Chapter 5 - JBLearning

Chapter Outline5-1 Information on a Medication Label

A. Generic NameB. Trade NameC. FormD. Dosage StrengthE. Combination MedicationF. Total Number, Volume, or Net WeightG. Multiple-Dose and Single-Dose PackagingH. Route of AdministrationI. Reconstitution InstructionsJ. WarningsK. Controlled Substance ScheduleL. Storage InformationM. Manufacturing Information

5-2 Information on a Medication Package Insert

learning OutCOmesUpon completion of the chapter, the student will be able to:

5-1 Differentiate information on a medication label.

5-2 Identify information on a medication package insert.

Key termsbar codecombination medication

concentrationcontrol numbercontrolled substance

controlled substance schedule

dosage strength

Chapter 5Interpretation of Medication

Labels and Package Inserts

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© Jones & Bartlett Learning, LLC. NOT FOR SALE OR DISTRIBUTION

© Jones & Bartlett Learning, LLCNOT FOR SALE OR DISTRIBUTION




















intrODuCtiOnTo safely administer medications, the nurse must be able to identify essential information on the medica-tion label and within the package insert. The label will reveal the drug name, form, dosage strength, total number or volume in the container, route of administration, storage information, warnings, manufacturing information, and, if applicable, reconstitution information and control schedule. The package insert will pro-vide more complete information about the drug, including the chemical and physical description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, adverse reactions, overdos-age, dosage and administration, preparation for administration, and manufacturer supply information. Some-times the label will make reference to the package insert for additional information not included on the label.

5-1 Information on a Medication Label

generic nameThe generic name is the nonproprietary name assigned to the active substance of a medication. This name is registered with the United States Pharmacopeia for inclusion in the United States Pharmacopeia—National

dosage unitgeneric namelot numbermultiple dosenational Drug Code (nDC)net weight

reconstitutionsingle dosesingle usesupply/supply dosage/supply

dosetotal number

total volumetrade nameunit doseUnited States Pharmacopeia—

National Formulary (USP-NF)warning

Case Consideration … What’s on a label?The patient has an order for ofloxacin: 2 drops right eye. The student nurse was supplied a bottle with the following label.

INSTRUCTIONS:For indications, directions and precautionssee package insert.

CONTAINS:Active:Ofloxacin 0.3% (3 mg /mL).

Preservative:Benzalkonium chloride (0.0025%)

Store at 20–25°C (68–77°F).[See USP Controlled Room Temperature].

NDC 60505-0363-1

FOR USE IN EARS ONLY

OfloxacinOTIC Solution

0.3%STERILE

Rx Only

5 mL

2738

39

(01)0(03)60505036318

Should the student nurse administer this medication?

116 Chapter 5 Interpretation of Medication Labels and Package Inserts

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Formulary (USP-NF), a book that contains standards for medicines, dosage forms, drug substances, excipients (inactive substances), medical devices, and dietary supplements (USP-NF, 2014). This name is not specific to the manufacturer. Medications are usually ordered by generic name.

trade nameThe trade name, also called a brand name, is the name that the manufacturer gives a medication to identify it as made by the manufacturer. This name is registered with the U.S. Department of Commerce, Patent and Trade-mark Office by the manufacturer, so that no other pharmaceutical company can use the same name. The trade name brands the medication and is used to market the medication. The symbol ® for registered trademark or ™ for trademark follows the trade name (see Figure 5-5). It is customary for the trade name to be printed in larger font, above the generic name. Common practice is to capitalize a trade name, while the generic name appears in lower-case letters. If there is only one name on the medication, it is the generic name, as by law it must appear on every drug label.

FormMedications are available in a variety of forms:

◾ Solids, such as capsules, tablets, gelcaps, and suppositories

◾ Liquids, such as oral liquids, injectable liquids, inhalants, drops, sprays, and mists

◾ Other forms, such as creams, ointments, and patches

Dosage strengthThe dosage strength (also referred to as the supply, supply dosage, or supply dose or concentra-tion) is the amount of medication in each dosage unit (e.g., 325 mg per tablet, 80 mg per mL, 200 mcg per metered spray). The dosage strength must include both the amount of medication (325 mg) and the unit of delivery (per tablet or per 5 mL). The dosage strength of the same medication may vary among age groups (Figures 5-1 and 5-2).

Figure 5-1 The dosage strength of this ibuprofen preparation (50 mg/1.25 mL) is very concentrated, requiring smaller volumes to be administered. This facilitates the infant consuming the entire dose.

USUAL DOSAGE:

See accompanying

for complete presenti

(68° to 77°F)Store at 20° to 25°Creach of childrenmedication out of theKeep this and all

dose otherwise useon chart below. IfShake well before usDirections:

0.5 FL OZ (15 mL)

For ages 6 mos. to 23 mos.Infants’ Concentrated drops

Berry Flavor

Pain Reliever/Fever Reducer(NSAID)

Oral Suspension

OPEN to read all warnings

Ibuprofen50 mg per 1.25 mL

4 FL OZ (120 mL) Rx only

USUAL DOSAGE: See Package Insert forFOR ORAL USE ONLY - NOT TO BE INJECTSTORAGE: Store at 25°C (77°F); excursionKeep in secure area and protect from div

PHARMACIST: Dispense the enclosed me

NDC 10768-7019-1

ORAL SUSPENSION USPIBUPROFEN

100 mg/5 mL

Figure 5-2 The dosage strength of this ibuprofen preparation (100 mg/5 mL) is less concentrated than the infant preparation.

5-1 Information on a Medication Label 117

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Dosage unit refers to the quantity of solid or liquid in which the supplied dose is contained. When dosage strength is expressed as a percentage, the amount of medication is always measured in grams, and the dosage unit is always 100 mL for liquid medications or 100 g for solid or semisolid medications, such as creams and ointments (Figure 5-6). Dosage strength does not refer to the amount of medication in the container.

Combination medicationA combination medication is a combination of two or more medications in one form. For example, ampicillin and sulbactam 1.5 g is a combination of ampicillin 1 g and sulbactam 0.5 g per vial (Figure 5-3). The generic name and dosage strength of each medication are always listed on the label, under the trade name of the combination medication.

total number, Volume, or net WeightThe total number, total volume, and net weight refer to the total amount of the medication form within the container, not dosage strength. That is to say, the total number refers to the number of tablets, supposi-tories, capsules, or other forms/units in the container (Figure 5-4) or the total number of milliliters in the bottle (Figure 5-5). The total number, total volume, and net weight do not refer to the number of doses or the number of milligrams in the container. Creams and ointments are sized by net weight (Figure 5-6). Weight should not be confused with dosage strength (medication weight per unit of measurement). unit dose packages of medications contain enough medication for one dose. When the unit dose package con-tains only one tablet (or other form of solid medication) the total number may be omitted, and the dosage strength is for the single tablet within the package.

Figure 5-3 Ampicillin and sulbactam for injection, USP 1.5 g is a generic combination medication. The two generic names and dosage strengths are listed.

WarnIng!Follow Storage Information

Opening the multiple-dose container may shorten the expiration time—for example, a medication that has an expiration date 1 year away may need to be discarded 30 days after opening. Always read the storage information on the label.

(01)00325021142202


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Figure 5-4 The total number of tablets in this bottle of Singulair is 90 tablets, and the dosage strength is 10 mg per tablet.

NDC 0006-0117-31

90 Tablets

Montelukast sodiumTablets For Pediatric Patients 6–14 Yearsof Age

Store at 25°C (77°F), excursions permittedto 15–30°C (59–86°F) [see USP ControlledRoom Temperature]. Protect from moistureand light. Store in original package.

USUAL DOSAGE: See accompanying circular.

Each tablet contains 10.4 mgMontelukast Sodium equivalent to10 mg Montelukast.

Rx o

nly

Lot:

0 0 0 6 – 0 1 1 7 – 3 13N

2 97

64

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03

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No

.37

61

10 mg

Figure 5-5 Robitussin is the trade name of this drug which is a combination medication with two dosage strengths: dextromethorphan HBr 20 mg/10 mL and guaifenesin 200 mg/10 mL. The total vol-ume is 4 fl oz (118 mL).

Drug FactsActive ingredients (in each 10 ml)Dextromethorphan HBr, USP 20 mg .... Cough suppressantGuaifenesin, USP 200 mg ............... Expectorant

Uses • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

WarningsDo not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist beforetaking this product.Ask a doctor before use if you have • Cough that occurs with too much phlegm (mucus) • Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysemaStop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

ADULT

Robitussion®

PEAK COLDSUGAR-FREE

Cough+ChestCongestion DM

Relieves:• Cough • Mucus

SpeciallyFormulatedfor DIABETICS

Non-DrowsyFor Ages 12 & Over4 FL OZ (118 ml)DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

DMSUGAR-FREE

DYE-FREE

Figure 5-6 Desonide ointment’s net weight is 15 g, and its dosage strength is 0.05% (0.05 g/100 g).

DESONIDEOintment 0.05%

Rx ONLYFor External Use Only

Keep out of reach of children

15 gNDC 51672-1281-1

Not For Ophthalmic Use

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multiple-Dose and single-Dose packagingA multiple-dose, or multiple-use, package contains enough medication for more than one dose (Figure 5-7). Medications in multiple-dose containers have preservatives, if necessary, to ensure that each dose of medication is safe to administer as long as the storage instructions and expiration information on the label are followed.

single-dose/single-use containers hold enough medication for a typical single dose (Figure 5-8). If a single-use container holds more than the dose ordered, the excess medication must be discarded. This is necessary because the medication may not contain preservatives or the container may not retain the sterility that may be required for a subsequent dose. For example, it is not appropriate to save the unused tablet from a single-dose packet that originally contained two tablets. However, it is appropriate to save the remaining tablets in a multiple-use bottle, providing the tablet used was removed correctly (using aseptic technique).

route of administrationThe route, as mentioned in Chapter 3, is the bodily entry point for medication administration, leading to absorption into the bloodstream (Figure 5-9). Common routes include oral (PO), subcutaneous (subcut), intramuscular (IM), and intravenous (IV). Some other routes are ophthalmic (into the eye), otic (into the ear), nasal (into the nose), inhalation, topical, vaginal, rectal, intradermal (into the skin), and intraosse-ous (into the bone). The route may be listed as part of the name, such as “nasal spray,” or it may be listed separately, such as “for IM or IV” use. It is assumed that tablets and capsules are enteral medications, unless another route is specified on the label. Suppositories are labeled with a phrase indicating the rectal or vaginal route should be used. The topical route is used when creams, ointments, and patches are placed on the skin.

Figure 5-7 This multiple-dose vial of lidocaine HCl 2% may be used for more than one dose.

MULTIPLE-DOSE50 mL

Figure 5-8 Even if there are more doses left in the vial after the first dose is with-drawn, the remaining dose/s must be dis-carded as this single-dose vial of lidocaine HCl 1% may be used for only one dose.

Lidocaine HCLinjection, USP10 mg/mL

Preservative-Free

LOT 62-204-ON30 mL single-dose

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

LOT 62-204-ON EXP

1%

Clinical Clue

Although multiple-dose containers can be used multiple times, they should be used for the same patient. There is a risk for cross-contamination when one container of medication is used for multiple patients. When opening a multiple-dose vial, the nurse should apply a label indicating the patient’s name and the date and time when the vial was opened.


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The importance of identifying the intended route cannot be overstated. Nurses have made fatal errors by administering medications through the wrong route, such as administering an oral solution intrave-nously. It should not be assumed that a medication delivered in a syringe can be given IV or IM. The nurse must always read the label to determine the route.

reconstitution instructionsreconstitution is the process of reforming/transforming (changing the form of) a medication. Reconsti-tution instructions are mixing directions for liquefying a powdered (solid) medication (Figures 5-10 and 5-11). It is important to follow the manufacturer’s directions for reconstitution. More details on reconstitu-tion are provided in Chapter 9, “Parenteral Medication Dosage Calculations.”

Figure 5-9 Both of these labels are for furosemide liquid 10 mg/mL, but one is for parenteral administration (injection, for IV or IM use) and the other is for enteral administration (oral solution).

10 mL Single-dose

Injection, USP Rx only

For I.V. or I.M. use. Sterile,nonpyogenic. Do not use if solution is discolored or contains particulate. Contains no preservative.

PROTECT FROM LIGHT

NDC 0409-6102-04

RL-0205 Lot/

Exp

.

FUROSEMIDE

100 mg (10 mg/mL)

Oral Solution USP

Rx only

Lot:

Exp.:

NDC 0054-3294-50

Each mL contains 10 mgfurosemide.

SUGAR FREE

USUAL ADULT DOSAGE:See accompanying circular.

Store at 25˚C (77˚F); excursions permitted to15˚ to 30˚C (59˚ to 86˚F).[See USP Controlled RoomTemperature.]

PROTECT FROM LIGHT

120 mL

FUROSEMIDE

10 mg/mL

Figure 5-10 Dosage strength will be 1 mg/mL after the reconstitution instructions are followed.

VecuroniumBromide forInjection

For IV Use Only*1 mg/mL when mixed with 20 mL sterile water for injection

NDC 0069-0108-04

20 mg*

Rx only

Directions forreconstitution


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WarningsThe manufacturer may print warnings or alerts on the label to protect the patient from medication admin-istration errors (Figure 5-12). Examples include:

◾ “Not for injection”

◾ “Package not child resistant”

◾ “Not for lock flush”

◾ “Protect from light”

In addition, the pharmacist may attach warning labels, such as:

◾ “Shake well.”

◾ “Do not drink alcohol while taking this medication.”

It is important to read all of the warnings on the label. Heeding warnings may prevent an error.

Figure 5-12 Warning on sodium nitroprusside.

NDC 0409-3024-01

RL-2

267

(8/0

7)

Sodium Nitroprusside

WARNING

50 mg/mL Vial

2 mL Single-dose Fliptop Vial

(25 mg/mL)FOR I.V. INFUSION ONLY

Rx only

Monitor blood pressure before

and during administration.

PROTECT FROM LIGHT

Figure 5-11 Directions for mixing Augmentin oral suspension for PO administration.

AUGMENTIN

AUGMENTIN125 mg/5 mL

125 mg/5 mL

75 mL (when reconstituted)

Rx onlyGlaxoSmithKlinegsk 0 0 2 9 – 6 0 9 0 – 3 9N3 7

94

20

05

0–

A

LOT

EX

P

AMOXICILLIN/CLAVULANATE POTASSIUM

NDC 0029-6090-39

When reconstituted, each 5 mL contains:

Use only if inner seal is intact.Net contents:Equivalent to 1.875 gamoxicillin and0.469 g clavulanic acid.Store dry powder atroom temperature.

Directions for mixing:Tap bottle until all powder flowsfreely. Add approximately 2/3 oftotal water for reconstitution(total = 67 mL); shake vigorouslyto wet powder. Add remainingwater; again shake vigorously.Dosage: See accompanyingprescribing information.

Keep tightly closed.Shake well before using.Must be refrigerated.Discard after 10 days.

AMOXICILLIN, 125 MGas the trihydrateCLAVULANIC ACID, 31.25 MGas clavulanate potassium

FOR ORAL SUSPENSION

Directions forreconstitution

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Controlled substance scheduleA controlled substance is a drug whose manufacturing or possession is regulated by the federal gov-ernment. The government’s controlled substance schedule differentiates controlled substances into five categories (schedules) according to their potential for abuse or addiction (U.S. Drug Enforcement Administration, 2014):

◾ Schedule I—substances with the most potential for abuse or addiction with no medicinal benefit (e.g., heroin)

◾ Schedule II—medications with the most potential for abuse or addiction (e.g., OxyContin)

◾ Schedule III—medications with less abuse potential than Schedule I or II drugs, but whose abuse may lead to low to moderate physical dependence or high psychological dependence (e.g., Vicodin)

◾ Schedule IV—medications with lower abuse potential than Schedule III drugs (e.g., Valium)

◾ Schedule V—substances with the lowest potential for abuse or addiction, typically a combination medi-cation in which the addictive substance has a low dosage strength (e.g., Robitussin AC, which contains a small amount of codeine)

Controlled substances can be readily recognized by the large “C” that appears on the medication label. The schedule number (I–V) is inserted in the center of the “C” as shown in Figure 5-13.

Figure 5-13 Fentanyl is a controlled substance—a Schedule II medication.

FENTANYLTRANSDERMAL PATCH

NOT FOR ACUTE OR POSTOPERATIVE USE

In vivo delivery of 100 mcg/hr fentanyl for 72 hours

Each transdermal system contains:10.20 mg fentanylOne (100 mcg/hr) System

ATTENTION:

Only for u

se by

patient fo

r whom

presc

ribed.

100 mcg/hr

NDC 0378-9124-16

Rx only

Controlled Substance Schedule II

WarnIng! Do not Misinterpret Schedule for route

Use caution when interpreting the controlled substance schedule. Do not misinterpret Schedule IV for the intravenous (IV) route of administration.


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storage informationThe medication label will indicate the temperature range at which the medication should be stored. It also will provide other storage information if indicated, such as “protect from light” or “discard unused portion after 14 days” (Figure 5-14).

manufacturing informationThe U.S. Food and Drug Administration (FDA) requires the following manufacturing information to appear on every medication label (Figure 5-15):

◾ Pharmaceutical company—name of the company that manufactures the medication.

◾ national Drug Code (nDC)—a number that is a “universal product identifier for human drugs” (FDA, 2014). The NDC number is also called a control number. All medications and compounds that are manufactured for public distribution are registered with the FDA and given a three-part numeric code that is unique to the medication. The NDC Directory is maintained by the FDA. This directory lists product information by NDC number. The old version was based on data provided on paper; the new version is based on electronically submitted information. In 2012, the FDA began the process of merg-ing the information from the old NDC Directory into the new version. The NDC Directory is now up-dated daily.

Figure 5-14 The arrow is pointing to storage information on this becaplermin gel label.

NDC 0045-0810-15For Topical Use OnlyMultidose tube

Contains: becaplermin 0.01%, sodiumcarboxymethylcellulose, sodium chloride,sodium acetate trihydrate, glacial acetic acid,L-lysine hydrochloride, and water for injection,with preservatives: methylparaben 0.156%,propylparaben 01.017%, and m-cresol 0.086%.Dosage and Administration: See package insert.STORE REFRIGERATED, 2°–8°C (36°–46°F).DO NOT FREEZENET WT. 15g

Gel 0.01%

Rx only

Becaplermin

Figure 5-15 The manufacturer’s information (pharmaceutical company, NDC code, lot number and bar code) is printed or imprinted on the label.

THIS PRODUCT MUST BE SHAKENWELL ESPECIALLYPRIOR TO INITIAL USE.

Each 5 mL contains 125 mg phenytoin,with a maximum alcohol content notgreater than 0.6 percent.DOSAGE AND USEAdults, 1 teaspoonful (5 mL) three times daily;pediatric patients, see package insert.Advice to Pharmacist andPatient–Patient must be advised to use an accuratemeasuring device when using this product.See package insert for complete prescribing information.Store at Controlled Room Temperature 20°–25°C(68°–77°F) [see USP].Protect from freezing and light. Keep this and all drugs out of the reach of children.

ALWAYS DISPENSE WITH MEDICATION GUIDENDC 0071-2214-20

8 fl oz (237 mL)

Dilantin-125®

(PhenytoinOral Suspension, USP)

125 mg per 5 mL

7609

IMPORTANT-SHAKE WELL BEFORE EACH USE

NOT FOR PARENTERAL USE

Rx only

1172

5100

LOT

/ EX

P

Impr

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Are

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0071–2214–20N3 8

FPO:UPC 90% X .52"

Lot number andexpiration dateare imprinted here.

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◾ Expiration date—the date past which the medication should not be administered. The expiration date is either printed (with ink) or imprinted (with an impression) on the label.

◾ lot number—a number identifying the batch and manufacturing plant. This number (printed or imprinted on the label) tracks medications made in the same lot, enabling them to be recalled if a problem arises with the medication.

◾ Bar code—a code required by the U.S. Department of Health and Human Services on the label of all human medications and biological agents. It provides the ability to double-check a medication (e.g., the nurse reads the drug name and scans the code), an approach that has been demonstrated to re-duce medication errors. The bar code should never be used as the sole method of verifying the medica-tion. More information on bar code scanning is provided in Chapter 6, “Elements of Safe Medication Administration.”

LearnIng actIvIty 5-1 Refer to Figure 5-16 to answer the following questions.

1. What is the trade name?2. What is the generic name?3. What is the total number of capsules?4. What is the dosage strength?5. Can this capsule be opened?6. How long can this medication be stored after opening?7. What is the name of the manufacturer?

WarnIng!Store Medications per Label or Package Insert

Medications must be stored properly. Heat and moisture may damage medicines and make them less potent. Medications that require refrigeration must be stored at the proper temperature. Freezing temperatures will lead to inactivation of some medications, such as vaccines. Nurses can prevent medication errors related to improper storage by always inspecting a medication prior to administration, and by storing medications per the label or package insert instructions.

Figure 5-16 Pradaxa label.

Rx onlyBoehringerIngelheim

Pradaxa®

(dabigatran etexilate)Capsules

DISPENSE IN THIS UNIT OF USECONTAINER WITH ENCLOSEDMEDICATION GUIDE

75 mg*

Swallow capsule whole.

Once opened, the product mustbe used within 4 months.

60 capsules

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5-2 Information on a Medication Package Insert

In addition to the information listed on the medication label, the package insert provides detailed informa-tion for prescribing, storing, dispensing, and patient teaching. The package insert is designed to provide pre-scribers, pharmacists, and nurses with the information needed to order, store, dispense, prepare, advise, and administer the medication safely. The package insert was reformatted in 2006 by the FDA (2009) to include highlights of significant information, a table of contents, a toll-free number, and Internet reporting informa-tion for reporting suspected side effects (Figure 5-17).

Figure 5-17 Portion of Nasonex package insert using the revised format.

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use NASONEX safely and effectively. See full prescribing information for NASONEX.

NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg††calculated on the anhydrous basisInitial U.S. Approval: 1997

------------------ INDICATIONS AND USAGE ------------------------NASONEX is a corticosteroid indicated for:1. Treatment of Nasal Symptoms of Allergic Rhinitis in patients ≥2 years of age (1.1)2. Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis in patients ≥2 years of age (1.2)3. Prophylaxis of Seasonal Allergic Rhinitis in patients ≥12 years of age (1.3)4. Treatment of Nasal Polyps in patients ≥18 years of age (1.4)

---------------- DOSAGE AND ADMINISTRATION ------------------For Intranasal Use Only→ Treatment of Nasal Symptoms of Allergic Rhinitis (2.1) Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril once daily Children (2-11 yrs.): 1 spray in each nostril once daily→ Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis (2.2) Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril once daily Children (2-11 yrs.): 1 spray in each nostril once daily→ Prophylaxis of Seasonal Allergic Rhinitis (2.3) Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril once daily→ Treatment of Nasal Polyps (2.4)

Adults (18 yrs. and older): 2 sprays in each nostril twice daily. 2 sprays in each nostril once daily may also be effective in some patients.

--------------------- DOSAGE FORMS AND STRENGTHS --------------------Nasal Spray: 50 mcg of mometasone furoate in each 100-microliter spray (3)

------------------------------ CONTRAINDICATIONS -----------------------------Patients with known hypersensitivity to mometasone furoate or any of the ingredients of NASONEX. (4)

----------------------- WARNINGS AND PRECAUTIONS -----------------------→ Epistaxis, nasal ulceration, Candida albicans infection, nasalseptal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. (5.1)→ Development of glaucoma or cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. (5.2)→ Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. (5.4)→ Hypercorticism and adrenal suppression with higher than recommended dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue NASONEX Nasal Spray slowly. (5.5)→ Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving NASONEX Nasal Spray. (5.6, 8.4)

------------------------------ ADVERSE REACTIONS ----------------------------The most common adverse reactions (≥5%) included headache, viral infection, pharyngitis, epistaxis and cough. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877- 888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE 1.1 Treatment of Allergic Rhinitis 1.2 Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis 1.3 Prophylaxis of Seasonal Allergic Rhinitis 1.4 Treatment of Nasal Polyps2 DOSAGE AND ADMINISTRATION 2.1 Treatment of Allergic Rhinitis 2.2 Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis 2.3 Prophylaxis of Seasonal Allergic Rhinitis 2.4 Treatment of Nasal Polyps3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS 5.1 Local Nasal Effects 5.2 Glaucoma and Cataracts 5.3 Hypersensitivity Reactions 5.4 Immunosuppression 5.5 Hypothalamic-Pituitary-Adrenal Axis Effect 5.6 Effect on Growth6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Post-Marketing Experience7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment10 OVERDOSE

11 DESCRIPTION12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES 14.1 Allergic Rhinitis in Adults and Adolescents 14.2 Allergic Rhinitis in Pediatrics 14.3 Nasal Polyps in Adults 18 Years of Age and Older 14.4 Nasal Congestion Associated with Seasonal Allergic Rhinitis16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION 17.1 Local Nasal Effect 17.2 Glaucoma and Cataracts 17.3 Immunosuppression 17.4 Use Regularly for Best Effect

* Sections or subsections omitted from the full prescribing information are not listed.

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The typical components of a package insert include:

◾ Indications and usage—the medical conditions for which the preparation is intended and approved by the FDA to treat

◾ Dosage and administration—includes safe dosage range and intervals, dilution information (if required), route of administration, and rate of administration (if infused)

◾ Dosage forms and strengths—all of the available dosage forms and strengths, not just the enclosed form and strength as indicated on the label

◾ Contraindications—who and/or what conditions the medication should not be used to treat (e.g., people with allergies to the ingredients, people who have glaucoma, women who are nursing, or other reasons)

◾ Warnings and precautions—serious, possibly life-threatening conditions or reactions (side effects) that might occur if the medication is administered and how to administer or discontinue administering the medication if a reaction occurs

◾ Adverse reactions—less threatening reactions that have occurred during clinical trials (experiments con-ducted prior to FDA approval) or after marketing for use by the general public

◾ Drug interactions—reactions of two types can occur: ◾ Inside the body when a medication is administered while a different medication is still active in the

body, three types of reactions are possible: ◾ Increased potency of medication ◾ Decreased potency of medication ◾ New substance formation

◾ Outside of the body, if two medications come in contact while mixing or infusing in an IV, a new compound can form in the IV tubing, needle, or vial.

◾ Use in specific populations—reactions that occur within a specific group of patients, such as pregnant women, nursing mothers, children, the elderly, or patients with liver or kidney failure

◾ Overdosage—reactions/fatalities that have been observed after taking too much medication

◾ Description—chemical and physical description of the medication

◾ Clinical pharmacology ◾ Action—how the drug works in the body, such as “improves breathing by decreasing inflammation

in the airways” ◾ Pharmacodynamics—what the medication does on a cellular level, such as promoting or blocking a

process by occupying a receptor site to prevent transmission of chemical substance ◾ Pharmacokinetics—effect of the body on the medication, such as how it is absorbed, distributed,

metabolized, and excreted

◾ Nonclinical toxicology—reports on animal studies indicating gene mutation, cancerous growths, or infertility, and reports on the offspring of female animals that received the medication before and/or during pregnancy

◾ Clinical studies—controlled studies of the efficacy and safety of the medication when used to treat the conditions listed under Indications

Clinical Clue

If the package insert for a medication is not available, the nurse can view the package insert information online.

5-2 Information on a Medication Package Insert 127

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◾ How supplied/storage and handling—describes the medication container, the total amount within the container, and the total number of doses within the container; includes the NDC number and provides detailed storage information (Figure 5-18)

◾ Patient counseling information—information identifying risks, usage instructions for best effect, how to handle a missed dose, and how to self-administer the medication (if applicable)

Figure 5-18 How supplied/storage and handling section of Nasonex package insert.

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HOW SUPPLIED/STORAGE AND HANDLING

NASONEX (mometasone furoate monohydrate) Nasal Spray, 50 mcg, is supplied in a white, high-density, polyethylene bottle fitted with a white metered-dose, manual spray pump, and blue cap. It contains 17 g of product formulation, 120 sprays, each delivering 50 mcg of mometasone furoate per actuation. (NDC 0085-1288-01).

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light. When NASONEX Nasal Spray, 50 mcg, is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable.

SHAKE WELL BEFORE EACH USE.

Keep out of reach of children.

What’s on a label? … Case ClosureShould the student nurse administer the otic solution into the eye? The label, stating “ofloxacin otic solution,” not only contains the name of the medication but also indicates the route. The medication provided was the right drug, but the wrong route. The order called for ophthalmic (eye) drops, but the ofloxacin drops supplied were otic (ear) drops, so the student nurse should not administer this medication preparation. The correct preparation should have the following label:

OFLOXACIN

0.3% w/v5 mLSTERILE

OfloxacinOphthalmic Solution USP

ANTI

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L AG

ENT

Each

mL

cont

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oflox

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Apo-ofloxacin, ofloxacin ophthalmic solution (eye drops).


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learning Outcomes points to remember

5-1 Differentiate information on a medication label.

• Generic name: chemical name; does not identify the manufacturer; listed in United States Pharmacopeia—National Formulary (USP-NF)

• Trade/brand name: name specific to the manufacturer, registered with U.S. Department of Commerce

• Combination medication: lists the generic name of each medication and the dosage strength of each medication

• Form: identified on label: solid (capsule, tablet, gelcap, suppository), liquid (oral liquid, injectable liquid, inhalant, drop, spray, mist), or other (topical cream, ointment, patch)

• Dosage strength: amount of medication in each dosage unit (e.g., 325 mg per tablet, 80 mg per mL, 200 mcg per metered spray)

• Total number, volume, or net weight: total number of solid medication units (e.g., tablets), total volume of liquid or total weight of ointment or cream per container (e.g., bottle, tube)

• Multiple dose/multiple use: medication packaging containing more than one medication dose

• Single dose: medication packaging that contains one typical medication dose • Single use: medication container designed to be used once and then

discarded • Route of administration: bodily entry point for medication administration,

leading to absorption into the bloodstream; may be implied in the medica-tion name (e.g., “nasal spray” implies nasal inhalation)

• Reconstitution: process of mixing a medication (e.g., liquefying a powdered medication)

• Warnings: alerts on the label to protect the patient from medication adminis-tration errors

• Controlled substance schedule: classification of substances (Schedules I–V) that lead to physical or psychological dependence; ranges from Schedule I (most potential for abuse) to Schedule V (least potential for abuse); labeled with a “C” in which a Roman numeral schedule number is inserted in the center

• Storage information: temperature range, lighting, shelf life • Manufacturing information: pharmaceutical company, NDC/control number,

expiration date, lot number, bar code

5-2 Identify information on a medication package insert.

• The package insert is designed to provide prescribers, pharmacists, and nurses with the information needed to order, store, dispense, prepare, advise, and administer the medication safely.

• Highlights of prescriber information are included at the top of the insert, followed by reporting information for suspected reactions.

• A table of contents is given to provide for easy navigation through the pack-age insert.

• Some categories of information include indications and usage, dosage and administration, contraindications, precautions and warnings, adverse inter-actions, drug interactions, clinical studies, storage and handling, and patient counseling information.

Chapter Summary

Chapter Summary 129

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Homework

For exercises 1–10, indicate whether the statement is true or false. Correct false statements to make them true. (LO 5-1)

1. The United States Pharmacopeia—National Formulary (USP-NF) is a book that contains standards for medicines, dosage forms, drug sub-stances, excipients, medical devices, and dietary supplements.

2. The generic name is registered with the U.S. De-partment of Commerce, Patent and Trademark Office, by the manufacturer, so that no other phar-maceutical company can use the same name.

3. Dosage strength refers to the amount of medica-tion in the container.

4. Reconstitution instructions are directions for liq-uefying a powdered medication.

5. All medications have a controlled schedule number.

6. There are five schedules for controlled sub-stances; the first schedule is for highly addictive substances that have no medicinal benefit.

7. Only controlled schedule medications have a Roman numeral within the letter C on the medication label.

8. The package insert will provide more complete information about the drug than the label, in-cluding the chemical and physical description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, adverse reactions, overdosage, dosage and administra-tion, preparation for administration, and manu-facturer supply information.

9. The NDC number indicates the manufacturing batch, date, and location.

10. The route of administration may be indicated by the name of the medication.

For exercises 11–44, provide the information requested for each corresponding medication label that precedes it. (LO 5-1)

11. Generic name 12. Trade name 13. Total number of capsules 14. Dosage strength 15. Manufacturer

16. Generic name 17. Route of administration 18. Control schedule 19. Single-use or multiple-use vial 20. NDC number

22. Manufacturer 23. Route of administration 24. Dosage strength

21. To which conditions are neonates vulner-able when this medication is administered too rapidly?

Cardizem®(diltiazem HCI)

180 mg30 Capsules

NDC 0187-0796-42

Pharmaceuticals International

CD

CEFPROZILfor Oral Suspension USP

NDC 0093-1075-78

125 mg/5 mL**Each 5 mL, when constituted according to

directions, contains 125 mg anhydrous cefprozil.

Rx only

333-32-100287Rev. A 7/2005

75 mL (when mixed)

N 39

0093

–107

5–78

To the Pharmacist: prepare suspension at time of dispensing. Add to the bottle a total of 59 mL water. For ease in preparation, add the water in two portions. Shake well after each addition. This provides 75 mL of suspension. Each 5 mL contains cefprozil equivalent to 125 mg anhydrous cefprozil.Usual Dosage: See package insert for full prescribing information. Store powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] prior to constitution.Store constituted suspension in refrigerator. Discard after 14 days.Phenylketonurics: This product contains 10.1 mg of phenylalanine per 5 mL (approx. one teaspoonful) of suspension.SHAKE WELL BEFORE USING.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

WARNING

Adult and Pediatric: Intravenous midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy has resulted.

Neonates: Midazolam should not be administered by rapid injection in the neonatal population. Severe hypotension and seizures have been reported following rapid IV administration, particularly with concomitant use of fentanyl (see DOSAGE AND ADMINISTRATION for complete information).

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25. Total volume after mixing 26. Trade name 27. NDC or Bar Code Number

39. Generic name 40. Net weight 41. Dosage strength

28. Trade name 29. Total volume 30. Dosage strength 31. Manufacturer 32. Where can you find the full prescribing

information?33. Is the number under the bar code the same as the

NDC number?

34. Trade name 35. Is this a combination medication? If so, name the

medications. 36. How many units are in 1 mL? 37. Total volume 38. Route of administration

42. Route of administration 43. Can this medication be used in the eyes?

Label 2

44. Which label represents the medication form that should be used for the following order? “Diphen-hydramine 25 mg PO q6h”

For questions 45–50, select the category (a–j) on the package insert where the requested information can be located. (LO 5-2)

a. Indications and Usage/Use in Specific Populations

b. Dosage and Administrationc. Forms and Dosage Strengthd. Contraindicationse. Precautions and Warningsf. Adverse Reactionsg. Drug Interactionsh. Clinical Studiesi. Storage and Handlingj. Patient Counseling Information

45. Is the ordered dose safe to administer?46. Is this medication safe to administer if the pa-

tient also has asthma?

Label 1

A04890500

Delivers 5 mLNDC 0121-0489-05

DIPHENHYDRAMINE HCIORAL SOLUTION USP

12.5 mg/5 mL Alcohol 14%

FOR INSTITUTIONAL USE ONLYStore at 20° to 25°C (68° to 77°F).

[See USP Controlled RoomTemperature].

(01)

0

030

1210

48

905

1

Rx ONLYSEE INSERT

NDC 49769-105-01

ACTIVE INGREDIENTS: Lidocaine HCl 3%INACTIVE INGREDIENTS: Purified Water, WhitePetrolatum USP, Sorbitan Monostearate, MethylparabenNF, Propylparaben NF, Sodium Hydroxide NF, AluminumSulfate and Calcium Acetate.DOSAGE AND ADMINISTRATION: See package insert.Store at controlled room temperature, 20°–25°C (68°F–77°F). Protect from freezing. NET WT. 1 oz (28.3g)

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.Topical Anesthetic

Rx only

Lidocaine HCl 3% Cream

Exp. D

ate/Control N

o.W

G 4180 A

MX 75% insulin lispro protamin

suspension, 25% insulin lisproinjection (rDNA origin)

Rx only U-100

For s

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75/25®

Jones &Bartlett

NDC 0002-7511-01VL-751110 mL

100 units per mL

33

0002

-751

1-01

Lispro InsulinMix

DiphenhydrAMINEHYDROCHLORIDEINJECTION, USP

HIGH POTENCYFor IM or IV Use

50 mg/5 mL

NDC 63223-664-01

1 mL in a 2 mLSingle Dose Vial

Rx only

THIS PRODUCT MUST BE SHAKENWELL ESPECIALLYPRIOR TO INITIAL USE.

Each 5 mL contains 125 mg phenytoin,with a maximum alcohol content notgreater than 0.6 percent.DOSAGE AND USEAdults, 1 teaspoonful (5 mL) three times daily;pediatric patients, see package insert.Advice to Pharmacist andPatient–Patient must be advised to use an accuratemeasuring device when using this product.See package insert for complete prescribing information.Store at Controlled Room Temperature 20°–25°C(68°–77°F) [see USP].Protect from freezing and light. Keep this and all drugs out of the reach of children.

ALWAYS DISPENSE WITH MEDICATION GUIDENDC 0071-2214-20

8 � oz (237 mL)

Dilantin-125®

(PhenytoinOral suspension, USP)

125 mg per 5 mL

7609

IMPORTANT-SHAKE WELL BEFORE EACH USE

NOT FOR PARENTERAL USE

Rx only

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Homework 131

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47. Are there any increased risks if an elderly person takes this medication?

48. What should the nurse tell the patient about this medication?

49. Can this medication be administered if the pa-tient is also taking iron?

50. Is this medication available in liquid form if the patient cannot swallow pills?

NCLEX®-Style Review Questions

For questions 1–4, select the best response.1. The prescriber orders phenytoin 250 mg PO qid for

1 day. Which preparation should the nurse use?a. Phenytoin oral suspension 100 mg in a 4 mL

single-dose containerb. Phenytoin oral suspension 125 mg/5 mL in a 240

mL multiple-dose containerc. Phenytoin ER 100 mg/capsule in a 180-capsule

containerd. Phenytoin injection 250 mg/5 mL in a 5 mL

single-dose container2. The medication label states: “Protect from light. Store

between 36° and 46°F (20–25°C).” The nurse should:a. Place the medication in a zip-lock bag and store

it at room temperature.b. Wrap the medication in foil and store it at room

temperature.c. Place the medication in a paper bag and store it

in the refrigerator.d. Wrap the vial in foil and store it in the freezer.

3. The prescriber orders diazepam 5 mg PO, single dose, now. Which preparation should the nurse use?a. Diazepam inj 5 mg/mL single-dose containerb. Diazepam oral solution 2 mg/5 mL single-dose

containerc. Diazepam 2 mg/tablet single-dose containerd. Diazepam 5 mg/tablet multiple-dose container

4. The prescriber orders furosemide 10 mg IV bid. The nurse is supplied with furosemide with the following label. The nurse should:

a. Call the pharmacist to deliver a different preparation.

b. Administer the contents and protect the unused portion from light.

c. Administer the contents of the vial and then dis-card the vial.

d. Administer half of the contents and discard the remainder.

For questions 5 and 6, refer to the labels associated with the question and identify all information that can be found on the label. Select all that apply.

5.

a. The dosage strength is 2 mg/g.b. Requires a prescription.c. To be applied in the eye.d. Keep out of reach of children.e. Net weight 20 g.

6.

a. Store at room temperature.b. May be administered subcut.c. Protect from light.d. Vial contains two 10 mL doses.e. Solution should be clear.

reFerenCesMedlinePlus. (2018, January 14). Storing your medicines.

Retrieved from https://medlineplus.gov/ency /patientinstructions/000534.htm

U.S. Drug Enforcement Administration. (2014). Controlled substance schedules. Retrieved from http://www.deadiversion.usdoj.gov/schedules /GuidanceComplianceRegulatoryInformation /LawsActsandRules/ucm188665.htm

U.S. Food and Drug Administration (FDA). (2014). National Drug Code Directory: Background informa-tion. Retrieved from http://www.fda.gov /Drugs/InformationOnDrugs/ucm142438.htm

Hydrocortisone ValerateCREAM USP, 0.2%

Rx ONLYFor Dermatological Use Only

Keep out of reach of children

45 gNDC 51672-1290-6

Not For Ophthalmic Use

NDC 0409-6102-04

RL-1881 (9/06)

Lot

Exp

.

FUROSEMIDE

20 mg (10 mg/mL)

2 mL Single-dose

Injection, USP

Rx only

For I.V. or I.M. use.Do not use if solution is discolored or contains particulate.

NDC 0517-5702-25

FUROSEMIDE

20 mg/2 mL

2 mL SINGLE DOSE VIALFOR I.V. OR I.M. USE

INJECTION, USP

(10 mg/mL)

Rx only

WARNING: USE ONLY IF SOLUTION IS CLEAR AND COLORLESS. PROTECT FROM LIGHT. Store at 20˚ to 25˚C (68˚ to 77˚F) (See USP Controlled Room Temperature)Directions for Use:See Package Insert

Lot:

Exp.

:


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United States Pharmacopeia—National Formulary (USP-NF). (2014). USP-NF: An overview. Retrieved from http://www.usp.org/usp-nf

Chapter 5 ansWer Key

learning activity 5-11. Pradaxa2. dabigatran etexilate3. 60 capsules per bottle4. 75 mg per capsule5. No, it must be swallowed whole.6. 4 months7. Boehringer Ingelheim

Homework

1. True2. False. The trade name is registered with the U.S. De-

partment of Commerce, Patent and Trademark Office, by the manufacturer, so that no other pharmaceutical company can use the same name.

3. False. Dosage strength refers to the amount of medica-tion per dosage unit.

4. True5. False. Medications that are prone to physical or

psychological abuse or dependence have a controlled schedule number.

6. True7. True8. True9. False. The lot number indicates the manufacturing

batch, date, and location.10. True11. diltiazem HCl12. Cardizem CD13. 30 capsules14. 180 mg/capsule15. Valeant Pharmaceuticals International16. midazolam 17. IM/IV18. Schedule IV19. Multiple-use; benzyl alcohol is a preservative20. NDC 10019-028-0121. Severe hypotension and seizures22. Teva Pharmaceuticals USA23. PO (oral; by mouth)

24. 125 mg/5 mL25. 75 mL26. There is no trade name. There is only a generic name,

cefprozil.27. 0093-1075-7828. Dilantin-12529. 8 fl oz or 237 mL30. 125 mg/5 mL31. Pfizer32. In the package insert33. Yes34. Lispro Insulin Mix 75/2535. Yes, insulin lispro protamine suspension and insulin

lispro injection36. 100 units37. 10 mL38. Subcut39. Lidocaine HCl40. 1 oz (28.3 g)41. 3% or 3 g per 100 g42. Topical43. No, it is not for ophthalmic use.44. Label 245. b (Dosage and administration)46. d (Contraindications)47. a (Use in specific populations)48. j (Patient counseling information)49. g (Drug interactions)50. c (Forms and dosage strengths)

NCLEX-Style Review Questions

1. brationale: Phenytoin oral suspension 125 mg/5 mL in a multiple-dose container will provide enough medication for the ordered dose (250 mg is twice 125, so 10 mL could be obtained from the multiple-dose container).

2. crationale: 36–46°F is a refrigerated temperature; 32°F and lower is freezing. Placing the medication in a paper bag will protect it from light.

3. drationale: In general, unless the patient has difficulty swallowing pills, tablets are used for oral doses rather than liquids. Single doses can be removed from multi-ple-dose containers, but a medication packaged as a single dose cannot be used for multiple doses.

Answer Key 133

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4. drationale: The single-dose vial contains twice the dose required. Although 20 mg will be given over the course of the day, medication in a single-dose vial can-not be saved for subsequent doses. The nurse should discard the vial with the remaining medication after removing 10 mg of furosemide.

5. a, b, drationale: The label information includes:a. USP, 0.2% indicates 0.2 g/100 g which equals

200 mg/100 g or 2 mg/g.b. “Rx ONLY” means a prescription is required.c. For Dermatological Use Only; Not for Ophthalmic Used. Keep out of reach of children.e. Net weight 45 g

6. a, c, erationale: The label states:a. Store between 68° and 77°F.b. For intravenous or intramuscular use.c. Protect from light.d. Discard unused portion; single-use vial.e. Use only if solution is clear and colorless.


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Chapter 5 - JBLearning

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