Chapter 6: Drug Labels and Package Inserts Math and Dosage Calculations for Health Care Third Edition Booth & Whaley Chapter 6: Drug Labels and Package Inserts McGraw-Hill

Learning Outcomes 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 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.

Introduction The drug label and package inserts contain information needed to perform dosage calculations. Read the label carefully.

Locating Information Drug name Form of the drug Dosage strength Total amount in the container Warnings Route of administration Storage requirements Manufacturing information

Drug Name Generic Name Official name Must appear on label Levothyroxine Sodium (generic name) Generic Name Official name Must appear on label National listings United States Pharmacopeia (USP) National Formulary (NF)

Synthroid (trade name) Drug Name (cont.) Synthroid (trade name) Trade Name Brand name Used to market the drug Property of drug company Registered mark ® - name registered with the U.S. Patent and Trademark Office Drug may be manufactured by more than one company.

Drug Name (cont.) Rule 6-1 Example Vicodin® is a narcotic painkiller You must know both the generic and trade names of drugs. Example Vicodin® is a narcotic painkiller Generic name: hydrocodone bitartrate and acetaminophen Other trade names: Anexsia®, Lortab®, Zydone®

Form of the Drugs Solid oral medications Liquids Other Tablets, capsules, gelcaps, caplets Liquids Oral, injections, inhalants, drops, sprays, mists Other Ointments, creams, lotions, patches, suppositories, shampoos

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.

Dosage Strength (cont.) Solid medications Dosage strength is the amount of drug present per tablet, capsule, or other form. Dosage strength 10 mg/1 tab

Dosage Strength (cont.) Liquid medications Dosage 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.

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.

Total Number or Volume in Container Many meds are packaged in unit doses One tablet / section of package Vial with 2 mL of solution for injection Multiple-dose containers Prescription medications Non-prescription medications

Total Number or Volume in Container (cont.) 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.

Route of Administration Directions for route of administration may be on the label. Tablets, capsules, gelcaps, caplets Swallow Sublingual Chewable Liquid medications Oral Injections Inhalants Topical / transdermal

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.

Warnings Help to administer drugs safely Types of warnings For specific groups, i.e. children, elderly For controlled substances About combining with other drugs or products Proper disposal following facility guidelines

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

Manufacturing Information Labels Regulated by the U.S. Food and Drug Administration (FDA) Must include: Name of the manufacturer Expiration date Lot number When and where a drug was produced Trace problems

Manufacturing Information (cont.) Rule 6 - 3 Never use a drug after the expiration date has passed. Older drugs may become chemically unstable or altered. Incorrect dose Effect different than intended one Educate patients to check expiration dates.

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 diluent Solution strength once reconstituted Time period for safe administration

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.

Package Inserts Complete and authoritative information about a medication Sections Description – chemical and physical Clinical Pharmacology – actions of the drug Indications and Usage

Package Inserts (cont.) Contraindications Warnings – serious side effects Precautions Adverse Reactions – anticipated side effects

Package Inserts (cont.) Overdosage – effects and instruction for treatment Dosage and Administration Preparation for Administration Manufacturer Supply – dosage strength and form availability

Practice What is the generic name of the drug? Answer celecoxib What is the dosage strength? Answer 50 mg capsules How should this drug be stored? Answer At 25°C (77°F) excursions permitted to 15-30°C (59-86°F)

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

Oral Drugs (cont.) Rule 6 - 4 Tablets may be broken to give a partial dose only when the tablets are scored. Never crush or break Enteric-coated medications Controlled-release medications (CR) Extended-release medications (ER or XL) Sustained-release medications (SR)

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

Oral Drugs (cont.) Rule 6 - 5 When reconstituting a drug, you must write your initials and the time and date of reconstitution on the label. shf 7/21/08 @ 1400

Practice What is the trade name of the drug? Answer Zetia® What is the usual dosage? Answer 1 tablet daily 10 mg/tablets What is the dosage strength?

Parenteral Drugs Packaged as Small containers have small labels Single-use ampules or vials Single-use prefilled syringes Multi-use vials Small containers have small labels Difficult to read Review package insert

Parenteral Drugs (cont.) Routes Intradermally (ID) Intramuscularly (IM) Intravenously (IV) Subcutaneously (Sub-q) Inhalants Transdermal Delivery

Parenteral Drugs (cont.) Dosage strength is the amount of drug per dosage unit Examples mg / tablet mg / mL mEq / mL units / mL gm / mL gm / tablet

Practice What is the dosage strength of the drug? Answer 20 mg/2 mL What is the drug’s name? Answer Furosemide What is the route of administration? Answer IM or IV

Drugs Administered by Other Routes Sublingual (under the tongue) Buccal (between the tongue and cheek) Rectal Vaginal Topical Eye or Ear drops Transdermal Inhalants

Drugs Administered by Other Routes (cont.) Dosage strength varies with type of drug and how it is administered Examples Transdermal – 0.2 mg/hr (the amount absorbed over time through the skin) Inhalent – 84 mcg / metered spray

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

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. F This would allow the drug to be absorbed sooner than intended. F Some capsules should be swallowed whole. T

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.

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

End of Chapter 6 Read in order to live. -Henry Fielding