Y khoa - Dược - Chapter 5: Drug labels, package inserts, and references

Math for the Pharmacy Technician: Concepts and CalculationsChapter 5: Drug Labels, Package Inserts, and References Egler • Booth5-*Drug Labels and Package Inserts5-*Learning ObjectivesIdentify 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:5-*Learning Objectives (con’t)Recognize different types of tablets and capsules.Distinguish administration routes for medications.Locate additional information in a package insert.5-*IntroductionNow 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.5-*Locating Information on Drug Labels and Package InsertsDrug nameForm of the drugDosage strengthTotal amount in the containerWarningsRoute of administrationStorage requirementsManufacturing information5-*Drug NameGeneric name = official nameBy law this name must appear on the label.Levothyroxine Sodium = Synthroid(generic name) (trade name)Trade name = brand name used to market the drug5-*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.5-*Drug Name (con’t)You must know both the generic and trade names of drugs.ExampleVicodin® is a narcotic painkillerGeneric name: hydrocodone bitartrate and acetaminophenOther trade names: Anexsia®, Lortab®, Zydone®5-*Form of the DrugsSolid oral medicationstablets, capsules, gelcaps, capletsLiquidsoral, injections, inhalants, drops, sprays, mistsOtherointments, creams, lotions, patches, suppositories, shampoos5-*Dosage StrengthDrug 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 Units5-*Dosage Strength (con’t)Solid medicationsDosage strength is the amount of drug present per tablet, capsule, or other form5-*Dosage Strength (con’t)Liquid medicationsDosage strength is the amount of drug present in certain quantity of solutionYou need to know both the amount of drug and the amount of total solutionAmount of solution varies per dosage unitPharmaceutical companies manufacture meds with dosage strengths that match commonly prescribed drugs5-*Combination DrugsGeneric 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)5-*Total Number or Volume in ContainerMany oral meds are packaged in unit dosesa single tabletvial with 2 mL of solution for injectionMultiple-dose containersone container with 50 gelcapsNonprescription medication often packaged in multiple-dose containers5-*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.5-*Route of AdministrationDirections 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.5-*Route of Administration (con’t)Tablets/Capsulesorallysublinguallychewable Liquids orally injection5-*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.5-*WarningsHelp to administer drugs safely“May be habit forming.”“Not safe for pregnant women or children.”“Keep under close observation of a physician.”Disposal of drugsFollow guidelines of facility.For example, flush narcotics with a coworker as witness, then appropriately document.5-*Storage InformationTo maintain the drug’s potency and effectivenessInformation will appear on labelstorage temperatureexposure to lightlength of time drug will remain potent after container has been openedStorage at the wrong temperature or exposure to light can trigger a chemical reaction and make the drug unusable.5-*Manufacturing InformationLabels are regulated by the U.S. Food and Drug Administration (FDA) and must include:Name of the manufacturerExpiration dateabbreviated EXP, after which the drug may no longer be usedLot number indicates when and where a drug was producedallows manufacturer to trace problems5-*Manufacturing Information (con’t)Never use a drug after the expiration date has passed.Older drugs may become chemically unstable or altered.5-*Information About Reconstituting DrugsPowder 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.5-*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.5-*Package InsertsProvide complete and authoritative information about a medication:Description -- chemical and physical description of the drugClinical Pharmacology -- actions of the drugIndications and UsageContraindications5-*Package Inserts (con’t)WarningsPrecautionsAdverse ReactionsOverdosageDosage and AdministrationPreparation for AdministrationManufacturer Supply5-*Review and PracticeBiaxin® 500 mg tabletsWhat 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)5-*Oral DrugsOral medications are available either in solid or liquidsTabletsScored -- can be broken into equal portionsChewable -- must be chewed to be effectiveEnteric-coated -- must be swallowed wholeCapsules should be swallowed wholemay be opened and mixed with foodSustained-release -- must be swallowed whole5-*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.5-*Oral Drugs (con’t)Abbreviations such as SR, CR, and ER listed after the drug name indicates a special drug actionSR = sustained releaseCR = controlled releaseER = extended-release5-*Oral Drugs (con’t)LiquidsOral SolutionsSyrupsElixirsOral SuspensionSimply Liquids5-*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.5-*Review and PracticeLexapro®OrallyWhat is the trade name of the drug?How should this medication be administered?What is the dosage strength?10 mg/tablet5-*Parenteral DrugsPackaged asSingle-use ampules or vialsSingle-use prefilled syringesMulti-use vialsSmall containers have small labelsDifficult to readOften need to review package insert5-*Parenteral Drugs (con’t)RoutesIntradermally (ID)Intramuscularly (IM)Intravenously (IV)Subcutaneously (Sub-Q)InhalantsTransdermal delivery5-*Parenteral Drugs (con’t)Dosage strength expressed asratiomg or mcgunitspercentmEq5-*Review and Practice0.2 mg/mLFurosemideWhat is the dosage strength of the drug?What is the drug’s name?What is the route of administration?IM or IV5-*Drugs Administered by Other RoutesSublingually (under the tongue)Buccally (between the tongue and cheek)Rectally VaginallyTopicalEye or Ear dropsTransdermalInhalants5-*Drugs Administered by Other Routes (con’t)Dosage StrengthVaries according to medication Examplesmay be written as 0.2 mg/hr (absorbed over time through the skin)or 84 mcg (dosage per metered spray)5-*Review and PracticeWhat is another name for the brand name?Answer: trade nameAnswer: generic nameWhat is the official name of a drug?5-*Review and PracticeTrue or FalseEnteric-coated tablets can be crushed and mixed with food.Answer: FalseAnswer: TrueCapsules may be opened and mixed with food.5-*Review and PracticeTrue or FalseYou may administer a drug after the expiration date has expired if you do not have any new ones.Answer: FalseAnswer: FalseYou can use as much solution as you need to reconstitute a powdered medication.5-*Drug Labels and Package InsertsMake sure you know exactly what is found on a drug label, and do not forget to read the fine print. 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