento de la ileitis en

y en otros trastornos funcionales de los tractos gastrointestinal y biliar

12 ZCu6l es la acci6n farmacol6gica del producto ESTRESULFAN - N

es el resultado deLa acci6n farmacol6gica del producto ESTRESULFAN-N

la acci6n farmacodinrnica de cada uno de los principios activos que entran

a formar parte de la f6rmula El Sulfato de Estreptornicina antibi6tico de

que actdia sobre g6rrnenes gramnegativos principairnentepequefno espectro

con efecto bactericida sobre los microorganismos productores de las infecshy

ciones y de las diarreas La Sulfadiazina un quimiotergpico de acci6n

que ataca a los pat6genos productores de -shybacteriost~tica local y general

Estos dos antirnicrobianos son sindrgicos -shylas infeccio-es del intestino

lleva a cabo su acci6n bactericidaen su acci6n ya que la Estreptonnicina

sobr -o= g-rrn-Tn e - -t6genos porque interviene alterando la permeabilidad

de la rnembrana celular v el rnetabolisrno de las proteffnas en tanto que la

con el cido para-amin3benzoico en la formaci6n del -Sulfadiazina compite (l)

acido f6lico indispensable para la sobrevida de los ricroorganis-=s 51 Ileshy

tilboruro de Pipenzolato es un anticolinfrgico que disminuye las secreciones

del est6mago y la motilidad intestinal del tracto -igestivo quitandc los espasmos

en la fibra muscular lisa del intestino EI Caolin con sus propiedades protectoshy

la materiaras absorb~ntes v astringentes y la -ectina que le forma cuerpo a

fecal hacen al producto ESTRESULFAiN-N urna aziacion sinrgica para elshy

de los niilos o de los adultos (La formatratamiento de las dia-rreas infecciosas

lleva Caolfn ni Fectinafarmac4utica Capsulas no

13 LEn qu6 enfermedades esta indicado el producto ESTRESULFAN-N Capsu-shy

las y Suspensi6n

en ----El producto ESTRESULFAN-N Capsulas y Suspensi6n esta indicado

tratamiento de padecimientos del aparato digestivo en particular en las inshy

fecciones intestinalez que se acompafien de diarreas producidas por gdrmeshy

tales como Diarreas del nes sensibles a los antimicrobianos de la f6rmula

lactante de nifics o bi~n de los adultos producidas por Escherichia coli shy

etcSalmonellas Shigellas Staphylococcus aureus Streptococcus faecalis

14 ZC6mo se presenta al pdblico el producto ESTRESULFAN-N

El producto ESTRESULFANN-N se presenta al pdblico en dos formas farma-shy

con 30 mlc~utidas Capsulas y Suspensi6n Caja con 20 c 4psulas y Frasco

en forma de suspensi6n Una cucharadita de 5 ml de la suspensi6n tiene --

LCo i- 3- oulfai -zin y 75 de Sulfato de 7streptomicina

qu6 dosis se recornienda administra-r e] producto BSTRESULFAN-N15 zA

horas dependianto del pesoAdultos 2 a 4 cipsulas cada 4

peso por dra fraccionandcNinos 12 cucharadita de Suspensicn por kilo de

la dosis y administrindola cada 4 hcras

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

ESTRESULFAN-N C Psulas y Suspension

INSTRUCTIVO

ESTRESULFAN-N es el nombre de uno d e- pi ductos m~s conocidos de los

LABORATORIOS INFAN SA

1- E nombre de ESTRESU-FAN-N recuerdc algc de la f6rmula del producto

El nombre de ESTRESULFAN-N ( forma larmac~utica Cipsulas y Suspen-shy

si6n recuerda alguno de los comppnentes activos de la f6rmula En efecto

Estre se relaciona con el Sulfato de E treptomicina Sul a la Sulfadiashy

zina La terminaci6n Fan tambi~n alude al Labcratorio que lo fabrica

los Laboratorios lnfin SA y el calificativo N indica que es una nueva

f6rmula

2- 6Dentro de qu6 _rupo de productos debe colocarse el producto ESTRESULFAN-

N

El products ESTRESULFAN-N (ff capsulas y suspensi6n) debe agruparse shy

con los medicamentos antidiarr6icos

3- ZQud clase de medicamento es el producto ESTRESULFAN-N

El producto ESTRESULFAN-N es una especialidad farmac~utica indicada en

el tratamiento de las diarreas infecciosas

4- 4 Cuales son las f6rmulas integras del producto ESTRESULFAN-N Cipsulas

y Suspensi6n

ESTRESULFAN -N

C~osulas

FORMTLA Cada capsula conti-r=

Sulfato de estreptomicina equivalente a 75 Mrg

de estrept3micina base

-2shyrgSulfadiazina 200

Metilbromuro de-pipenza-lato 2 rag

Excipiente cbP i caipsula

FRESENTACION Caja con 20 capsulas

ESTRBESULFA N-N Suspensi6 r

FORMAULA Cada 100 Ml contienen

Sulfato de estreptomicina equivalente a 150 g

de estreptomicina base

Sulfadiazina 400 g

Netilbromuro de pipenzolato 25 mg

20C aolin

1 gPectina

100 MIlVehfculo cbp

PRESENTACION Frasco con 60 ml

5 - Cuil es el origen de la Estreptomicina uno de los principios activos shy

del producto ESTRESULFAN - N Cipsulas y Suspensi6n

se obtiene del cultivo de una actinomiceta el Strepto--La Estreptomicina

myces griseus que se encontr6 en el suelo Fue descubierta por Schatz

Bugie y Waksman en 1944 La producci6n industrial se produce partiendo

de cultivos sumergidos en tanques de fermentaci6n extray6ndose la estrep

con disolventes adecuados y sometitomicina previa filtraci6n y absorci6n

ti6 ndose al proceso de purificaci6np--robtener el producto puro pa-ra apli

caci6n en humanos

del Sulfato de Estreptomicina6- Cu6les son las caracterfsticas

Las caracterfsticas del Sulfato de Estreptomicina son las siguientes

--

-3shy

-a) Antibi6ticc de espectro reducido ataca fundamentalmente g~rmenes

Dentro de los gramnegashygramnegativos y uno que otro grampositivo

tivos tenernos Zscherichia coli Haeirop-iois influenzae o bacilo de --

Ffeiffer KIlebsiella pneumoniae o bacilo de Friedlander Fasteurella -

Neisseria gonorrhoeae Shigellaspoestis Basteurella tularensis

son-el Froteus mirabiplusmn1s y Pseudomona aeruginosamenos susceptibles

Sobre algunos grarnpositivos como Bacillus anthracis (catbunco)

Strptococcuspyogenes o Streptococos beta hemolrtico Tiene poco efec

to sobre Strptococcus viridans Streptococcus faecalis y Diplococcus shy

pneumonias o neumococo

De particular importancia es el efecto de la Estreptomicina sobre el

oMycobacterium tuberculosis bacilo de Koch

virus grandes ni pequefiosNo actda sobre espiroquetas Rickettsias

sensibles fundamentalmenb) Tiene efecto bactoricida sobre 103 g6rmenes

te cuando estain en el periodo de multiplicaci6n

por la via oral no se absorbe y toda la estreptomicina quec) Administrado

pone en contacto con los garmenesda en la luz del intestino en donde se

a quienes destruyepat6genos productores de las infecciones diarrdicas

las materias feshyd) La estreptomicina se elirnina por la vfa rectal junto con

cales

e) Como un factor que debe tomarse muy en cuenta en la actividad antimicro

es el pH del medio actuando con mayor potenbiana de la estreptomicina

cia en un medio alcalino y en menor actividad en un pH 6cido

acci6n hasta ahora aceptado se refiere af) El mezanismo de

10 - Alteraci6n de la permeabilidad de la membrana celular

lca dentro de la c~lula bacteriana lo que20 - Inhibiendo la sintesis prot

constituye el mecanisrno principal

-4shy

7 - jQu6 medicamento es la Sulfadiazina

La Sulfadiazina es el prototbipo de las sulfamidas Es un quimioterapico

de origen sintdtico es de las sulfonamida mis antiguas que ha resisshy

tido las prudbas a trav6s del tiempo y continua siendo la sulfa deele shy

ci6n por su efectividad y por su baja toxicidad

8- ZCuales son las caracterrsticas que distinguen a la Sulfadiazina de

otras sulfonamidas

Las caracterrsticas que distinguen a la Sulfadiazina de las otras sulfona shy

midas son

a) Administrada por la via oral es bien tolerada por la rriucosa gastroinshy

testinal

b) Se absorbe la mayor parte por el intestino y muy poca se elimina por

las materias fecales

c) Tiene a-m-plic espectro antibacteriano ataca gdrmenes grampositivos

y gramnegativos

d) Tiene efectobacteriost~itico sobre los g6rmenes sensibles

e) Su actividad sobre los g~rmenes se manifiesta tanto local como en

forma general de ahique al pasar -por el intestino actda sobre los

g~rmenes pat6genos productoresdelas infecciones intestinales esshy

te es el efecti local Al absorbe-se a trav6s de la mucosa irtestishy

nal pasa la la circulaci6n y va a actuar sobre los g~rmenes localishy

zados en otros sitios del organismo ( ejem amigdalas ordos bronshy

quios pulmones) a esto es a lo que se llama acci6n general o acci6n

sist~mica

f) La Sulfadiazina se distribuye en todos los lrquidos y tejidos del orgashy

nismo pero tiene una caracterfstica que consiste en que pasa al liqui

exista o no inshyel 500 de la cantidad que hay en ia sangre

do cefalorraqufdeo

fecci6n de las meninges

se elimina por la via reshyse absorbi6 por cl int stino

g) La Sulf-dia z i n a que

han perdidoforna activa y acetilada ( los metabolitos acetilados

nal en

actividad antibacteriana)

por la admistraci6n de la Sulfadia h) Los trastornos secundarios producidos

el caso particular se man_ a todas las sulfas pero en

zina son comunes

anorexia n~useas v6mitos fiestan por trastorno3 digestivos tales como

el producse continue administrandolo que impide que

gastralgia etx

to

9 ZQu6 medicamento es el Q

silicato de aluminio hidratado que tiene propiedades protecto-El Caolrn es un

en forma de suspensi 6 n por la via oral for ras y absorbentes Administrado

las paredes del est6mago y del intestino quedando ma una capa protectorm a

Entre las propiedades que poseeintestinalprotegida la mucosa gstrica e

shy

el Caolrn podemos citar

gases y toxinasa) Absorbe Irquidos

mucosas secreshyb) Al proteger las paredes del tubo digestivo imnpide que las

el Caolfn ---En resumenpropiedad astringenteten lfquido de ahf su

a absorbentes (absorbe poseelas siguientes propiedades protectoras y shy

el lrquido del intestino shy

y toxinas) astringentes disminuyeagua gases

la materia fecal (antidiar-6ico)aquedando consistencia

posee la Pectina 10 Qud actividad medicamentosa

con un astringente el Cuando la Fectina se adrninistra por via oral asociada

scbre todo cuando el enfermo tie le forma cuerpo a la mnateria fecal

Caolin

ne aumentado el trCnsito intestinal de ahiq ue su uso principal sea en el trashy

tamiento de las diarreas tanto en los nifos como de los adultos ya sea una shy

diarrea simple o por infecci6n

11 61u6 propiedades tiene el Metilbrornuro de Pipenzolato

Aetilbromuro de -ipenzolato es un medicamento sint~tico anticolindrgico

cuyos efectos recuerdan las acciones perif~ricas de la atropina Produce -shy

-un efecto antisecretor gastrico asi como una disrninuci6n de la inotilidad

-intestinal Tiene un efecto antiespasm6dico sobre la fibra muscular lisa

del tracto biliar lIMetilbromuro de Pipenzolato quita el espasmo del

tracto gastrointestinal inferior asf como el del esfinter de Oddi y puede -shy

el sindrome del colon irritable -shyser Util en el tratamiento de la ileitis en

y en otros trastornos funcionales de los tractos gastrointestinal y biliar

12 ZCu6l es la acci6n farmacol6gica del producto ESTRESULFAN - N

es el resultado deLa acci6n farmacol6gica del producto ESTRESULFAN-N

la acci6n farmacodinrnica de cada uno de los principios activos que entran

a formar parte de la f6rmula El Sulfato de Estreptornicina antibi6tico de

que actdia sobre g6rrnenes gramnegativos principairnentepequefno espectro

con efecto bactericida sobre los microorganismos productores de las infecshy

ciones y de las diarreas La Sulfadiazina un quimiotergpico de acci6n

que ataca a los pat6genos productores de -shybacteriost~tica local y general

Estos dos antirnicrobianos son sindrgicos -shylas infeccio-es del intestino

lleva a cabo su acci6n bactericidaen su acci6n ya que la Estreptonnicina

sobr -o= g-rrn-Tn e - -t6genos porque interviene alterando la permeabilidad

de la rnembrana celular v el rnetabolisrno de las proteffnas en tanto que la

con el cido para-amin3benzoico en la formaci6n del -Sulfadiazina compite (l)

acido f6lico indispensable para la sobrevida de los ricroorganis-=s 51 Ileshy

tilboruro de Pipenzolato es un anticolinfrgico que disminuye las secreciones

del est6mago y la motilidad intestinal del tracto -igestivo quitandc los espasmos

en la fibra muscular lisa del intestino EI Caolin con sus propiedades protectoshy

la materiaras absorb~ntes v astringentes y la -ectina que le forma cuerpo a

fecal hacen al producto ESTRESULFAiN-N urna aziacion sinrgica para elshy

de los niilos o de los adultos (La formatratamiento de las dia-rreas infecciosas

lleva Caolfn ni Fectinafarmac4utica Capsulas no

13 LEn qu6 enfermedades esta indicado el producto ESTRESULFAN-N Capsu-shy

las y Suspensi6n

en ----El producto ESTRESULFAN-N Capsulas y Suspensi6n esta indicado

tratamiento de padecimientos del aparato digestivo en particular en las inshy

fecciones intestinalez que se acompafien de diarreas producidas por gdrmeshy

tales como Diarreas del nes sensibles a los antimicrobianos de la f6rmula

lactante de nifics o bi~n de los adultos producidas por Escherichia coli shy

etcSalmonellas Shigellas Staphylococcus aureus Streptococcus faecalis

14 ZC6mo se presenta al pdblico el producto ESTRESULFAN-N

El producto ESTRESULFANN-N se presenta al pdblico en dos formas farma-shy

con 30 mlc~utidas Capsulas y Suspensi6n Caja con 20 c 4psulas y Frasco

en forma de suspensi6n Una cucharadita de 5 ml de la suspensi6n tiene --

LCo i- 3- oulfai -zin y 75 de Sulfato de 7streptomicina

qu6 dosis se recornienda administra-r e] producto BSTRESULFAN-N15 zA

horas dependianto del pesoAdultos 2 a 4 cipsulas cada 4

peso por dra fraccionandcNinos 12 cucharadita de Suspensicn por kilo de

la dosis y administrindola cada 4 hcras

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

-2shyrgSulfadiazina 200

Metilbromuro de-pipenza-lato 2 rag

Excipiente cbP i caipsula

FRESENTACION Caja con 20 capsulas

ESTRBESULFA N-N Suspensi6 r

FORMAULA Cada 100 Ml contienen

Sulfato de estreptomicina equivalente a 150 g

de estreptomicina base

Sulfadiazina 400 g

Netilbromuro de pipenzolato 25 mg

20C aolin

1 gPectina

100 MIlVehfculo cbp

PRESENTACION Frasco con 60 ml

5 - Cuil es el origen de la Estreptomicina uno de los principios activos shy

del producto ESTRESULFAN - N Cipsulas y Suspensi6n

se obtiene del cultivo de una actinomiceta el Strepto--La Estreptomicina

myces griseus que se encontr6 en el suelo Fue descubierta por Schatz

Bugie y Waksman en 1944 La producci6n industrial se produce partiendo

de cultivos sumergidos en tanques de fermentaci6n extray6ndose la estrep

con disolventes adecuados y sometitomicina previa filtraci6n y absorci6n

ti6 ndose al proceso de purificaci6np--robtener el producto puro pa-ra apli

caci6n en humanos

del Sulfato de Estreptomicina6- Cu6les son las caracterfsticas

Las caracterfsticas del Sulfato de Estreptomicina son las siguientes

--

-3shy

-a) Antibi6ticc de espectro reducido ataca fundamentalmente g~rmenes

Dentro de los gramnegashygramnegativos y uno que otro grampositivo

tivos tenernos Zscherichia coli Haeirop-iois influenzae o bacilo de --

Ffeiffer KIlebsiella pneumoniae o bacilo de Friedlander Fasteurella -

Neisseria gonorrhoeae Shigellaspoestis Basteurella tularensis

son-el Froteus mirabiplusmn1s y Pseudomona aeruginosamenos susceptibles

Sobre algunos grarnpositivos como Bacillus anthracis (catbunco)

Strptococcuspyogenes o Streptococos beta hemolrtico Tiene poco efec

to sobre Strptococcus viridans Streptococcus faecalis y Diplococcus shy

pneumonias o neumococo

De particular importancia es el efecto de la Estreptomicina sobre el

oMycobacterium tuberculosis bacilo de Koch

virus grandes ni pequefiosNo actda sobre espiroquetas Rickettsias

sensibles fundamentalmenb) Tiene efecto bactoricida sobre 103 g6rmenes

te cuando estain en el periodo de multiplicaci6n

por la via oral no se absorbe y toda la estreptomicina quec) Administrado

pone en contacto con los garmenesda en la luz del intestino en donde se

a quienes destruyepat6genos productores de las infecciones diarrdicas

las materias feshyd) La estreptomicina se elirnina por la vfa rectal junto con

cales

e) Como un factor que debe tomarse muy en cuenta en la actividad antimicro

es el pH del medio actuando con mayor potenbiana de la estreptomicina

cia en un medio alcalino y en menor actividad en un pH 6cido

acci6n hasta ahora aceptado se refiere af) El mezanismo de

10 - Alteraci6n de la permeabilidad de la membrana celular

lca dentro de la c~lula bacteriana lo que20 - Inhibiendo la sintesis prot

constituye el mecanisrno principal

-4shy

7 - jQu6 medicamento es la Sulfadiazina

La Sulfadiazina es el prototbipo de las sulfamidas Es un quimioterapico

de origen sintdtico es de las sulfonamida mis antiguas que ha resisshy

tido las prudbas a trav6s del tiempo y continua siendo la sulfa deele shy

ci6n por su efectividad y por su baja toxicidad

8- ZCuales son las caracterrsticas que distinguen a la Sulfadiazina de

otras sulfonamidas

Las caracterrsticas que distinguen a la Sulfadiazina de las otras sulfona shy

midas son

a) Administrada por la via oral es bien tolerada por la rriucosa gastroinshy

testinal

b) Se absorbe la mayor parte por el intestino y muy poca se elimina por

las materias fecales

c) Tiene a-m-plic espectro antibacteriano ataca gdrmenes grampositivos

y gramnegativos

d) Tiene efectobacteriost~itico sobre los g6rmenes sensibles

e) Su actividad sobre los g~rmenes se manifiesta tanto local como en

forma general de ahique al pasar -por el intestino actda sobre los

g~rmenes pat6genos productoresdelas infecciones intestinales esshy

te es el efecti local Al absorbe-se a trav6s de la mucosa irtestishy

nal pasa la la circulaci6n y va a actuar sobre los g~rmenes localishy

zados en otros sitios del organismo ( ejem amigdalas ordos bronshy

quios pulmones) a esto es a lo que se llama acci6n general o acci6n

sist~mica

f) La Sulfadiazina se distribuye en todos los lrquidos y tejidos del orgashy

nismo pero tiene una caracterfstica que consiste en que pasa al liqui

exista o no inshyel 500 de la cantidad que hay en ia sangre

do cefalorraqufdeo

fecci6n de las meninges

se elimina por la via reshyse absorbi6 por cl int stino

g) La Sulf-dia z i n a que

han perdidoforna activa y acetilada ( los metabolitos acetilados

nal en

actividad antibacteriana)

por la admistraci6n de la Sulfadia h) Los trastornos secundarios producidos

el caso particular se man_ a todas las sulfas pero en

zina son comunes

anorexia n~useas v6mitos fiestan por trastorno3 digestivos tales como

el producse continue administrandolo que impide que

gastralgia etx

to

9 ZQu6 medicamento es el Q

silicato de aluminio hidratado que tiene propiedades protecto-El Caolrn es un

en forma de suspensi 6 n por la via oral for ras y absorbentes Administrado

las paredes del est6mago y del intestino quedando ma una capa protectorm a

Entre las propiedades que poseeintestinalprotegida la mucosa gstrica e

shy

el Caolrn podemos citar

gases y toxinasa) Absorbe Irquidos

mucosas secreshyb) Al proteger las paredes del tubo digestivo imnpide que las

el Caolfn ---En resumenpropiedad astringenteten lfquido de ahf su

a absorbentes (absorbe poseelas siguientes propiedades protectoras y shy

el lrquido del intestino shy

y toxinas) astringentes disminuyeagua gases

la materia fecal (antidiar-6ico)aquedando consistencia

posee la Pectina 10 Qud actividad medicamentosa

con un astringente el Cuando la Fectina se adrninistra por via oral asociada

scbre todo cuando el enfermo tie le forma cuerpo a la mnateria fecal

Caolin

ne aumentado el trCnsito intestinal de ahiq ue su uso principal sea en el trashy

tamiento de las diarreas tanto en los nifos como de los adultos ya sea una shy

diarrea simple o por infecci6n

11 61u6 propiedades tiene el Metilbrornuro de Pipenzolato

Aetilbromuro de -ipenzolato es un medicamento sint~tico anticolindrgico

cuyos efectos recuerdan las acciones perif~ricas de la atropina Produce -shy

-un efecto antisecretor gastrico asi como una disrninuci6n de la inotilidad

-intestinal Tiene un efecto antiespasm6dico sobre la fibra muscular lisa

del tracto biliar lIMetilbromuro de Pipenzolato quita el espasmo del

tracto gastrointestinal inferior asf como el del esfinter de Oddi y puede -shy

el sindrome del colon irritable -shyser Util en el tratamiento de la ileitis en

y en otros trastornos funcionales de los tractos gastrointestinal y biliar

12 ZCu6l es la acci6n farmacol6gica del producto ESTRESULFAN - N

es el resultado deLa acci6n farmacol6gica del producto ESTRESULFAN-N

la acci6n farmacodinrnica de cada uno de los principios activos que entran

a formar parte de la f6rmula El Sulfato de Estreptornicina antibi6tico de

que actdia sobre g6rrnenes gramnegativos principairnentepequefno espectro

con efecto bactericida sobre los microorganismos productores de las infecshy

ciones y de las diarreas La Sulfadiazina un quimiotergpico de acci6n

que ataca a los pat6genos productores de -shybacteriost~tica local y general

Estos dos antirnicrobianos son sindrgicos -shylas infeccio-es del intestino

lleva a cabo su acci6n bactericidaen su acci6n ya que la Estreptonnicina

sobr -o= g-rrn-Tn e - -t6genos porque interviene alterando la permeabilidad

de la rnembrana celular v el rnetabolisrno de las proteffnas en tanto que la

con el cido para-amin3benzoico en la formaci6n del -Sulfadiazina compite (l)

acido f6lico indispensable para la sobrevida de los ricroorganis-=s 51 Ileshy

tilboruro de Pipenzolato es un anticolinfrgico que disminuye las secreciones

del est6mago y la motilidad intestinal del tracto -igestivo quitandc los espasmos

en la fibra muscular lisa del intestino EI Caolin con sus propiedades protectoshy

la materiaras absorb~ntes v astringentes y la -ectina que le forma cuerpo a

fecal hacen al producto ESTRESULFAiN-N urna aziacion sinrgica para elshy

de los niilos o de los adultos (La formatratamiento de las dia-rreas infecciosas

lleva Caolfn ni Fectinafarmac4utica Capsulas no

13 LEn qu6 enfermedades esta indicado el producto ESTRESULFAN-N Capsu-shy

las y Suspensi6n

en ----El producto ESTRESULFAN-N Capsulas y Suspensi6n esta indicado

tratamiento de padecimientos del aparato digestivo en particular en las inshy

fecciones intestinalez que se acompafien de diarreas producidas por gdrmeshy

tales como Diarreas del nes sensibles a los antimicrobianos de la f6rmula

lactante de nifics o bi~n de los adultos producidas por Escherichia coli shy

etcSalmonellas Shigellas Staphylococcus aureus Streptococcus faecalis

14 ZC6mo se presenta al pdblico el producto ESTRESULFAN-N

El producto ESTRESULFANN-N se presenta al pdblico en dos formas farma-shy

con 30 mlc~utidas Capsulas y Suspensi6n Caja con 20 c 4psulas y Frasco

en forma de suspensi6n Una cucharadita de 5 ml de la suspensi6n tiene --

LCo i- 3- oulfai -zin y 75 de Sulfato de 7streptomicina

qu6 dosis se recornienda administra-r e] producto BSTRESULFAN-N15 zA

horas dependianto del pesoAdultos 2 a 4 cipsulas cada 4

peso por dra fraccionandcNinos 12 cucharadita de Suspensicn por kilo de

la dosis y administrindola cada 4 hcras

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

--

-3shy

-a) Antibi6ticc de espectro reducido ataca fundamentalmente g~rmenes

Dentro de los gramnegashygramnegativos y uno que otro grampositivo

tivos tenernos Zscherichia coli Haeirop-iois influenzae o bacilo de --

Ffeiffer KIlebsiella pneumoniae o bacilo de Friedlander Fasteurella -

Neisseria gonorrhoeae Shigellaspoestis Basteurella tularensis

son-el Froteus mirabiplusmn1s y Pseudomona aeruginosamenos susceptibles

Sobre algunos grarnpositivos como Bacillus anthracis (catbunco)

Strptococcuspyogenes o Streptococos beta hemolrtico Tiene poco efec

to sobre Strptococcus viridans Streptococcus faecalis y Diplococcus shy

pneumonias o neumococo

De particular importancia es el efecto de la Estreptomicina sobre el

oMycobacterium tuberculosis bacilo de Koch

virus grandes ni pequefiosNo actda sobre espiroquetas Rickettsias

sensibles fundamentalmenb) Tiene efecto bactoricida sobre 103 g6rmenes

te cuando estain en el periodo de multiplicaci6n

por la via oral no se absorbe y toda la estreptomicina quec) Administrado

pone en contacto con los garmenesda en la luz del intestino en donde se

a quienes destruyepat6genos productores de las infecciones diarrdicas

las materias feshyd) La estreptomicina se elirnina por la vfa rectal junto con

cales

e) Como un factor que debe tomarse muy en cuenta en la actividad antimicro

es el pH del medio actuando con mayor potenbiana de la estreptomicina

cia en un medio alcalino y en menor actividad en un pH 6cido

acci6n hasta ahora aceptado se refiere af) El mezanismo de

10 - Alteraci6n de la permeabilidad de la membrana celular

lca dentro de la c~lula bacteriana lo que20 - Inhibiendo la sintesis prot

constituye el mecanisrno principal

-4shy

7 - jQu6 medicamento es la Sulfadiazina

La Sulfadiazina es el prototbipo de las sulfamidas Es un quimioterapico

de origen sintdtico es de las sulfonamida mis antiguas que ha resisshy

tido las prudbas a trav6s del tiempo y continua siendo la sulfa deele shy

ci6n por su efectividad y por su baja toxicidad

8- ZCuales son las caracterrsticas que distinguen a la Sulfadiazina de

otras sulfonamidas

Las caracterrsticas que distinguen a la Sulfadiazina de las otras sulfona shy

midas son

a) Administrada por la via oral es bien tolerada por la rriucosa gastroinshy

testinal

b) Se absorbe la mayor parte por el intestino y muy poca se elimina por

las materias fecales

c) Tiene a-m-plic espectro antibacteriano ataca gdrmenes grampositivos

y gramnegativos

d) Tiene efectobacteriost~itico sobre los g6rmenes sensibles

e) Su actividad sobre los g~rmenes se manifiesta tanto local como en

forma general de ahique al pasar -por el intestino actda sobre los

g~rmenes pat6genos productoresdelas infecciones intestinales esshy

te es el efecti local Al absorbe-se a trav6s de la mucosa irtestishy

nal pasa la la circulaci6n y va a actuar sobre los g~rmenes localishy

zados en otros sitios del organismo ( ejem amigdalas ordos bronshy

quios pulmones) a esto es a lo que se llama acci6n general o acci6n

sist~mica

f) La Sulfadiazina se distribuye en todos los lrquidos y tejidos del orgashy

nismo pero tiene una caracterfstica que consiste en que pasa al liqui

exista o no inshyel 500 de la cantidad que hay en ia sangre

do cefalorraqufdeo

fecci6n de las meninges

se elimina por la via reshyse absorbi6 por cl int stino

g) La Sulf-dia z i n a que

han perdidoforna activa y acetilada ( los metabolitos acetilados

nal en

actividad antibacteriana)

por la admistraci6n de la Sulfadia h) Los trastornos secundarios producidos

el caso particular se man_ a todas las sulfas pero en

zina son comunes

anorexia n~useas v6mitos fiestan por trastorno3 digestivos tales como

el producse continue administrandolo que impide que

gastralgia etx

to

9 ZQu6 medicamento es el Q

silicato de aluminio hidratado que tiene propiedades protecto-El Caolrn es un

en forma de suspensi 6 n por la via oral for ras y absorbentes Administrado

las paredes del est6mago y del intestino quedando ma una capa protectorm a

Entre las propiedades que poseeintestinalprotegida la mucosa gstrica e

shy

el Caolrn podemos citar

gases y toxinasa) Absorbe Irquidos

mucosas secreshyb) Al proteger las paredes del tubo digestivo imnpide que las

el Caolfn ---En resumenpropiedad astringenteten lfquido de ahf su

a absorbentes (absorbe poseelas siguientes propiedades protectoras y shy

el lrquido del intestino shy

y toxinas) astringentes disminuyeagua gases

la materia fecal (antidiar-6ico)aquedando consistencia

posee la Pectina 10 Qud actividad medicamentosa

con un astringente el Cuando la Fectina se adrninistra por via oral asociada

scbre todo cuando el enfermo tie le forma cuerpo a la mnateria fecal

Caolin

ne aumentado el trCnsito intestinal de ahiq ue su uso principal sea en el trashy

tamiento de las diarreas tanto en los nifos como de los adultos ya sea una shy

diarrea simple o por infecci6n

11 61u6 propiedades tiene el Metilbrornuro de Pipenzolato

Aetilbromuro de -ipenzolato es un medicamento sint~tico anticolindrgico

cuyos efectos recuerdan las acciones perif~ricas de la atropina Produce -shy

-un efecto antisecretor gastrico asi como una disrninuci6n de la inotilidad

-intestinal Tiene un efecto antiespasm6dico sobre la fibra muscular lisa

del tracto biliar lIMetilbromuro de Pipenzolato quita el espasmo del

tracto gastrointestinal inferior asf como el del esfinter de Oddi y puede -shy

el sindrome del colon irritable -shyser Util en el tratamiento de la ileitis en

y en otros trastornos funcionales de los tractos gastrointestinal y biliar

12 ZCu6l es la acci6n farmacol6gica del producto ESTRESULFAN - N

es el resultado deLa acci6n farmacol6gica del producto ESTRESULFAN-N

la acci6n farmacodinrnica de cada uno de los principios activos que entran

a formar parte de la f6rmula El Sulfato de Estreptornicina antibi6tico de

que actdia sobre g6rrnenes gramnegativos principairnentepequefno espectro

con efecto bactericida sobre los microorganismos productores de las infecshy

ciones y de las diarreas La Sulfadiazina un quimiotergpico de acci6n

que ataca a los pat6genos productores de -shybacteriost~tica local y general

Estos dos antirnicrobianos son sindrgicos -shylas infeccio-es del intestino

lleva a cabo su acci6n bactericidaen su acci6n ya que la Estreptonnicina

sobr -o= g-rrn-Tn e - -t6genos porque interviene alterando la permeabilidad

de la rnembrana celular v el rnetabolisrno de las proteffnas en tanto que la

con el cido para-amin3benzoico en la formaci6n del -Sulfadiazina compite (l)

acido f6lico indispensable para la sobrevida de los ricroorganis-=s 51 Ileshy

tilboruro de Pipenzolato es un anticolinfrgico que disminuye las secreciones

del est6mago y la motilidad intestinal del tracto -igestivo quitandc los espasmos

en la fibra muscular lisa del intestino EI Caolin con sus propiedades protectoshy

la materiaras absorb~ntes v astringentes y la -ectina que le forma cuerpo a

fecal hacen al producto ESTRESULFAiN-N urna aziacion sinrgica para elshy

de los niilos o de los adultos (La formatratamiento de las dia-rreas infecciosas

lleva Caolfn ni Fectinafarmac4utica Capsulas no

13 LEn qu6 enfermedades esta indicado el producto ESTRESULFAN-N Capsu-shy

las y Suspensi6n

en ----El producto ESTRESULFAN-N Capsulas y Suspensi6n esta indicado

tratamiento de padecimientos del aparato digestivo en particular en las inshy

fecciones intestinalez que se acompafien de diarreas producidas por gdrmeshy

tales como Diarreas del nes sensibles a los antimicrobianos de la f6rmula

lactante de nifics o bi~n de los adultos producidas por Escherichia coli shy

etcSalmonellas Shigellas Staphylococcus aureus Streptococcus faecalis

14 ZC6mo se presenta al pdblico el producto ESTRESULFAN-N

El producto ESTRESULFANN-N se presenta al pdblico en dos formas farma-shy

con 30 mlc~utidas Capsulas y Suspensi6n Caja con 20 c 4psulas y Frasco

en forma de suspensi6n Una cucharadita de 5 ml de la suspensi6n tiene --

LCo i- 3- oulfai -zin y 75 de Sulfato de 7streptomicina

qu6 dosis se recornienda administra-r e] producto BSTRESULFAN-N15 zA

horas dependianto del pesoAdultos 2 a 4 cipsulas cada 4

peso por dra fraccionandcNinos 12 cucharadita de Suspensicn por kilo de

la dosis y administrindola cada 4 hcras

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

-4shy

7 - jQu6 medicamento es la Sulfadiazina

La Sulfadiazina es el prototbipo de las sulfamidas Es un quimioterapico

de origen sintdtico es de las sulfonamida mis antiguas que ha resisshy

tido las prudbas a trav6s del tiempo y continua siendo la sulfa deele shy

ci6n por su efectividad y por su baja toxicidad

8- ZCuales son las caracterrsticas que distinguen a la Sulfadiazina de

otras sulfonamidas

Las caracterrsticas que distinguen a la Sulfadiazina de las otras sulfona shy

midas son

a) Administrada por la via oral es bien tolerada por la rriucosa gastroinshy

testinal

b) Se absorbe la mayor parte por el intestino y muy poca se elimina por

las materias fecales

c) Tiene a-m-plic espectro antibacteriano ataca gdrmenes grampositivos

y gramnegativos

d) Tiene efectobacteriost~itico sobre los g6rmenes sensibles

e) Su actividad sobre los g~rmenes se manifiesta tanto local como en

forma general de ahique al pasar -por el intestino actda sobre los

g~rmenes pat6genos productoresdelas infecciones intestinales esshy

te es el efecti local Al absorbe-se a trav6s de la mucosa irtestishy

nal pasa la la circulaci6n y va a actuar sobre los g~rmenes localishy

zados en otros sitios del organismo ( ejem amigdalas ordos bronshy

quios pulmones) a esto es a lo que se llama acci6n general o acci6n

sist~mica

f) La Sulfadiazina se distribuye en todos los lrquidos y tejidos del orgashy

nismo pero tiene una caracterfstica que consiste en que pasa al liqui

exista o no inshyel 500 de la cantidad que hay en ia sangre

do cefalorraqufdeo

fecci6n de las meninges

se elimina por la via reshyse absorbi6 por cl int stino

g) La Sulf-dia z i n a que

han perdidoforna activa y acetilada ( los metabolitos acetilados

nal en

actividad antibacteriana)

por la admistraci6n de la Sulfadia h) Los trastornos secundarios producidos

el caso particular se man_ a todas las sulfas pero en

zina son comunes

anorexia n~useas v6mitos fiestan por trastorno3 digestivos tales como

el producse continue administrandolo que impide que

gastralgia etx

to

9 ZQu6 medicamento es el Q

silicato de aluminio hidratado que tiene propiedades protecto-El Caolrn es un

en forma de suspensi 6 n por la via oral for ras y absorbentes Administrado

las paredes del est6mago y del intestino quedando ma una capa protectorm a

Entre las propiedades que poseeintestinalprotegida la mucosa gstrica e

shy

el Caolrn podemos citar

gases y toxinasa) Absorbe Irquidos

mucosas secreshyb) Al proteger las paredes del tubo digestivo imnpide que las

el Caolfn ---En resumenpropiedad astringenteten lfquido de ahf su

a absorbentes (absorbe poseelas siguientes propiedades protectoras y shy

el lrquido del intestino shy

y toxinas) astringentes disminuyeagua gases

la materia fecal (antidiar-6ico)aquedando consistencia

posee la Pectina 10 Qud actividad medicamentosa

con un astringente el Cuando la Fectina se adrninistra por via oral asociada

scbre todo cuando el enfermo tie le forma cuerpo a la mnateria fecal

Caolin

ne aumentado el trCnsito intestinal de ahiq ue su uso principal sea en el trashy

tamiento de las diarreas tanto en los nifos como de los adultos ya sea una shy

diarrea simple o por infecci6n

11 61u6 propiedades tiene el Metilbrornuro de Pipenzolato

Aetilbromuro de -ipenzolato es un medicamento sint~tico anticolindrgico

cuyos efectos recuerdan las acciones perif~ricas de la atropina Produce -shy

-un efecto antisecretor gastrico asi como una disrninuci6n de la inotilidad

-intestinal Tiene un efecto antiespasm6dico sobre la fibra muscular lisa

del tracto biliar lIMetilbromuro de Pipenzolato quita el espasmo del

tracto gastrointestinal inferior asf como el del esfinter de Oddi y puede -shy

el sindrome del colon irritable -shyser Util en el tratamiento de la ileitis en

y en otros trastornos funcionales de los tractos gastrointestinal y biliar

12 ZCu6l es la acci6n farmacol6gica del producto ESTRESULFAN - N

es el resultado deLa acci6n farmacol6gica del producto ESTRESULFAN-N

la acci6n farmacodinrnica de cada uno de los principios activos que entran

a formar parte de la f6rmula El Sulfato de Estreptornicina antibi6tico de

que actdia sobre g6rrnenes gramnegativos principairnentepequefno espectro

con efecto bactericida sobre los microorganismos productores de las infecshy

ciones y de las diarreas La Sulfadiazina un quimiotergpico de acci6n

que ataca a los pat6genos productores de -shybacteriost~tica local y general

Estos dos antirnicrobianos son sindrgicos -shylas infeccio-es del intestino

lleva a cabo su acci6n bactericidaen su acci6n ya que la Estreptonnicina

sobr -o= g-rrn-Tn e - -t6genos porque interviene alterando la permeabilidad

de la rnembrana celular v el rnetabolisrno de las proteffnas en tanto que la

con el cido para-amin3benzoico en la formaci6n del -Sulfadiazina compite (l)

acido f6lico indispensable para la sobrevida de los ricroorganis-=s 51 Ileshy

tilboruro de Pipenzolato es un anticolinfrgico que disminuye las secreciones

del est6mago y la motilidad intestinal del tracto -igestivo quitandc los espasmos

en la fibra muscular lisa del intestino EI Caolin con sus propiedades protectoshy

la materiaras absorb~ntes v astringentes y la -ectina que le forma cuerpo a

fecal hacen al producto ESTRESULFAiN-N urna aziacion sinrgica para elshy

de los niilos o de los adultos (La formatratamiento de las dia-rreas infecciosas

lleva Caolfn ni Fectinafarmac4utica Capsulas no

13 LEn qu6 enfermedades esta indicado el producto ESTRESULFAN-N Capsu-shy

las y Suspensi6n

en ----El producto ESTRESULFAN-N Capsulas y Suspensi6n esta indicado

tratamiento de padecimientos del aparato digestivo en particular en las inshy

fecciones intestinalez que se acompafien de diarreas producidas por gdrmeshy

tales como Diarreas del nes sensibles a los antimicrobianos de la f6rmula

lactante de nifics o bi~n de los adultos producidas por Escherichia coli shy

etcSalmonellas Shigellas Staphylococcus aureus Streptococcus faecalis

14 ZC6mo se presenta al pdblico el producto ESTRESULFAN-N

El producto ESTRESULFANN-N se presenta al pdblico en dos formas farma-shy

con 30 mlc~utidas Capsulas y Suspensi6n Caja con 20 c 4psulas y Frasco

en forma de suspensi6n Una cucharadita de 5 ml de la suspensi6n tiene --

LCo i- 3- oulfai -zin y 75 de Sulfato de 7streptomicina

qu6 dosis se recornienda administra-r e] producto BSTRESULFAN-N15 zA

horas dependianto del pesoAdultos 2 a 4 cipsulas cada 4

peso por dra fraccionandcNinos 12 cucharadita de Suspensicn por kilo de

la dosis y administrindola cada 4 hcras

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

exista o no inshyel 500 de la cantidad que hay en ia sangre

do cefalorraqufdeo

fecci6n de las meninges

se elimina por la via reshyse absorbi6 por cl int stino

g) La Sulf-dia z i n a que

han perdidoforna activa y acetilada ( los metabolitos acetilados

nal en

actividad antibacteriana)

por la admistraci6n de la Sulfadia h) Los trastornos secundarios producidos

el caso particular se man_ a todas las sulfas pero en

zina son comunes

anorexia n~useas v6mitos fiestan por trastorno3 digestivos tales como

el producse continue administrandolo que impide que

gastralgia etx

to

9 ZQu6 medicamento es el Q

silicato de aluminio hidratado que tiene propiedades protecto-El Caolrn es un

en forma de suspensi 6 n por la via oral for ras y absorbentes Administrado

las paredes del est6mago y del intestino quedando ma una capa protectorm a

Entre las propiedades que poseeintestinalprotegida la mucosa gstrica e

shy

el Caolrn podemos citar

gases y toxinasa) Absorbe Irquidos

mucosas secreshyb) Al proteger las paredes del tubo digestivo imnpide que las

el Caolfn ---En resumenpropiedad astringenteten lfquido de ahf su

a absorbentes (absorbe poseelas siguientes propiedades protectoras y shy

el lrquido del intestino shy

y toxinas) astringentes disminuyeagua gases

la materia fecal (antidiar-6ico)aquedando consistencia

posee la Pectina 10 Qud actividad medicamentosa

con un astringente el Cuando la Fectina se adrninistra por via oral asociada

scbre todo cuando el enfermo tie le forma cuerpo a la mnateria fecal

Caolin

ne aumentado el trCnsito intestinal de ahiq ue su uso principal sea en el trashy

tamiento de las diarreas tanto en los nifos como de los adultos ya sea una shy

diarrea simple o por infecci6n

11 61u6 propiedades tiene el Metilbrornuro de Pipenzolato

Aetilbromuro de -ipenzolato es un medicamento sint~tico anticolindrgico

cuyos efectos recuerdan las acciones perif~ricas de la atropina Produce -shy

-un efecto antisecretor gastrico asi como una disrninuci6n de la inotilidad

-intestinal Tiene un efecto antiespasm6dico sobre la fibra muscular lisa

del tracto biliar lIMetilbromuro de Pipenzolato quita el espasmo del

tracto gastrointestinal inferior asf como el del esfinter de Oddi y puede -shy

el sindrome del colon irritable -shyser Util en el tratamiento de la ileitis en

y en otros trastornos funcionales de los tractos gastrointestinal y biliar

12 ZCu6l es la acci6n farmacol6gica del producto ESTRESULFAN - N

es el resultado deLa acci6n farmacol6gica del producto ESTRESULFAN-N

la acci6n farmacodinrnica de cada uno de los principios activos que entran

a formar parte de la f6rmula El Sulfato de Estreptornicina antibi6tico de

que actdia sobre g6rrnenes gramnegativos principairnentepequefno espectro

con efecto bactericida sobre los microorganismos productores de las infecshy

ciones y de las diarreas La Sulfadiazina un quimiotergpico de acci6n

que ataca a los pat6genos productores de -shybacteriost~tica local y general

Estos dos antirnicrobianos son sindrgicos -shylas infeccio-es del intestino

lleva a cabo su acci6n bactericidaen su acci6n ya que la Estreptonnicina

sobr -o= g-rrn-Tn e - -t6genos porque interviene alterando la permeabilidad

de la rnembrana celular v el rnetabolisrno de las proteffnas en tanto que la

con el cido para-amin3benzoico en la formaci6n del -Sulfadiazina compite (l)

acido f6lico indispensable para la sobrevida de los ricroorganis-=s 51 Ileshy

tilboruro de Pipenzolato es un anticolinfrgico que disminuye las secreciones

del est6mago y la motilidad intestinal del tracto -igestivo quitandc los espasmos

en la fibra muscular lisa del intestino EI Caolin con sus propiedades protectoshy

la materiaras absorb~ntes v astringentes y la -ectina que le forma cuerpo a

fecal hacen al producto ESTRESULFAiN-N urna aziacion sinrgica para elshy

de los niilos o de los adultos (La formatratamiento de las dia-rreas infecciosas

lleva Caolfn ni Fectinafarmac4utica Capsulas no

13 LEn qu6 enfermedades esta indicado el producto ESTRESULFAN-N Capsu-shy

las y Suspensi6n

en ----El producto ESTRESULFAN-N Capsulas y Suspensi6n esta indicado

tratamiento de padecimientos del aparato digestivo en particular en las inshy

fecciones intestinalez que se acompafien de diarreas producidas por gdrmeshy

tales como Diarreas del nes sensibles a los antimicrobianos de la f6rmula

lactante de nifics o bi~n de los adultos producidas por Escherichia coli shy

etcSalmonellas Shigellas Staphylococcus aureus Streptococcus faecalis

14 ZC6mo se presenta al pdblico el producto ESTRESULFAN-N

El producto ESTRESULFANN-N se presenta al pdblico en dos formas farma-shy

con 30 mlc~utidas Capsulas y Suspensi6n Caja con 20 c 4psulas y Frasco

en forma de suspensi6n Una cucharadita de 5 ml de la suspensi6n tiene --

LCo i- 3- oulfai -zin y 75 de Sulfato de 7streptomicina

qu6 dosis se recornienda administra-r e] producto BSTRESULFAN-N15 zA

horas dependianto del pesoAdultos 2 a 4 cipsulas cada 4

peso por dra fraccionandcNinos 12 cucharadita de Suspensicn por kilo de

la dosis y administrindola cada 4 hcras

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

ne aumentado el trCnsito intestinal de ahiq ue su uso principal sea en el trashy

tamiento de las diarreas tanto en los nifos como de los adultos ya sea una shy

diarrea simple o por infecci6n

11 61u6 propiedades tiene el Metilbrornuro de Pipenzolato

Aetilbromuro de -ipenzolato es un medicamento sint~tico anticolindrgico

cuyos efectos recuerdan las acciones perif~ricas de la atropina Produce -shy

-un efecto antisecretor gastrico asi como una disrninuci6n de la inotilidad

-intestinal Tiene un efecto antiespasm6dico sobre la fibra muscular lisa

del tracto biliar lIMetilbromuro de Pipenzolato quita el espasmo del

tracto gastrointestinal inferior asf como el del esfinter de Oddi y puede -shy

el sindrome del colon irritable -shyser Util en el tratamiento de la ileitis en

y en otros trastornos funcionales de los tractos gastrointestinal y biliar

12 ZCu6l es la acci6n farmacol6gica del producto ESTRESULFAN - N

es el resultado deLa acci6n farmacol6gica del producto ESTRESULFAN-N

la acci6n farmacodinrnica de cada uno de los principios activos que entran

a formar parte de la f6rmula El Sulfato de Estreptornicina antibi6tico de

que actdia sobre g6rrnenes gramnegativos principairnentepequefno espectro

con efecto bactericida sobre los microorganismos productores de las infecshy

ciones y de las diarreas La Sulfadiazina un quimiotergpico de acci6n

que ataca a los pat6genos productores de -shybacteriost~tica local y general

Estos dos antirnicrobianos son sindrgicos -shylas infeccio-es del intestino

lleva a cabo su acci6n bactericidaen su acci6n ya que la Estreptonnicina

sobr -o= g-rrn-Tn e - -t6genos porque interviene alterando la permeabilidad

de la rnembrana celular v el rnetabolisrno de las proteffnas en tanto que la

con el cido para-amin3benzoico en la formaci6n del -Sulfadiazina compite (l)

acido f6lico indispensable para la sobrevida de los ricroorganis-=s 51 Ileshy

tilboruro de Pipenzolato es un anticolinfrgico que disminuye las secreciones

del est6mago y la motilidad intestinal del tracto -igestivo quitandc los espasmos

en la fibra muscular lisa del intestino EI Caolin con sus propiedades protectoshy

la materiaras absorb~ntes v astringentes y la -ectina que le forma cuerpo a

fecal hacen al producto ESTRESULFAiN-N urna aziacion sinrgica para elshy

de los niilos o de los adultos (La formatratamiento de las dia-rreas infecciosas

lleva Caolfn ni Fectinafarmac4utica Capsulas no

13 LEn qu6 enfermedades esta indicado el producto ESTRESULFAN-N Capsu-shy

las y Suspensi6n

en ----El producto ESTRESULFAN-N Capsulas y Suspensi6n esta indicado

tratamiento de padecimientos del aparato digestivo en particular en las inshy

fecciones intestinalez que se acompafien de diarreas producidas por gdrmeshy

tales como Diarreas del nes sensibles a los antimicrobianos de la f6rmula

lactante de nifics o bi~n de los adultos producidas por Escherichia coli shy

etcSalmonellas Shigellas Staphylococcus aureus Streptococcus faecalis

14 ZC6mo se presenta al pdblico el producto ESTRESULFAN-N

El producto ESTRESULFANN-N se presenta al pdblico en dos formas farma-shy

con 30 mlc~utidas Capsulas y Suspensi6n Caja con 20 c 4psulas y Frasco

en forma de suspensi6n Una cucharadita de 5 ml de la suspensi6n tiene --

LCo i- 3- oulfai -zin y 75 de Sulfato de 7streptomicina

qu6 dosis se recornienda administra-r e] producto BSTRESULFAN-N15 zA

horas dependianto del pesoAdultos 2 a 4 cipsulas cada 4

peso por dra fraccionandcNinos 12 cucharadita de Suspensicn por kilo de

la dosis y administrindola cada 4 hcras

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

acido f6lico indispensable para la sobrevida de los ricroorganis-=s 51 Ileshy

tilboruro de Pipenzolato es un anticolinfrgico que disminuye las secreciones

del est6mago y la motilidad intestinal del tracto -igestivo quitandc los espasmos

en la fibra muscular lisa del intestino EI Caolin con sus propiedades protectoshy

la materiaras absorb~ntes v astringentes y la -ectina que le forma cuerpo a

fecal hacen al producto ESTRESULFAiN-N urna aziacion sinrgica para elshy

de los niilos o de los adultos (La formatratamiento de las dia-rreas infecciosas

lleva Caolfn ni Fectinafarmac4utica Capsulas no

13 LEn qu6 enfermedades esta indicado el producto ESTRESULFAN-N Capsu-shy

las y Suspensi6n

en ----El producto ESTRESULFAN-N Capsulas y Suspensi6n esta indicado

tratamiento de padecimientos del aparato digestivo en particular en las inshy

fecciones intestinalez que se acompafien de diarreas producidas por gdrmeshy

tales como Diarreas del nes sensibles a los antimicrobianos de la f6rmula

lactante de nifics o bi~n de los adultos producidas por Escherichia coli shy

etcSalmonellas Shigellas Staphylococcus aureus Streptococcus faecalis

14 ZC6mo se presenta al pdblico el producto ESTRESULFAN-N

El producto ESTRESULFANN-N se presenta al pdblico en dos formas farma-shy

con 30 mlc~utidas Capsulas y Suspensi6n Caja con 20 c 4psulas y Frasco

en forma de suspensi6n Una cucharadita de 5 ml de la suspensi6n tiene --

LCo i- 3- oulfai -zin y 75 de Sulfato de 7streptomicina

qu6 dosis se recornienda administra-r e] producto BSTRESULFAN-N15 zA

horas dependianto del pesoAdultos 2 a 4 cipsulas cada 4

peso por dra fraccionandcNinos 12 cucharadita de Suspensicn por kilo de

la dosis y administrindola cada 4 hcras

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

- 8shy

16 4Cuales son las reacciones secundarias

E dosis elevadac puede producir cristaluria hepatitis t6kica y hernaturia

17 Tiene alguias contraindicaciones nuestrc producto EST-ESULFAI-N

Se contraidica cuando hay 72nsibilidad L 2 no de los ccmponentes de la

f6rmula En la insuficiencia renal yo hepatica Glaucoma hipertrofia shy

prosttica y pil6rica

El producto ESTRESULFADI-N Capsulas y Suspsnsi6n se administra por shy

via oral

AAVmegrl

fV

)iarrea

insitu Tratar sin perder tiempo

la diarrea con menos dosis

concentrado

La eficacia comprobada por anos en una novedosa concentraci6n de elementos activos para una respuesta efectiva

Caolin 2958 g Pectina 066 g

por cada iO0 mi

6 Menor cantidad do dosis 25 menos tomas al dia

=Contribuye eficazmen ala conformacion de las heces

Acta en el sitio donde so origino e problema

Motarda la ahsorciin do toxinoas

bro moej loIamucosa prot gendol Cohpribuy aminiizar acion poundsdeshidro

ro a ro ti If~orI to

U1 nestln nor o a tt i fi nKaopectate

Concentradogo r Mlrada ab~ sao aSUspensi6n

Un DOVO nobr ara prescihir

7

nuevo K ooPectate

~ iaconcentrado

512 anas

S3 d

36 o -~Sh Adolescentes Adultos

~~ ~120 ml

7-200

desp~ d cadd evacuacion ~ apcae FOPMLJ~~k- Kapt ___________ teCaoh29M8g~ct

Cbp 100 MI_

E una ixs~nm decaolin y pecona 8 caolin se encoentua enfmm=coale medianc una wftparaa6 medal paraec n r d- lagrar parxiculas detamaki mirm y asi Dbienm un6rea mayor deadsarci para la erli~nad6nde taunas U otros rsna nFsc

INICCIM-Kapweesit indicado endarreas do onigen no bareriana Mediame k ac6i demicente quae ca Presentci ntso i21m fIeren el caoin ylapecona Drolege la cnucosa llma~tomw y favorece la torrnacibn dehecesintestinal proporvinaou m~con=mimemes

INTERACCION MEDCAMwENTOSAKaopectare inhibe laabslarci6n deitracicfina

P1RECALICINES Xooecxateconcnradonodbe4 usarsacomasubufruta deunaaouiadateraiaderehidraimirl en niosmenare de gal con andco enpacenies con a~bsuan irnestnal No debert m~dada a

L asansa dEstA

pac-ientes ourante 2i 1cr trimestre deembaraza O71Jom~~ CONES ESPECIALES coma la adntraoi6n doiquidas par via parenteral part rehidia P a no Y A3Lateraoia concomiat

tar alas pacientes a tratamientas par aannbiftco enntcoesecifica dee ser seleczionada cuanda ezraindicada

Elemplea deKaooectate cancentraao pudieta inierfenr con[aatsercibn deotras tratamniettos asociadas rtes coma anti tle tr bidtiCOSETC almiaaad adaras cmaed eprtr u ~ acn-V0 Setecomienda consuutar atmiocad adaras e rsdedos dias minimacmaed perair mtepssa S au

Calzada deflaloan No 2962 LjqiixJtbz Twx Mid= RegNm 79301SS 04870 Mho OF mia remoer I Mid UE204421MxSu reczu mea 665

L

concentrado

La eficacia comprobada por anos en una novedosa concentraci6n de elementos activos para una respuesta efectiva

Caolin 2958 g Pectina 066 g

por cada iO0 mi

6 Menor cantidad do dosis 25 menos tomas al dia

=Contribuye eficazmen ala conformacion de las heces

Acta en el sitio donde so origino e problema

Motarda la ahsorciin do toxinoas

bro moej loIamucosa prot gendol Cohpribuy aminiizar acion poundsdeshidro

ro a ro ti If~orI to

U1 nestln nor o a tt i fi nKaopectate

Concentradogo r Mlrada ab~ sao aSUspensi6n

Un DOVO nobr ara prescihir

7

nuevo K ooPectate

~ iaconcentrado

512 anas

S3 d

36 o -~Sh Adolescentes Adultos

~~ ~120 ml

7-200

desp~ d cadd evacuacion ~ apcae FOPMLJ~~k- Kapt ___________ teCaoh29M8g~ct

Cbp 100 MI_

E una ixs~nm decaolin y pecona 8 caolin se encoentua enfmm=coale medianc una wftparaa6 medal paraec n r d- lagrar parxiculas detamaki mirm y asi Dbienm un6rea mayor deadsarci para la erli~nad6nde taunas U otros rsna nFsc

INICCIM-Kapweesit indicado endarreas do onigen no bareriana Mediame k ac6i demicente quae ca Presentci ntso i21m fIeren el caoin ylapecona Drolege la cnucosa llma~tomw y favorece la torrnacibn dehecesintestinal proporvinaou m~con=mimemes

INTERACCION MEDCAMwENTOSAKaopectare inhibe laabslarci6n deitracicfina

P1RECALICINES Xooecxateconcnradonodbe4 usarsacomasubufruta deunaaouiadateraiaderehidraimirl en niosmenare de gal con andco enpacenies con a~bsuan irnestnal No debert m~dada a

L asansa dEstA

pac-ientes ourante 2i 1cr trimestre deembaraza O71Jom~~ CONES ESPECIALES coma la adntraoi6n doiquidas par via parenteral part rehidia P a no Y A3Lateraoia concomiat

tar alas pacientes a tratamientas par aannbiftco enntcoesecifica dee ser seleczionada cuanda ezraindicada

Elemplea deKaooectate cancentraao pudieta inierfenr con[aatsercibn deotras tratamniettos asociadas rtes coma anti tle tr bidtiCOSETC almiaaad adaras cmaed eprtr u ~ acn-V0 Setecomienda consuutar atmiocad adaras e rsdedos dias minimacmaed perair mtepssa S au

Calzada deflaloan No 2962 LjqiixJtbz Twx Mid= RegNm 79301SS 04870 Mho OF mia remoer I Mid UE204421MxSu reczu mea 665

L

6 Menor cantidad do dosis 25 menos tomas al dia

=Contribuye eficazmen ala conformacion de las heces

Acta en el sitio donde so origino e problema

Motarda la ahsorciin do toxinoas

bro moej loIamucosa prot gendol Cohpribuy aminiizar acion poundsdeshidro

ro a ro ti If~orI to

U1 nestln nor o a tt i fi nKaopectate

Concentradogo r Mlrada ab~ sao aSUspensi6n

Un DOVO nobr ara prescihir

7

nuevo K ooPectate

~ iaconcentrado

512 anas

S3 d

36 o -~Sh Adolescentes Adultos

~~ ~120 ml

7-200

desp~ d cadd evacuacion ~ apcae FOPMLJ~~k- Kapt ___________ teCaoh29M8g~ct

Cbp 100 MI_

E una ixs~nm decaolin y pecona 8 caolin se encoentua enfmm=coale medianc una wftparaa6 medal paraec n r d- lagrar parxiculas detamaki mirm y asi Dbienm un6rea mayor deadsarci para la erli~nad6nde taunas U otros rsna nFsc

INICCIM-Kapweesit indicado endarreas do onigen no bareriana Mediame k ac6i demicente quae ca Presentci ntso i21m fIeren el caoin ylapecona Drolege la cnucosa llma~tomw y favorece la torrnacibn dehecesintestinal proporvinaou m~con=mimemes

INTERACCION MEDCAMwENTOSAKaopectare inhibe laabslarci6n deitracicfina

P1RECALICINES Xooecxateconcnradonodbe4 usarsacomasubufruta deunaaouiadateraiaderehidraimirl en niosmenare de gal con andco enpacenies con a~bsuan irnestnal No debert m~dada a

L asansa dEstA

pac-ientes ourante 2i 1cr trimestre deembaraza O71Jom~~ CONES ESPECIALES coma la adntraoi6n doiquidas par via parenteral part rehidia P a no Y A3Lateraoia concomiat

tar alas pacientes a tratamientas par aannbiftco enntcoesecifica dee ser seleczionada cuanda ezraindicada

Elemplea deKaooectate cancentraao pudieta inierfenr con[aatsercibn deotras tratamniettos asociadas rtes coma anti tle tr bidtiCOSETC almiaaad adaras cmaed eprtr u ~ acn-V0 Setecomienda consuutar atmiocad adaras e rsdedos dias minimacmaed perair mtepssa S au

Calzada deflaloan No 2962 LjqiixJtbz Twx Mid= RegNm 79301SS 04870 Mho OF mia remoer I Mid UE204421MxSu reczu mea 665

L

nuevo K ooPectate

~ iaconcentrado

512 anas

S3 d

36 o -~Sh Adolescentes Adultos

~~ ~120 ml

7-200

desp~ d cadd evacuacion ~ apcae FOPMLJ~~k- Kapt ___________ teCaoh29M8g~ct

Cbp 100 MI_

E una ixs~nm decaolin y pecona 8 caolin se encoentua enfmm=coale medianc una wftparaa6 medal paraec n r d- lagrar parxiculas detamaki mirm y asi Dbienm un6rea mayor deadsarci para la erli~nad6nde taunas U otros rsna nFsc

INICCIM-Kapweesit indicado endarreas do onigen no bareriana Mediame k ac6i demicente quae ca Presentci ntso i21m fIeren el caoin ylapecona Drolege la cnucosa llma~tomw y favorece la torrnacibn dehecesintestinal proporvinaou m~con=mimemes

INTERACCION MEDCAMwENTOSAKaopectare inhibe laabslarci6n deitracicfina

P1RECALICINES Xooecxateconcnradonodbe4 usarsacomasubufruta deunaaouiadateraiaderehidraimirl en niosmenare de gal con andco enpacenies con a~bsuan irnestnal No debert m~dada a

L asansa dEstA

pac-ientes ourante 2i 1cr trimestre deembaraza O71Jom~~ CONES ESPECIALES coma la adntraoi6n doiquidas par via parenteral part rehidia P a no Y A3Lateraoia concomiat

tar alas pacientes a tratamientas par aannbiftco enntcoesecifica dee ser seleczionada cuanda ezraindicada

Elemplea deKaooectate cancentraao pudieta inierfenr con[aatsercibn deotras tratamniettos asociadas rtes coma anti tle tr bidtiCOSETC almiaaad adaras cmaed eprtr u ~ acn-V0 Setecomienda consuutar atmiocad adaras e rsdedos dias minimacmaed perair mtepssa S au

Calzada deflaloan No 2962 LjqiixJtbz Twx Mid= RegNm 79301SS 04870 Mho OF mia remoer I Mid UE204421MxSu reczu mea 665

L

- - -

-- j

bull _

I

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7shy

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GOO I WN

a V4c-A71 (Clorhidrato de loperamida)

Tratamiento sintomdtico de las diarreas

(Clorhidroto de lopermida)

Comprimidos Soluci6n Gotas

ACANOL es un nuevo agente antidiarr6ico sint6tico con propiedad antiespasm6dica sobre la musculaturo lisa intestinal Produce una inhibici6n sabre el hiperperistaltismo sin efecto sobre el sistema nervioso central

Los estudios ACANOL

disponibles demostrcron la acci6n antidiarr6ica de

Suprime los espasmos en po-cos minutos

Reduce las evacuaciones desde las primeras dosis

Ayuda a impedir la deshishydrataci6n Por su amplio margen de seshyguridad es efectivo para el tratamiento en ninos adultos y ancianos -A~

Un concepto actualizado en el tratamiento

de diarreas

ACANOL no presenta resistencia cruzada

(Clorhidrato de loperamida)

Ccmprimidos Solucin Gotas

antidiarreico-Formulas Coda comprimido contiene Clorhidrato de loperamida 2 mg Excipiente cbp I comprimido

Coda 100 ml de soluci6n contlenen Clorhidrato de loperamida 20 mg Vehiculo cbp 100 ml Coda ml de soluci6n infontil (gotas) contiene Clorhidrato de loperamida Vehiculocbp

Soluci6n PESO EN KG Y EDAD

12000 a 18250 Kg (2 a 5 aros)

18250 a 25000 Kg (5 a 8 arios)

25000 a 44150 Kg (8 a 12 aros)

16 mg 1 ml

DOSIS POR TOMA

1 a 2 cucharaditas 12 a 18 mg

2 a 25 cucharaditas 18 a 25 mg

25 a 45 cucharaditas 25 a 45 mg

no narc6tico Presentaciones Comprimidos Soluci6n Soluci6n infantil (gotas)

Posologia Comprimidos

Caja con 12 comprimidos Frasco con 60 ml Frasco con 10 ml y gotero

2 comprimidos (4 mg de Clorhidroto de loperamida) al iniciar el tratamiento y I comprimi4o (2 mg) despuamps de coda evacuacion sin exceder 8 comprimidos (16 mg) en 24 horas

DOSIS MAXIMA POR DIA

3 a 6 cucharaditas 36 a 54 mg

6 a 7 cucharoditas 54 a 75 mg

75 a 8 cucharoditas 75 hasta 8 mg

O en forma general media cucharadita per coda 10 Kg de peso 2 6 3 veces par dia

Soluci6n Infantil gotas PESO EN KG Y EDAD DOSIS POR TOMA DOSIS MAXIMA POR DIA

12000 a 18250 Kg 15 a 22 gotas 45 a 66 gctas (2 a 5 arios) 12 a 18 mg 36 a 54 mg

18250 a 25000 Kg 22 a 31 gotas 66 a 93 gotas (5 a 8 argos) 18 a 25 mg 54 a 75 mg

25000 a 44150 Kg 31 a 55 gotos 93 a 100 gotas

(8 a 12 ahos) 25 a 44 mg 75 hasta 8 mg

O en forma general 1 gota par Kg de peso repartida en 2 6 3 veces par dia

Observaclones Una vez normalizadas las evacuaciones deber6 suspenderse el tratamiento Via do adminlstricl6n Oral Aistese estrictamente a las dosis seraladas

Reacclones socundarlas No se han registrado reacciones secundarias ao6n despu6s del tratamiento prolonshygado raramente se ha observado resequedad de la boca y de las mucosas Estrerimiento somnolencia n6usea v6mito dolor abdominal e ileoparalftico

Procauclones El empleo de este medicamento durante el embarazo queda bajo la responsabilidad del mdico No se administre este medicamento a nifos menores de 6 artos Una sobreclosis de este medicarnento puede ocasionar una depresidn respiratoria grave si esto sucede el paciente deber6 ser hospitalizado inmediatamente

Contralindicaclones No usar en pacientes con constipaci6n atonia intestinal obstrucci6n intestinal enterishytis toxiinfecciosas enterocolitis pseudo membranosa diarreas infecciosas o amibiana y su uso prolongado no es aconsejoble quedando a criteria del m-dico

r0

5 $00M KS S7

I 4 oo

d e Q droa r tl c

tA

~ -1 ~ ~ VN - - a-51

UUUbdvJtcoicur El artidiarreico completo BACTEMCIDA ESPECIFICO COWiTiHA

DESDE LA PRIMERA DOSIS L08 PATOGENOS INTESTIJAL f

El colistin y la furazolidona ejercen una acci6n Su elevado contenido en sulfato de bactericida conjunta contra los tres pat6genos colistin destruye a las Esch coli mds involucrados en las gastroenteritis enteropatogenas las Shigellas y las mexicanas Esch coli enteropat6gena Shigella Salmonellas responsables de las sp y Salmonella sp gastroenleritis tipicas mexicanas

Reduce ia posibilidad de emergencia de cepasresistentes al reunir dos mecanismos Actta directamente en a luz intestinal bactericidas diferentes

Disminuye la frecuencia e intensidad de la diarrea con la acci6n astringente del caolin y la bull Su nula absorci6n gastroent6ricapectina garantiza la atoxicidad terapdutica

SModera la deshidratqg6 y la perdida de]

ee rl l d Su acci6n astringente yabsorbente Suprime el c6lico intestinal agregado y atenTa el controlan rcipidamente el cuadro hiperperistaltismo intestinal diarr6ico

COILFUR ElInldlidilCO complelo

COIF lu COLFUn

Ssg-n n Tablelas Sulllo do cdoslhn quivlnltal a 6 3 mg 16 n do coh$1tnbaio

165mg 500 gC)yodohldeoiquien 150 0 mg COfhdrato de diciclomln I 65 mg 5 0mg

150 0mg shy

325mg -VoicO a Axccentpicnl cbp 5 l I I Isel COLISTIN MAGMA

Indkccclons Triiiamiento elologio j 1ntlomal o do Iss dwaoai - Fianc uiinaial ulcerbull cConall ndlcaclonos relefnc6n rlfclds elp ificc conitc loo pl6gno Inlilletflr pepticbull esteno$lnloyObslitucctdnnphlliiCododenal Ptod lnminlslt sea parilenlicungli om conhlptleoIs pStSf- Ffnsuls CodaS ol conrenan 8 3mg dscohilol bisl ono sollo IOU eco hny S00mg de cien Indicaclonie InlecobullchIas ai Phtibcmtics Aetg a alyoJo Is a menlo Iil Ftlecrioc soleundoriestieFrndmis lneiallopnealintcis ol eitnc i opnlecrlellbed o iut o lllnenl uda pot ichcol nlco i6gensShigotllop Salmonmellp pnhstpliateliasg m negaliasflectO Indrseatbli se lcilan a ienociones do plenlud pigdilcs dioesvina i-m nloVa ouilotAdnlitrado con bbldll lenlibla$ a iilbull_Con baClsilCoid Co ioltndikclooc - paciehleg hip senstbles ampIctilstin Reacclone$ secundeili NoisaIcoMlcos puwdo pioductr iaccioonctlpodisulhlem PosologlO Suspen6n 2 -3 I n g dislopalldo 61 A 2 plelenlon n POrlpi poicllcamen l no so abseoubpaotmiales Ocaslnllnone puctJenncwitlcoecJcins alUeiis84a 6oma cCoCenlOa ochawltaod ad4 pound h6te) lisn prnil nloin Tablial do 5 a tsl 4on funcOn del 0co so n s mull PNhlos 2ampno$ Ilablole U dopotlaf iqOmpopoiodacaiio Illo~tOn dljteIoinlogtinal Palagil Io2cuchatadliscad46hOAila

Bhols layoras do 12 Ao 2 lablel$ coda 6 hollsy bulldull01

0 0

le

7shy

7

o eceso

an t i t

c7

GOO I WN

a V4c-A71 (Clorhidrato de loperamida)

Tratamiento sintomdtico de las diarreas

(Clorhidroto de lopermida)

Comprimidos Soluci6n Gotas

ACANOL es un nuevo agente antidiarr6ico sint6tico con propiedad antiespasm6dica sobre la musculaturo lisa intestinal Produce una inhibici6n sabre el hiperperistaltismo sin efecto sobre el sistema nervioso central

Los estudios ACANOL

disponibles demostrcron la acci6n antidiarr6ica de

Suprime los espasmos en po-cos minutos

Reduce las evacuaciones desde las primeras dosis

Ayuda a impedir la deshishydrataci6n Por su amplio margen de seshyguridad es efectivo para el tratamiento en ninos adultos y ancianos -A~

Un concepto actualizado en el tratamiento

de diarreas

ACANOL no presenta resistencia cruzada

(Clorhidrato de loperamida)

Ccmprimidos Solucin Gotas

antidiarreico-Formulas Coda comprimido contiene Clorhidrato de loperamida 2 mg Excipiente cbp I comprimido

Coda 100 ml de soluci6n contlenen Clorhidrato de loperamida 20 mg Vehiculo cbp 100 ml Coda ml de soluci6n infontil (gotas) contiene Clorhidrato de loperamida Vehiculocbp

Soluci6n PESO EN KG Y EDAD

12000 a 18250 Kg (2 a 5 aros)

18250 a 25000 Kg (5 a 8 arios)

25000 a 44150 Kg (8 a 12 aros)

16 mg 1 ml

DOSIS POR TOMA

1 a 2 cucharaditas 12 a 18 mg

2 a 25 cucharaditas 18 a 25 mg

25 a 45 cucharaditas 25 a 45 mg

no narc6tico Presentaciones Comprimidos Soluci6n Soluci6n infantil (gotas)

Posologia Comprimidos

Caja con 12 comprimidos Frasco con 60 ml Frasco con 10 ml y gotero

2 comprimidos (4 mg de Clorhidroto de loperamida) al iniciar el tratamiento y I comprimi4o (2 mg) despuamps de coda evacuacion sin exceder 8 comprimidos (16 mg) en 24 horas

DOSIS MAXIMA POR DIA

3 a 6 cucharaditas 36 a 54 mg

6 a 7 cucharoditas 54 a 75 mg

75 a 8 cucharoditas 75 hasta 8 mg

O en forma general media cucharadita per coda 10 Kg de peso 2 6 3 veces par dia

Soluci6n Infantil gotas PESO EN KG Y EDAD DOSIS POR TOMA DOSIS MAXIMA POR DIA

12000 a 18250 Kg 15 a 22 gotas 45 a 66 gctas (2 a 5 arios) 12 a 18 mg 36 a 54 mg

18250 a 25000 Kg 22 a 31 gotas 66 a 93 gotas (5 a 8 argos) 18 a 25 mg 54 a 75 mg

25000 a 44150 Kg 31 a 55 gotos 93 a 100 gotas

(8 a 12 ahos) 25 a 44 mg 75 hasta 8 mg

O en forma general 1 gota par Kg de peso repartida en 2 6 3 veces par dia

Observaclones Una vez normalizadas las evacuaciones deber6 suspenderse el tratamiento Via do adminlstricl6n Oral Aistese estrictamente a las dosis seraladas

Reacclones socundarlas No se han registrado reacciones secundarias ao6n despu6s del tratamiento prolonshygado raramente se ha observado resequedad de la boca y de las mucosas Estrerimiento somnolencia n6usea v6mito dolor abdominal e ileoparalftico

Procauclones El empleo de este medicamento durante el embarazo queda bajo la responsabilidad del mdico No se administre este medicamento a nifos menores de 6 artos Una sobreclosis de este medicarnento puede ocasionar una depresidn respiratoria grave si esto sucede el paciente deber6 ser hospitalizado inmediatamente

Contralindicaclones No usar en pacientes con constipaci6n atonia intestinal obstrucci6n intestinal enterishytis toxiinfecciosas enterocolitis pseudo membranosa diarreas infecciosas o amibiana y su uso prolongado no es aconsejoble quedando a criteria del m-dico

r0

5 $00M KS S7

I 4 oo

d e Q droa r tl c

tA

~ -1 ~ ~ VN - - a-51

UUUbdvJtcoicur El artidiarreico completo BACTEMCIDA ESPECIFICO COWiTiHA

DESDE LA PRIMERA DOSIS L08 PATOGENOS INTESTIJAL f

El colistin y la furazolidona ejercen una acci6n Su elevado contenido en sulfato de bactericida conjunta contra los tres pat6genos colistin destruye a las Esch coli mds involucrados en las gastroenteritis enteropatogenas las Shigellas y las mexicanas Esch coli enteropat6gena Shigella Salmonellas responsables de las sp y Salmonella sp gastroenleritis tipicas mexicanas

Reduce ia posibilidad de emergencia de cepasresistentes al reunir dos mecanismos Actta directamente en a luz intestinal bactericidas diferentes

Disminuye la frecuencia e intensidad de la diarrea con la acci6n astringente del caolin y la bull Su nula absorci6n gastroent6ricapectina garantiza la atoxicidad terapdutica

SModera la deshidratqg6 y la perdida de]

ee rl l d Su acci6n astringente yabsorbente Suprime el c6lico intestinal agregado y atenTa el controlan rcipidamente el cuadro hiperperistaltismo intestinal diarr6ico

COILFUR ElInldlidilCO complelo

COIF lu COLFUn

Ssg-n n Tablelas Sulllo do cdoslhn quivlnltal a 6 3 mg 16 n do coh$1tnbaio

165mg 500 gC)yodohldeoiquien 150 0 mg COfhdrato de diciclomln I 65 mg 5 0mg

150 0mg shy

325mg -VoicO a Axccentpicnl cbp 5 l I I Isel COLISTIN MAGMA

Indkccclons Triiiamiento elologio j 1ntlomal o do Iss dwaoai - Fianc uiinaial ulcerbull cConall ndlcaclonos relefnc6n rlfclds elp ificc conitc loo pl6gno Inlilletflr pepticbull esteno$lnloyObslitucctdnnphlliiCododenal Ptod lnminlslt sea parilenlicungli om conhlptleoIs pStSf- Ffnsuls CodaS ol conrenan 8 3mg dscohilol bisl ono sollo IOU eco hny S00mg de cien Indicaclonie InlecobullchIas ai Phtibcmtics Aetg a alyoJo Is a menlo Iil Ftlecrioc soleundoriestieFrndmis lneiallopnealintcis ol eitnc i opnlecrlellbed o iut o lllnenl uda pot ichcol nlco i6gensShigotllop Salmonmellp pnhstpliateliasg m negaliasflectO Indrseatbli se lcilan a ienociones do plenlud pigdilcs dioesvina i-m nloVa ouilotAdnlitrado con bbldll lenlibla$ a iilbull_Con baClsilCoid Co ioltndikclooc - paciehleg hip senstbles ampIctilstin Reacclone$ secundeili NoisaIcoMlcos puwdo pioductr iaccioonctlpodisulhlem PosologlO Suspen6n 2 -3 I n g dislopalldo 61 A 2 plelenlon n POrlpi poicllcamen l no so abseoubpaotmiales Ocaslnllnone puctJenncwitlcoecJcins alUeiis84a 6oma cCoCenlOa ochawltaod ad4 pound h6te) lisn prnil nloin Tablial do 5 a tsl 4on funcOn del 0co so n s mull PNhlos 2ampno$ Ilablole U dopotlaf iqOmpopoiodacaiio Illo~tOn dljteIoinlogtinal Palagil Io2cuchatadliscad46hOAila

Bhols layoras do 12 Ao 2 lablel$ coda 6 hollsy bulldull01

(Clorhidroto de lopermida)

Comprimidos Soluci6n Gotas

ACANOL es un nuevo agente antidiarr6ico sint6tico con propiedad antiespasm6dica sobre la musculaturo lisa intestinal Produce una inhibici6n sabre el hiperperistaltismo sin efecto sobre el sistema nervioso central

Los estudios ACANOL

disponibles demostrcron la acci6n antidiarr6ica de

Suprime los espasmos en po-cos minutos

Reduce las evacuaciones desde las primeras dosis

Ayuda a impedir la deshishydrataci6n Por su amplio margen de seshyguridad es efectivo para el tratamiento en ninos adultos y ancianos -A~

Un concepto actualizado en el tratamiento

de diarreas

ACANOL no presenta resistencia cruzada

(Clorhidrato de loperamida)

Ccmprimidos Solucin Gotas

antidiarreico-Formulas Coda comprimido contiene Clorhidrato de loperamida 2 mg Excipiente cbp I comprimido

Coda 100 ml de soluci6n contlenen Clorhidrato de loperamida 20 mg Vehiculo cbp 100 ml Coda ml de soluci6n infontil (gotas) contiene Clorhidrato de loperamida Vehiculocbp

Soluci6n PESO EN KG Y EDAD

12000 a 18250 Kg (2 a 5 aros)

18250 a 25000 Kg (5 a 8 arios)

25000 a 44150 Kg (8 a 12 aros)

16 mg 1 ml

DOSIS POR TOMA

1 a 2 cucharaditas 12 a 18 mg

2 a 25 cucharaditas 18 a 25 mg

25 a 45 cucharaditas 25 a 45 mg

no narc6tico Presentaciones Comprimidos Soluci6n Soluci6n infantil (gotas)

Posologia Comprimidos

Caja con 12 comprimidos Frasco con 60 ml Frasco con 10 ml y gotero

2 comprimidos (4 mg de Clorhidroto de loperamida) al iniciar el tratamiento y I comprimi4o (2 mg) despuamps de coda evacuacion sin exceder 8 comprimidos (16 mg) en 24 horas

DOSIS MAXIMA POR DIA

3 a 6 cucharaditas 36 a 54 mg

6 a 7 cucharoditas 54 a 75 mg

75 a 8 cucharoditas 75 hasta 8 mg

O en forma general media cucharadita per coda 10 Kg de peso 2 6 3 veces par dia

Soluci6n Infantil gotas PESO EN KG Y EDAD DOSIS POR TOMA DOSIS MAXIMA POR DIA

12000 a 18250 Kg 15 a 22 gotas 45 a 66 gctas (2 a 5 arios) 12 a 18 mg 36 a 54 mg

18250 a 25000 Kg 22 a 31 gotas 66 a 93 gotas (5 a 8 argos) 18 a 25 mg 54 a 75 mg

25000 a 44150 Kg 31 a 55 gotos 93 a 100 gotas

(8 a 12 ahos) 25 a 44 mg 75 hasta 8 mg

O en forma general 1 gota par Kg de peso repartida en 2 6 3 veces par dia

Observaclones Una vez normalizadas las evacuaciones deber6 suspenderse el tratamiento Via do adminlstricl6n Oral Aistese estrictamente a las dosis seraladas

Reacclones socundarlas No se han registrado reacciones secundarias ao6n despu6s del tratamiento prolonshygado raramente se ha observado resequedad de la boca y de las mucosas Estrerimiento somnolencia n6usea v6mito dolor abdominal e ileoparalftico

Procauclones El empleo de este medicamento durante el embarazo queda bajo la responsabilidad del mdico No se administre este medicamento a nifos menores de 6 artos Una sobreclosis de este medicarnento puede ocasionar una depresidn respiratoria grave si esto sucede el paciente deber6 ser hospitalizado inmediatamente

Contralindicaclones No usar en pacientes con constipaci6n atonia intestinal obstrucci6n intestinal enterishytis toxiinfecciosas enterocolitis pseudo membranosa diarreas infecciosas o amibiana y su uso prolongado no es aconsejoble quedando a criteria del m-dico

r0

5 $00M KS S7

I 4 oo

d e Q droa r tl c

tA

~ -1 ~ ~ VN - - a-51

UUUbdvJtcoicur El artidiarreico completo BACTEMCIDA ESPECIFICO COWiTiHA

DESDE LA PRIMERA DOSIS L08 PATOGENOS INTESTIJAL f

El colistin y la furazolidona ejercen una acci6n Su elevado contenido en sulfato de bactericida conjunta contra los tres pat6genos colistin destruye a las Esch coli mds involucrados en las gastroenteritis enteropatogenas las Shigellas y las mexicanas Esch coli enteropat6gena Shigella Salmonellas responsables de las sp y Salmonella sp gastroenleritis tipicas mexicanas

Reduce ia posibilidad de emergencia de cepasresistentes al reunir dos mecanismos Actta directamente en a luz intestinal bactericidas diferentes

Disminuye la frecuencia e intensidad de la diarrea con la acci6n astringente del caolin y la bull Su nula absorci6n gastroent6ricapectina garantiza la atoxicidad terapdutica

SModera la deshidratqg6 y la perdida de]

ee rl l d Su acci6n astringente yabsorbente Suprime el c6lico intestinal agregado y atenTa el controlan rcipidamente el cuadro hiperperistaltismo intestinal diarr6ico

COILFUR ElInldlidilCO complelo

COIF lu COLFUn

Ssg-n n Tablelas Sulllo do cdoslhn quivlnltal a 6 3 mg 16 n do coh$1tnbaio

165mg 500 gC)yodohldeoiquien 150 0 mg COfhdrato de diciclomln I 65 mg 5 0mg

150 0mg shy

325mg -VoicO a Axccentpicnl cbp 5 l I I Isel COLISTIN MAGMA

Indkccclons Triiiamiento elologio j 1ntlomal o do Iss dwaoai - Fianc uiinaial ulcerbull cConall ndlcaclonos relefnc6n rlfclds elp ificc conitc loo pl6gno Inlilletflr pepticbull esteno$lnloyObslitucctdnnphlliiCododenal Ptod lnminlslt sea parilenlicungli om conhlptleoIs pStSf- Ffnsuls CodaS ol conrenan 8 3mg dscohilol bisl ono sollo IOU eco hny S00mg de cien Indicaclonie InlecobullchIas ai Phtibcmtics Aetg a alyoJo Is a menlo Iil Ftlecrioc soleundoriestieFrndmis lneiallopnealintcis ol eitnc i opnlecrlellbed o iut o lllnenl uda pot ichcol nlco i6gensShigotllop Salmonmellp pnhstpliateliasg m negaliasflectO Indrseatbli se lcilan a ienociones do plenlud pigdilcs dioesvina i-m nloVa ouilotAdnlitrado con bbldll lenlibla$ a iilbull_Con baClsilCoid Co ioltndikclooc - paciehleg hip senstbles ampIctilstin Reacclone$ secundeili NoisaIcoMlcos puwdo pioductr iaccioonctlpodisulhlem PosologlO Suspen6n 2 -3 I n g dislopalldo 61 A 2 plelenlon n POrlpi poicllcamen l no so abseoubpaotmiales Ocaslnllnone puctJenncwitlcoecJcins alUeiis84a 6oma cCoCenlOa ochawltaod ad4 pound h6te) lisn prnil nloin Tablial do 5 a tsl 4on funcOn del 0co so n s mull PNhlos 2ampno$ Ilablole U dopotlaf iqOmpopoiodacaiio Illo~tOn dljteIoinlogtinal Palagil Io2cuchatadliscad46hOAila

Bhols layoras do 12 Ao 2 lablel$ coda 6 hollsy bulldull01

(Clorhidrato de loperamida)

Ccmprimidos Solucin Gotas

antidiarreico-Formulas Coda comprimido contiene Clorhidrato de loperamida 2 mg Excipiente cbp I comprimido

Coda 100 ml de soluci6n contlenen Clorhidrato de loperamida 20 mg Vehiculo cbp 100 ml Coda ml de soluci6n infontil (gotas) contiene Clorhidrato de loperamida Vehiculocbp

Soluci6n PESO EN KG Y EDAD

12000 a 18250 Kg (2 a 5 aros)

18250 a 25000 Kg (5 a 8 arios)

25000 a 44150 Kg (8 a 12 aros)

16 mg 1 ml

DOSIS POR TOMA

1 a 2 cucharaditas 12 a 18 mg

2 a 25 cucharaditas 18 a 25 mg

25 a 45 cucharaditas 25 a 45 mg

no narc6tico Presentaciones Comprimidos Soluci6n Soluci6n infantil (gotas)

Posologia Comprimidos

Caja con 12 comprimidos Frasco con 60 ml Frasco con 10 ml y gotero

2 comprimidos (4 mg de Clorhidroto de loperamida) al iniciar el tratamiento y I comprimi4o (2 mg) despuamps de coda evacuacion sin exceder 8 comprimidos (16 mg) en 24 horas

DOSIS MAXIMA POR DIA

3 a 6 cucharaditas 36 a 54 mg

6 a 7 cucharoditas 54 a 75 mg

75 a 8 cucharoditas 75 hasta 8 mg

O en forma general media cucharadita per coda 10 Kg de peso 2 6 3 veces par dia

Soluci6n Infantil gotas PESO EN KG Y EDAD DOSIS POR TOMA DOSIS MAXIMA POR DIA

12000 a 18250 Kg 15 a 22 gotas 45 a 66 gctas (2 a 5 arios) 12 a 18 mg 36 a 54 mg

18250 a 25000 Kg 22 a 31 gotas 66 a 93 gotas (5 a 8 argos) 18 a 25 mg 54 a 75 mg

25000 a 44150 Kg 31 a 55 gotos 93 a 100 gotas

(8 a 12 ahos) 25 a 44 mg 75 hasta 8 mg

O en forma general 1 gota par Kg de peso repartida en 2 6 3 veces par dia

Observaclones Una vez normalizadas las evacuaciones deber6 suspenderse el tratamiento Via do adminlstricl6n Oral Aistese estrictamente a las dosis seraladas

Reacclones socundarlas No se han registrado reacciones secundarias ao6n despu6s del tratamiento prolonshygado raramente se ha observado resequedad de la boca y de las mucosas Estrerimiento somnolencia n6usea v6mito dolor abdominal e ileoparalftico

Procauclones El empleo de este medicamento durante el embarazo queda bajo la responsabilidad del mdico No se administre este medicamento a nifos menores de 6 artos Una sobreclosis de este medicarnento puede ocasionar una depresidn respiratoria grave si esto sucede el paciente deber6 ser hospitalizado inmediatamente

Contralindicaclones No usar en pacientes con constipaci6n atonia intestinal obstrucci6n intestinal enterishytis toxiinfecciosas enterocolitis pseudo membranosa diarreas infecciosas o amibiana y su uso prolongado no es aconsejoble quedando a criteria del m-dico

r0

5 $00M KS S7

I 4 oo

d e Q droa r tl c

tA

~ -1 ~ ~ VN - - a-51

UUUbdvJtcoicur El artidiarreico completo BACTEMCIDA ESPECIFICO COWiTiHA

DESDE LA PRIMERA DOSIS L08 PATOGENOS INTESTIJAL f

El colistin y la furazolidona ejercen una acci6n Su elevado contenido en sulfato de bactericida conjunta contra los tres pat6genos colistin destruye a las Esch coli mds involucrados en las gastroenteritis enteropatogenas las Shigellas y las mexicanas Esch coli enteropat6gena Shigella Salmonellas responsables de las sp y Salmonella sp gastroenleritis tipicas mexicanas

Reduce ia posibilidad de emergencia de cepasresistentes al reunir dos mecanismos Actta directamente en a luz intestinal bactericidas diferentes

Disminuye la frecuencia e intensidad de la diarrea con la acci6n astringente del caolin y la bull Su nula absorci6n gastroent6ricapectina garantiza la atoxicidad terapdutica

SModera la deshidratqg6 y la perdida de]

ee rl l d Su acci6n astringente yabsorbente Suprime el c6lico intestinal agregado y atenTa el controlan rcipidamente el cuadro hiperperistaltismo intestinal diarr6ico

COILFUR ElInldlidilCO complelo

COIF lu COLFUn

Ssg-n n Tablelas Sulllo do cdoslhn quivlnltal a 6 3 mg 16 n do coh$1tnbaio

165mg 500 gC)yodohldeoiquien 150 0 mg COfhdrato de diciclomln I 65 mg 5 0mg

150 0mg shy

325mg -VoicO a Axccentpicnl cbp 5 l I I Isel COLISTIN MAGMA

Indkccclons Triiiamiento elologio j 1ntlomal o do Iss dwaoai - Fianc uiinaial ulcerbull cConall ndlcaclonos relefnc6n rlfclds elp ificc conitc loo pl6gno Inlilletflr pepticbull esteno$lnloyObslitucctdnnphlliiCododenal Ptod lnminlslt sea parilenlicungli om conhlptleoIs pStSf- Ffnsuls CodaS ol conrenan 8 3mg dscohilol bisl ono sollo IOU eco hny S00mg de cien Indicaclonie InlecobullchIas ai Phtibcmtics Aetg a alyoJo Is a menlo Iil Ftlecrioc soleundoriestieFrndmis lneiallopnealintcis ol eitnc i opnlecrlellbed o iut o lllnenl uda pot ichcol nlco i6gensShigotllop Salmonmellp pnhstpliateliasg m negaliasflectO Indrseatbli se lcilan a ienociones do plenlud pigdilcs dioesvina i-m nloVa ouilotAdnlitrado con bbldll lenlibla$ a iilbull_Con baClsilCoid Co ioltndikclooc - paciehleg hip senstbles ampIctilstin Reacclone$ secundeili NoisaIcoMlcos puwdo pioductr iaccioonctlpodisulhlem PosologlO Suspen6n 2 -3 I n g dislopalldo 61 A 2 plelenlon n POrlpi poicllcamen l no so abseoubpaotmiales Ocaslnllnone puctJenncwitlcoecJcins alUeiis84a 6oma cCoCenlOa ochawltaod ad4 pound h6te) lisn prnil nloin Tablial do 5 a tsl 4on funcOn del 0co so n s mull PNhlos 2ampno$ Ilablole U dopotlaf iqOmpopoiodacaiio Illo~tOn dljteIoinlogtinal Palagil Io2cuchatadliscad46hOAila

Bhols layoras do 12 Ao 2 lablel$ coda 6 hollsy bulldull01

5 $00M KS S7

I 4 oo

d e Q droa r tl c

tA

~ -1 ~ ~ VN - - a-51

UUUbdvJtcoicur El artidiarreico completo BACTEMCIDA ESPECIFICO COWiTiHA

DESDE LA PRIMERA DOSIS L08 PATOGENOS INTESTIJAL f

El colistin y la furazolidona ejercen una acci6n Su elevado contenido en sulfato de bactericida conjunta contra los tres pat6genos colistin destruye a las Esch coli mds involucrados en las gastroenteritis enteropatogenas las Shigellas y las mexicanas Esch coli enteropat6gena Shigella Salmonellas responsables de las sp y Salmonella sp gastroenleritis tipicas mexicanas

Reduce ia posibilidad de emergencia de cepasresistentes al reunir dos mecanismos Actta directamente en a luz intestinal bactericidas diferentes

Disminuye la frecuencia e intensidad de la diarrea con la acci6n astringente del caolin y la bull Su nula absorci6n gastroent6ricapectina garantiza la atoxicidad terapdutica

SModera la deshidratqg6 y la perdida de]

ee rl l d Su acci6n astringente yabsorbente Suprime el c6lico intestinal agregado y atenTa el controlan rcipidamente el cuadro hiperperistaltismo intestinal diarr6ico

COILFUR ElInldlidilCO complelo

COIF lu COLFUn

Ssg-n n Tablelas Sulllo do cdoslhn quivlnltal a 6 3 mg 16 n do coh$1tnbaio

165mg 500 gC)yodohldeoiquien 150 0 mg COfhdrato de diciclomln I 65 mg 5 0mg

150 0mg shy

325mg -VoicO a Axccentpicnl cbp 5 l I I Isel COLISTIN MAGMA

Indkccclons Triiiamiento elologio j 1ntlomal o do Iss dwaoai - Fianc uiinaial ulcerbull cConall ndlcaclonos relefnc6n rlfclds elp ificc conitc loo pl6gno Inlilletflr pepticbull esteno$lnloyObslitucctdnnphlliiCododenal Ptod lnminlslt sea parilenlicungli om conhlptleoIs pStSf- Ffnsuls CodaS ol conrenan 8 3mg dscohilol bisl ono sollo IOU eco hny S00mg de cien Indicaclonie InlecobullchIas ai Phtibcmtics Aetg a alyoJo Is a menlo Iil Ftlecrioc soleundoriestieFrndmis lneiallopnealintcis ol eitnc i opnlecrlellbed o iut o lllnenl uda pot ichcol nlco i6gensShigotllop Salmonmellp pnhstpliateliasg m negaliasflectO Indrseatbli se lcilan a ienociones do plenlud pigdilcs dioesvina i-m nloVa ouilotAdnlitrado con bbldll lenlibla$ a iilbull_Con baClsilCoid Co ioltndikclooc - paciehleg hip senstbles ampIctilstin Reacclone$ secundeili NoisaIcoMlcos puwdo pioductr iaccioonctlpodisulhlem PosologlO Suspen6n 2 -3 I n g dislopalldo 61 A 2 plelenlon n POrlpi poicllcamen l no so abseoubpaotmiales Ocaslnllnone puctJenncwitlcoecJcins alUeiis84a 6oma cCoCenlOa ochawltaod ad4 pound h6te) lisn prnil nloin Tablial do 5 a tsl 4on funcOn del 0co so n s mull PNhlos 2ampno$ Ilablole U dopotlaf iqOmpopoiodacaiio Illo~tOn dljteIoinlogtinal Palagil Io2cuchatadliscad46hOAila

Bhols layoras do 12 Ao 2 lablel$ coda 6 hollsy bulldull01

UUUbdvJtcoicur El artidiarreico completo BACTEMCIDA ESPECIFICO COWiTiHA

DESDE LA PRIMERA DOSIS L08 PATOGENOS INTESTIJAL f

El colistin y la furazolidona ejercen una acci6n Su elevado contenido en sulfato de bactericida conjunta contra los tres pat6genos colistin destruye a las Esch coli mds involucrados en las gastroenteritis enteropatogenas las Shigellas y las mexicanas Esch coli enteropat6gena Shigella Salmonellas responsables de las sp y Salmonella sp gastroenleritis tipicas mexicanas

Reduce ia posibilidad de emergencia de cepasresistentes al reunir dos mecanismos Actta directamente en a luz intestinal bactericidas diferentes

Disminuye la frecuencia e intensidad de la diarrea con la acci6n astringente del caolin y la bull Su nula absorci6n gastroent6ricapectina garantiza la atoxicidad terapdutica

SModera la deshidratqg6 y la perdida de]

ee rl l d Su acci6n astringente yabsorbente Suprime el c6lico intestinal agregado y atenTa el controlan rcipidamente el cuadro hiperperistaltismo intestinal diarr6ico

COILFUR ElInldlidilCO complelo

COIF lu COLFUn

Ssg-n n Tablelas Sulllo do cdoslhn quivlnltal a 6 3 mg 16 n do coh$1tnbaio

165mg 500 gC)yodohldeoiquien 150 0 mg COfhdrato de diciclomln I 65 mg 5 0mg

150 0mg shy

325mg -VoicO a Axccentpicnl cbp 5 l I I Isel COLISTIN MAGMA

Indkccclons Triiiamiento elologio j 1ntlomal o do Iss dwaoai - Fianc uiinaial ulcerbull cConall ndlcaclonos relefnc6n rlfclds elp ificc conitc loo pl6gno Inlilletflr pepticbull esteno$lnloyObslitucctdnnphlliiCododenal Ptod lnminlslt sea parilenlicungli om conhlptleoIs pStSf- Ffnsuls CodaS ol conrenan 8 3mg dscohilol bisl ono sollo IOU eco hny S00mg de cien Indicaclonie InlecobullchIas ai Phtibcmtics Aetg a alyoJo Is a menlo Iil Ftlecrioc soleundoriestieFrndmis lneiallopnealintcis ol eitnc i opnlecrlellbed o iut o lllnenl uda pot ichcol nlco i6gensShigotllop Salmonmellp pnhstpliateliasg m negaliasflectO Indrseatbli se lcilan a ienociones do plenlud pigdilcs dioesvina i-m nloVa ouilotAdnlitrado con bbldll lenlibla$ a iilbull_Con baClsilCoid Co ioltndikclooc - paciehleg hip senstbles ampIctilstin Reacclone$ secundeili NoisaIcoMlcos puwdo pioductr iaccioonctlpodisulhlem PosologlO Suspen6n 2 -3 I n g dislopalldo 61 A 2 plelenlon n POrlpi poicllcamen l no so abseoubpaotmiales Ocaslnllnone puctJenncwitlcoecJcins alUeiis84a 6oma cCoCenlOa ochawltaod ad4 pound h6te) lisn prnil nloin Tablial do 5 a tsl 4on funcOn del 0co so n s mull PNhlos 2ampno$ Ilablole U dopotlaf iqOmpopoiodacaiio Illo~tOn dljteIoinlogtinal Palagil Io2cuchatadliscad46hOAila

Bhols layoras do 12 Ao 2 lablel$ coda 6 hollsy bulldull01

ANNEX 4

a~-~ 11--~984

__t__ V -4-4j ti 0) L

- -gt - - 18 2

sector alud

ANTIDIARREICOS

---- ------- -- _080

CLA]VL (EN T IRA INDIC ACISN ISNOhIHR1Y (GINIRICU ASIS VW VIAESLXTACION IL((S INDISEAHESY PR X D MINISTRACION IN )ICA(I( )NIS II( (C ICI )NISi IN1I1A(( I()N

FArlMALOI(O(ICA euro

1261 DIFENOXILATO Aduhtos Diarreas no infecciosasY ATROPINA

Uso en lactances yUna a seis rabletas en 24 nus menores deMFMG Tableses Diarreasans in feccio (1) Cada tableta conriene Bucal sasrisClorhidraro de difenuxilaro Emerucolitis pseu )25 mg

dmembranosaSulfato dc acropina 0025 mg (1) Glaucoa (1sHfpcr~rofia pus t

Envase con 10 fica (I) Estensis pil6rica (1)lnsuficicncia cardiaca (1) Administraci6n si muhinca con seshydances del sistema nerviso central (1)Insuficiencia hepiica (1) Midriasis (2)Impotencia (2)Sequedad de boca y mucosas (2) Taquicardia (2)Ccfalalgia (2)No se recomienda su administracidn prulhngRda (3) El uso concumi tante con inhibidoshyres ac la monoamishynooxidasa puede precipitar crisis hishypertensiva (4)

1262 CAOLIN Y PECTINA Aduhos Diarrea Esrefiimiento pr

MFMG Suspensi6n bucal Una a dos cucharadas (15 uso prolongado (2)ml) cada 4 horas

Cada 5 ml concienen Caolin 986 mg Lacantes Pectina 22 mg

Dos a seis cucharadiras (5Envase con 120 ml sin caja ml) en 24 horas

PreescUlares

Cuatro a ocho cucharadi Us (5 ml) en 24 horas

Bucal

166

a~-~ 11--~984

__t__ V -4-4j ti 0) L

- -gt - - 18 2

sector alud

ANTIDIARREICOS

---- ------- -- _080

CLA]VL (EN T IRA INDIC ACISN ISNOhIHR1Y (GINIRICU ASIS VW VIAESLXTACION IL((S INDISEAHESY PR X D MINISTRACION IN )ICA(I( )NIS II( (C ICI )NISi IN1I1A(( I()N

FArlMALOI(O(ICA euro

1261 DIFENOXILATO Aduhtos Diarreas no infecciosasY ATROPINA

Uso en lactances yUna a seis rabletas en 24 nus menores deMFMG Tableses Diarreasans in feccio (1) Cada tableta conriene Bucal sasrisClorhidraro de difenuxilaro Emerucolitis pseu )25 mg

dmembranosaSulfato dc acropina 0025 mg (1) Glaucoa (1sHfpcr~rofia pus t

Envase con 10 fica (I) Estensis pil6rica (1)lnsuficicncia cardiaca (1) Administraci6n si muhinca con seshydances del sistema nerviso central (1)Insuficiencia hepiica (1) Midriasis (2)Impotencia (2)Sequedad de boca y mucosas (2) Taquicardia (2)Ccfalalgia (2)No se recomienda su administracidn prulhngRda (3) El uso concumi tante con inhibidoshyres ac la monoamishynooxidasa puede precipitar crisis hishypertensiva (4)

1262 CAOLIN Y PECTINA Aduhos Diarrea Esrefiimiento pr

MFMG Suspensi6n bucal Una a dos cucharadas (15 uso prolongado (2)ml) cada 4 horas

Cada 5 ml concienen Caolin 986 mg Lacantes Pectina 22 mg

Dos a seis cucharadiras (5Envase con 120 ml sin caja ml) en 24 horas

PreescUlares

Cuatro a ocho cucharadi Us (5 ml) en 24 horas

Bucal

166

ANTIDIARREICOS

---- ------- -- _080

CLA]VL (EN T IRA INDIC ACISN ISNOhIHR1Y (GINIRICU ASIS VW VIAESLXTACION IL((S INDISEAHESY PR X D MINISTRACION IN )ICA(I( )NIS II( (C ICI )NISi IN1I1A(( I()N

FArlMALOI(O(ICA euro

1261 DIFENOXILATO Aduhtos Diarreas no infecciosasY ATROPINA

Uso en lactances yUna a seis rabletas en 24 nus menores deMFMG Tableses Diarreasans in feccio (1) Cada tableta conriene Bucal sasrisClorhidraro de difenuxilaro Emerucolitis pseu )25 mg

dmembranosaSulfato dc acropina 0025 mg (1) Glaucoa (1sHfpcr~rofia pus t

Envase con 10 fica (I) Estensis pil6rica (1)lnsuficicncia cardiaca (1) Administraci6n si muhinca con seshydances del sistema nerviso central (1)Insuficiencia hepiica (1) Midriasis (2)Impotencia (2)Sequedad de boca y mucosas (2) Taquicardia (2)Ccfalalgia (2)No se recomienda su administracidn prulhngRda (3) El uso concumi tante con inhibidoshyres ac la monoamishynooxidasa puede precipitar crisis hishypertensiva (4)

1262 CAOLIN Y PECTINA Aduhos Diarrea Esrefiimiento pr

MFMG Suspensi6n bucal Una a dos cucharadas (15 uso prolongado (2)ml) cada 4 horas

Cada 5 ml concienen Caolin 986 mg Lacantes Pectina 22 mg

Dos a seis cucharadiras (5Envase con 120 ml sin caja ml) en 24 horas

PreescUlares

Cuatro a ocho cucharadi Us (5 ml) en 24 horas

Bucal

166