McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved Math for the Pharmacy Technician: Concepts and Calculations Chapter 5: Drug Labels, Package Inserts, and References Egler Booth

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-2 Drug Labels and Package Inserts

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-3 Learning Objectives  Identify on a drug label the drug name, form, dosage strength, route, warnings, and manufacturing and storage information.  Locate directions on drug labels and package inserts for reconstituting and diluting medications. When you have successfully completed Chapter 5, you will have mastered skills to be able to:

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-4 Learning Objectives (con’t)  Recognize different types of tablets and capsules.  Distinguish administration routes for medications.  Locate additional information in a package insert.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-5 Introduction  Now that you have learned basic math, equipment, and drug orders, it is time to learn about drugs.  The drug label and package inserts contain information that you need to perform dosage calculations.  Be sure you know exactly what is on the drug label.  Be sure to read the fine print.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-6 Locating Information on Drug Labels and Package Inserts  Drug name  Form of the drug  Dosage strength  Total amount in the container  Warnings  Route of administration  Storage requirements  Manufacturing information

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-7 Drug Name Generic name = official name  By law this name must appear on the label. Levothyroxine Sodium = Synthroid (generic name) (trade name) Trade name = brand name used to market the drug

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-8 Drug Name (con’t)  Registered mark ® -- indicates the name has been legally registered with the U.S. Patent and Trademark Office.  Several companies may manufacture the same drug and market it under different trade names.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-9 Drug Name (con’t)  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 ®

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-10 Form of the Drugs  Solid oral medications  tablets, capsules, gelcaps, caplets  Liquids  oral, injections, inhalants, drops, sprays, mists  Other  ointments, creams, lotions, patches, suppositories, shampoos

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-11 Dosage Strength  Drug labels include information about the amount of drug present.  This amount combined with information about the form, identifies the drug’s dosage strength. Note: Dosage strength is stated as amount of drug per dosage unit. Grams (g), milligrams (mg), micrograms (mcg), or grains (gr) or Units

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-12 Dosage Strength (con’t) Solid medications  Dosage strength is the amount of drug present per tablet, capsule, or other form

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-13 Dosage Strength (con’t) Liquid medications  Dosage strength is the amount of drug present in certain quantity of solution  You need to know both the amount of drug and the amount of total solution  Amount of solution varies per dosage unit  Pharmaceutical companies manufacture meds with dosage strengths that match commonly prescribed drugs

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-14 Combination Drugs  Generic names and dosage strengths of all components of a combination drug must appear on the label.  All combination drugs have a trade name that is usually used in drug orders. Lortab ® 5/500 1 tab q 4-6 h PRN for pain (Lortab ® contains 5 mg hydrocodone bitartrate and 500 mg acetaminophen)

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-15 Total Number or Volume in Container Many oral meds are packaged in unit doses  a single tablet  vial with 2 mL of solution for injection Multiple-dose containers  one container with 50 gelcaps Nonprescription medication  often packaged in multiple-dose containers

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-16 Total Number or Volume in Container (con’t) 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.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-17 Route of Administration  Directions for the route of administration may be specified on the label.  If a tablet or capsule is not swallowed, additional information will be provided.  Label will indicate injection route.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-18 Route of Administration (con’t)  Tablets/Capsules  orally  sublingually  chewable  Liquids  orally  injection

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-19 CAUTION!  Give the right medication by the right route.  Do not administer drugs by any route other than intended, as described in the drug label or on the order.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-20 Warnings  Help to administer drugs safely  “May be habit forming.”  “Not safe for pregnant women or children.”  “Keep under close observation of a physician.”  Disposal of drugs  Follow guidelines of facility.  For example, flush narcotics with a coworker as witness, then appropriately document.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-21 Storage Information  To maintain the drug’s potency and effectiveness  Information will appear on label  storage temperature  exposure to light  length of time drug will remain potent after container has been opened Storage at the wrong temperature or exposure to light can trigger a chemical reaction and make the drug unusable.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-22 Manufacturing Information  Labels are regulated by the U.S. Food and Drug Administration (FDA) and must include:  Name of the manufacturer  Expiration date ∙ abbreviated EXP, after which the drug may no longer be used  Lot number ∙ indicates when and where a drug was produced ∙ allows manufacturer to trace problems

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-23 Manufacturing Information (con’t)  Never use a drug after the expiration date has passed.  Older drugs may become chemically unstable or altered.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-24 Information About Reconstituting Drugs  Powder forms of drugs must be reconstituted by adding a liquid for administration before you can give the drug.  Directions for reconstituting are on the label.  Label indicates the time period within which they can be safely administered.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-25 CAUTION! Consider the age and health needs of your patient when you administer a drug. If you see a situation where another form of a drug may work better, consult the physician or pharmacist about changing the form of the drug.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-26 Package Inserts Provide complete and authoritative information about a medication:  Description -- chemical and physical description of the drug  Clinical Pharmacology -- actions of the drug  Indications and Usage  Contraindications

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-27 Package Inserts (con’t)  Warnings  Precautions  Adverse Reactions  Overdosage  Dosage and Administration  Preparation for Administration  Manufacturer Supply

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-28 Review and Practice Biaxin® 500 mg tablets What is the generic name of the drug? What is the dosage strength? How should this drug be stored? between 20-25°C (68-77°F)

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-29 Oral Drugs Oral medications are available either in solid or liquids  Tablets  Scored -- can be broken into equal portions  Chewable -- must be chewed to be effective  Enteric-coated -- must be swallowed whole  Capsules ∙ should be swallowed whole ∙ may be opened and mixed with food  Sustained-release -- must be swallowed whole

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-30 Oral Drugs (con’t)  You may break tablets to give a partial dose only when the tablets are scored.  Enteric-coated, controlled-release, extended-release, and sustained- release medications should never be crushed or broken.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-31 Oral Drugs (con’t) Abbreviations such as SR, CR, and ER listed after the drug name indicates a special drug action  SR = sustained release  CR = controlled release  ER = extended-release

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-32 Oral Drugs (con’t) Liquids  Oral Solutions  Syrups  Elixirs  Oral Suspension  Simply Liquids

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-33 Oral Drugs (con’t)  When you reconstitute a drug, you must write your initials as well as the time and date of reconstitution on the label.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-34 Review and Practice Lexapro® Orally What is the trade name of the drug? How should this medication be administered? What is the dosage strength? 10 mg/tablet

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-35 Parenteral Drugs  Packaged as  Single-use ampules or vials  Single-use prefilled syringes  Multi-use vials  Small containers have small labels  Difficult to read  Often need to review package insert

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-36 Parenteral Drugs (con’t)  Routes  Intradermally (ID)  Intramuscularly (IM)  Intravenously (IV)  Subcutaneously (Sub-Q)  Inhalants  Transdermal delivery

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-37 Parenteral Drugs (con’t)  Dosage strength expressed as  ratio  mg or mcg  units  percent  mEq

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-38 Review and Practice 0.2 mg/mL Furosemide What is the dosage strength of the drug? What is the drug’s name? What is the route of administration? IM or IV

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-39 Drugs Administered by Other Routes  Sublingually (under the tongue)  Buccally (between the tongue and cheek)  Rectally  Vaginally  Topical  Eye or Ear drops  Transdermal  Inhalants

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-40 Drugs Administered by Other Routes (con’t)  Dosage Strength  Varies according to medication Examples  may be written as 0.2 mg/hr (absorbed over time through the skin)  or 84 mcg (dosage per metered spray)

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-41 Review and Practice What is another name for the brand name? Answer: trade name Answer: generic name What is the official name of a drug?

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-42 Review and Practice True or False  Enteric-coated tablets can be crushed and mixed with food. Answer: False Answer: True  Capsules may be opened and mixed with food.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-43 Review and Practice True or False  You may administer a drug after the expiration date has expired if you do not have any new ones. Answer: False  You can use as much solution as you need to reconstitute a powdered medication.

McGraw-Hill ©2010 by the McGraw-Hill Companies, Inc All Rights Reserved 5-44 Drug Labels and Package Inserts Make sure you know exactly what is found on a drug label, and do not forget to read the fine print. THE END