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Math and Dosage Calculations for Health

Care Third EditionBooth & Whaley

Chapter 6: Drug Labels and Package Inserts

McGraw-Hill

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6.1 Identify on a drug label the drug name, form, dosage strength, route, warnings, and manufacturing and storage information.

6.2 Locate directions on drug labels and package inserts for reconstituting and diluting medications.

Learning Outcomes

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Learning Outcomes

6.3 Recognize different types of tablets and capsules.

6.4 Distinguish administration routes for medications.

6.5 Locate additional information in a package insert.

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Introduction

The drug label and package inserts contain information needed to perform dosage calculations.

Read the label carefully.

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Locating Information

Drug name

Form of the drug

Dosage strength

Total amount in the container

Warnings

Route of administration

Storage requirements

Manufacturing information

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Drug Name

Generic NameOfficial name

Must appear on label

National listings United States Pharmacopeia (USP)

National Formulary (NF)

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Levothyroxine Sodium (generic name)

Levothyroxine Sodium (generic name)

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Drug Name (cont.)

Trade NameBrand nameUsed to market the drugProperty of drug company

Registered mark ® - name registered with the U.S. Patent and Trademark Office

Drug may be manufactured by more than one company.

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Synthroid (trade name)

Synthroid (trade name)

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Drug Name (cont.)

Rule 6-1 Rule 6-1 You must know both the generic and trade

names of drugs.

ExampleExample

Vicodin® is a narcotic painkiller

Generic name: hydrocodone bitartrate and acetaminophen

Other trade names: Anexsia®, Lortab®, Zydone®

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Form of the Drugs

Solid oral medicationsTablets, capsules, gelcaps, caplets

LiquidsOral, injections, inhalants, drops, sprays,

mists

OtherOintments, creams, lotions, patches,

suppositories, shampoos

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Dosage Strength

Labels include information about the amount of drug present.

The amount of drug present per dosage unit combined with information about the form identifies the drug’s dosage strength.

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Dosage Strength (cont.)

Solid medicationsDosage strength is the amount of drug

present per tablet, capsule, or other form.

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Dosage strength10 mg/1 tab

Dosage strength10 mg/1 tab

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Dosage Strength (cont.)

Liquid medicationsDosage strength is the amount of drug present

in a quantity of solution.

Amount of solution varies per dosage unit.

Pharmaceutical companies manufacture meds with dosage strengths that match commonly prescribed doses.

Reduces the risk of error when calculating dosages.

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Combination Drugs

If available, the trade name may be used to order combination drugs.

Generic names and dosage strengths of all components must appear on the label.

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Total Number or Volume in Container

Many meds are packaged in unit dosesOne tablet / section of packageVial with 2 mL of solution for injection

Multiple-dose containersPrescription medicationsNon-prescription medications

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Total Number or Volume in Container(cont.)

Rule 6-2 Rule 6-2

Do not confuse the total amount of drug in the container with the dosage strength.

The container may hold 100 tablets and each tablet has a dosage strength of 2.5 mg per tablet.

The container may hold 100 tablets and each tablet has a dosage strength of 2.5 mg per tablet.

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Route of Administration

Liquid medications• Oral • Injections

InhalantsTopical / transdermal

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Directions for route of administration may be on the label.Tablets, capsules, gelcaps, caplets

• Swallow• Sublingual• Chewable

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Error Alert!

Give the right medication by the right route.

Do not administer drugs by any route other than described in the drug label or on the order.

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Warnings

Help to administer drugs safely

Types of warningsFor specific groups, i.e. children, elderly

For controlled substances

About combining with other drugs or products

Proper disposal following facility guidelines

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Storage Information

Maintain the drug’s potency and effectiveness

Information on label Storage temperature Exposure to light Length of time drug will remain potent after

container has been opened

Improper storage can trigger a chemical reaction and make the drug unusable

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Manufacturing Information

Labels Regulated by the U.S. Food and Drug

Administration (FDA) Must include:

Name of the manufacturerExpiration dateLot number

When and where a drug was produced Trace problems

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Manufacturing Information (cont.)

Rule 6 - 3Rule 6 - 3 Never use a drug after the expiration date

has passed.

Older drugs may become chemically unstable or altered.

Incorrect doseEffect different than intended one

Educate patients to check expiration dates.

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Information About Reconstituting Drugs

Powder forms must be reconstituted and other drugs require dilution prior to use.

Directions for reconstituting or diluting are on the label.Type and amount of diluentSolution strength once reconstitutedTime period for safe administration

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Error Alert!

Consider the age and health needs of the patient when administering a drug.

If another form of a drug is better suited to a patient’s needs, consult the physician or pharmacist about changing the order.

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Package Inserts

Complete and authoritative information about a medication

Sections

Description – chemical and physical

Clinical Pharmacology – actions of the drug

Indications and Usage

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Package Inserts (cont.)

Contraindications

Warnings – serious side effects

Precautions

Adverse Reactions – anticipated side effects

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Package Inserts (cont.)

Overdosage – effects and instruction for treatment

Dosage and Administration

Preparation for Administration

Manufacturer Supply – dosage strength and form availability

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Practice

What is the generic name of the drug?

Answer At 25°C (77°F) excursions permitted to 15-30°C (59-86°F)

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Answer 50 mg capsules

What is the dosage strength?

How should this drug be stored?

Answer celecoxib

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Oral Drugs

Solid or liquid forms

Tablets Scored – can be broken into equal portions Chewable – should be chewed to be effective Enteric-coated – must be swallowed whole Capsules

Some should be swallowed whole Others may be opened and mixed with food

Controlled-release – usually swallowed whole

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Oral Drugs (cont.)

Rule 6 - 4 Rule 6 - 4

Tablets may be broken to give a partial dose only when the tablets are scored.

Never crush or break Enteric-coated medicationsControlled-release medications (CR)Extended-release medications (ER or XL)Sustained-release medications (SR)

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Oral Drugs (cont.)

Liquids

Oral solutions

Syrups

Elixirs

Oral suspensions

Simple liquids

Dosage strength corresponds to a specific volume of the solution –

500 mg / 10 mL

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Oral Drugs (cont.)

Rule 6 - 5Rule 6 - 5

When reconstituting a drug, you must write your initials and the time and date of reconstitution on the label.

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shf 7/21/08 @ 1400

shf 7/21/08 @ 1400

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Practice

Answer Zetia®

Answer 1 tablet daily

What is the trade name of the drug?

What is the usual dosage?

What is the dosage strength?

10 mg/tablets

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Parenteral Drugs

Packaged asSingle-use ampules or vialsSingle-use prefilled syringesMulti-use vials

Small containers have small labelsDifficult to readReview package insert

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Parenteral Drugs (cont.)

RoutesIntradermally (ID)Intramuscularly (IM)Intravenously (IV)Subcutaneously (Sub-q)InhalantsTransdermal Delivery

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Parenteral Drugs (cont.)

Dosage strength is the amount of drug per dosage unitExamples

mg / tablet

mg / mL

mEq / mL

units / mL

gm / mL

gm / tablet

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Practice

Answer 20 mg/2 mL

Answer Furosemide

What is the dosage strength of the drug?

What is the drug’s name?

What is the route of administration?Answer IM or IV

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Drugs Administered by Other Routes

Sublingual (under the tongue)

Buccal (between the tongue and cheek)

Rectal

Vaginal

Topical

Eye or Ear drops

Transdermal

Inhalants

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Drugs Administered by Other Routes (cont.)

Dosage strength varies with type of drug and how it is administeredExamples

Transdermal – 0.2 mg/hr (the amount absorbed over time through the skin)

Inhalent – 84 mcg / metered spray

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Apply Your Knowledge

1. What is another name for the brand name?

2. What is the official name of a drug?

Answer trade name

Answer generic name

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Apply Your Knowledge

True or False

Enteric-coated tablets can be crushed and

mixed with food.

All capsules may be opened and mixed with food.

Parenteral forms of drugs includes transdermal and inhalants.

T

F

F

This would allow the drug to be absorbed sooner than intended.

Some capsules should be swallowed whole.

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Apply Your Knowledge

True or False (cont.)

The warnings section of a package insert lists the more serious, possibly fatal, side effects of a drug.

You may administer a drug after the expiration date has expired if you do not have any new ones.

T

F

It may not provide correct dosage strength or have an effect different than intended.

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Apply Your Knowledge

True or False (cont.)

You can use as much solution as you need to reconstitute a powdered medication.

The amount of drug in a container is not the same as the dosage strength.

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F

You must follow the directions for reconstituting a drug that are on the label or in the package insert.

T

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End of Chapter 6

Read in order to

live.

-Henry Fielding