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  1. 1. MATH AND DOSAGE CALCULATIONS FOR HEALTH CARE THIRD EDITION BOOTH & WHALEY McGraw-Hill 6- Chapter 6: Drug Labels and Package Inserts Edited by B. Holmes MSN/Ed, RN
  2. 2. LEARNING OUTCOMES <ul><li>6.1 Identify on a drug label the drug name, form, dosage strength, route, warnings, and manufacturing and storage information. </li></ul><ul><li>6.2 Locate directions on drug labels and package inserts for reconstituting and diluting medications. </li></ul>6-
  3. 3. LEARNING OUTCOMES <ul><li>6.3 Recognize different types of tablets and capsules. </li></ul><ul><li>6.4 Distinguish administration routes for medications. </li></ul><ul><li>6.5 Locate additional information in a package insert. </li></ul>6-
  4. 4. INTRODUCTION <ul><li>The drug label and package inserts contain information needed to perform dosage calculations. </li></ul><ul><li>Read the label carefully. </li></ul>6-
  5. 5. LOCATING INFORMATION <ul><li>Drug name </li></ul><ul><li>Form of the drug </li></ul><ul><li>Dosage strength </li></ul><ul><li>Total amount in the container </li></ul><ul><li>Warnings </li></ul><ul><li>Route of administration </li></ul><ul><li>Storage requirements </li></ul><ul><li>Manufacturing information </li></ul>6-
  6. 6. DRUG NAME <ul><li>Generic Name </li></ul><ul><ul><li>Official name </li></ul></ul><ul><ul><li>Must appear on label </li></ul></ul><ul><ul><li>National listings </li></ul></ul><ul><ul><ul><li>United States Pharmacopeia (USP) </li></ul></ul></ul><ul><ul><ul><li>National Formulary (NF) </li></ul></ul></ul>6- Levothyroxine Sodium (generic name)
  7. 7. DRUG NAME (CONT.) <ul><li>Trade Name </li></ul><ul><ul><li>Brand name </li></ul></ul><ul><ul><li>Used to market the drug </li></ul></ul><ul><ul><li>Property of drug company </li></ul></ul><ul><ul><ul><li>Registered mark ® - name registered with the U.S. Patent and Trademark Office </li></ul></ul></ul><ul><ul><li>Drug may be manufactured by more than one company. </li></ul></ul>6- Synthroid (trade name)
  8. 8. DRUG NAME (CONT.) <ul><li>Rule 6-1 </li></ul><ul><li>You must know both the generic and trade names of drugs. </li></ul>6- Example Vicodin ® is a narcotic painkiller Generic name : hydrocodone bitartrate and acetaminophen Other trade names : Anexsia ® , Lortab ® , Zydone ®
  9. 9. FORM OF THE DRUGS <ul><li>Solid oral medications </li></ul><ul><ul><li>Tablets, capsules, gelcaps, caplets </li></ul></ul><ul><li>Liquids </li></ul><ul><ul><li>Oral, injections, inhalants, drops, sprays, mists </li></ul></ul><ul><li>Other </li></ul><ul><ul><li>Ointments, creams, lotions, patches, suppositories, shampoos </li></ul></ul>6-
  10. 10. DOSAGE STRENGTH <ul><li>Labels include information about the amount of drug present. </li></ul><ul><li>The amount of drug present per dosage unit combined with information about the form identifies the drug’s dosage strength. </li></ul>6-
  11. 11. DOSAGE STRENGTH (CONT.) <ul><li>Solid medications </li></ul><ul><ul><li>Dosage strength is the amount of drug present per tablet, capsule, or other form. </li></ul></ul>6- Dosage strength 10 mg/1 tab
  12. 12. DOSAGE STRENGTH (CONT.) <ul><li>Liquid medications </li></ul><ul><ul><li>Dosage strength is the amount of drug present in a quantity of solution. </li></ul></ul><ul><ul><li>Amount of solution varies per dosage unit. </li></ul></ul><ul><ul><li>Pharmaceutical companies manufacture meds with dosage strengths that match commonly prescribed doses. </li></ul></ul><ul><ul><ul><li>Reduces the risk of error when calculating dosages. </li></ul></ul></ul>6-
  13. 13. COMBINATION DRUGS <ul><li>Generic names and dosage strengths of all components must appear on the label. </li></ul><ul><li>If available, the trade name may be used to order combination drugs. </li></ul>6-
  14. 14. TOTAL NUMBER OR VOLUME IN CONTAINER <ul><li>Many meds are packaged in unit doses </li></ul><ul><ul><li>One tablet / section of package </li></ul></ul><ul><ul><li>Vial with 2 mL of solution for injection </li></ul></ul><ul><li>Multiple-dose containers </li></ul><ul><ul><li>Prescription medications </li></ul></ul><ul><ul><li>Non-prescription medications </li></ul></ul>6-
  15. 15. TOTAL NUMBER OR VOLUME IN CONTAINER (CONT.) <ul><li>Rule 6-2 </li></ul><ul><li>Do not confuse the total amount of drug in the container with the dosage strength. </li></ul>6- The container may hold 100 tablets and each tablet has a dosage strength of 2.5 mg per tablet.
  16. 16. ROUTE OF ADMINISTRATION <ul><li>Directions for route of administration may be on the label. </li></ul><ul><ul><li>Tablets, capsules, gelcaps, caplets </li></ul></ul><ul><ul><ul><li>Swallow </li></ul></ul></ul><ul><ul><ul><li>Sublingual </li></ul></ul></ul><ul><ul><ul><li>Chewable </li></ul></ul></ul><ul><ul><li>Liquid medications </li></ul></ul><ul><ul><ul><li>Oral </li></ul></ul></ul><ul><ul><ul><li>Injections </li></ul></ul></ul><ul><ul><li>Inhalants </li></ul></ul><ul><ul><li>Topical / transdermal </li></ul></ul>6-
  17. 17. ERROR ALERT! <ul><li>Give the right medication by the right route. </li></ul><ul><ul><li>Do not administer drugs by any route other than described in the drug label or on the order. </li></ul></ul>6-
  18. 18. WARNINGS <ul><li>Help to administer drugs safely </li></ul><ul><li>Types of warnings </li></ul><ul><ul><li>For specific groups, i.e. children, elderly </li></ul></ul><ul><ul><li>For controlled substances </li></ul></ul><ul><ul><li>About combining with other drugs or products </li></ul></ul><ul><li>Proper disposal following facility guidelines </li></ul>6-
  19. 19. STORAGE INFORMATION <ul><li>Maintain the drug’s potency and effectiveness </li></ul><ul><li>Information on label </li></ul><ul><ul><li>Storage temperature </li></ul></ul><ul><ul><li>Exposure to light </li></ul></ul><ul><ul><li>Length of time drug will remain potent after container has been opened </li></ul></ul><ul><li>Improper storage can trigger a chemical reaction and make the drug unusable </li></ul>6-
  20. 20. MANUFACTURING INFORMATION <ul><li>Labels </li></ul><ul><ul><li>Regulated by the U.S. Food and Drug Administration (FDA) </li></ul></ul><ul><ul><li>Must include: </li></ul></ul><ul><ul><ul><li>Name of the manufacturer </li></ul></ul></ul><ul><ul><ul><li>Expiration date </li></ul></ul></ul><ul><ul><ul><li>Lot number </li></ul></ul></ul><ul><ul><ul><ul><li>When and where a drug was produced </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Trace problems </li></ul></ul></ul></ul>6-
  21. 21. MANUFACTURING INFORMATION (CONT.) <ul><li>Rule 6 - 3 </li></ul><ul><li>Never use a drug after the expiration date has passed. </li></ul><ul><ul><li>Older drugs may become chemically unstable or altered. </li></ul></ul><ul><ul><ul><li>Incorrect dose </li></ul></ul></ul><ul><ul><ul><li>Effect different than intended one </li></ul></ul></ul><ul><ul><li>Educate patients to check expiration dates. </li></ul></ul>6-
  22. 22. INFORMATION ABOUT RECONSTITUTING DRUGS <ul><li>Powder forms must be reconstituted and other drugs require dilution prior to use. </li></ul><ul><li>Directions for reconstituting or diluting are on the label. </li></ul><ul><ul><li>Type and amount of diluent </li></ul></ul><ul><ul><li>Solution strength once reconstituted </li></ul></ul><ul><ul><li>Time period for safe administration </li></ul></ul>6-
  23. 23. ERROR ALERT! <ul><li>Consider the age and health needs of the patient when administering a drug. </li></ul><ul><ul><li>If another form of a drug is better suited to a patient’s needs, consult the physician or pharmacist about changing the order. </li></ul></ul>6-
  24. 24. PACKAGE INSERTS <ul><li>Complete and authoritative information about a medication </li></ul><ul><li>Sections </li></ul><ul><ul><li>Description – chemical and physical </li></ul></ul><ul><ul><li>Clinical Pharmacology – actions of the drug </li></ul></ul><ul><ul><li>Indications and Usage </li></ul></ul>6-
  25. 25. PACKAGE INSERTS (CONT.) <ul><ul><li>Contraindications </li></ul></ul><ul><ul><li>Warnings – serious side effects </li></ul></ul><ul><ul><li>Precautions </li></ul></ul><ul><ul><li>Adverse Reactions – anticipated side effects </li></ul></ul>6-
  26. 26. PACKAGE INSERTS (CONT.) <ul><ul><li>Overdosage – effects and instruction for treatment </li></ul></ul><ul><ul><li>Dosage and Administration </li></ul></ul><ul><ul><li>Preparation for Administration </li></ul></ul><ul><ul><li>Manufacturer Supply – dosage strength and form availability </li></ul></ul>6-
  27. 27. PRACTICE 6- What is the generic name of the drug? Answer At 25 ° C (77 °F) excursions permitted to 1 5-30°C (59-86°F) Answer 50 mg capsules What is the dosage strength? How should this drug be stored? Answer celecoxib
  28. 28. ORAL DRUGS <ul><li>Solid or liquid forms </li></ul><ul><li>Tablets </li></ul><ul><ul><li>Scored – can be broken into equal portions </li></ul></ul><ul><ul><li>Chewable – should be chewed to be effective </li></ul></ul><ul><ul><li>Enteric-coated – must be swallowed whole </li></ul></ul><ul><ul><li>Capsules </li></ul></ul><ul><ul><ul><li>Some should be swallowed whole </li></ul></ul></ul><ul><ul><ul><li>Others may be opened and mixed with food </li></ul></ul></ul><ul><ul><li>Controlled-release – usually swallowed whole </li></ul></ul>6-
  29. 29. ORAL DRUGS (CONT.) <ul><li>Rule 6 - 4 </li></ul><ul><li>Tablets may be broken to give a partial dose only when the tablets are scored. </li></ul><ul><ul><li>Never crush or break </li></ul></ul><ul><ul><ul><li>Enteric-coated medications </li></ul></ul></ul><ul><ul><ul><li>Controlled-release medications (CR) </li></ul></ul></ul><ul><ul><ul><li>Extended-release medications (ER or XL) </li></ul></ul></ul><ul><ul><ul><li>Sustained-release medications (SR) </li></ul></ul></ul>6-
  30. 30. ORAL DRUGS (CONT.) <ul><li>Liquids </li></ul><ul><ul><li>Oral solutions </li></ul></ul><ul><ul><li>Syrups </li></ul></ul><ul><ul><li>Elixirs </li></ul></ul><ul><ul><li>Oral suspensions </li></ul></ul><ul><ul><li>Simple liquids </li></ul></ul><ul><ul><li>Dosage strength corresponds to a specific volume of the solution – </li></ul></ul><ul><ul><li>500 mg / 10 mL </li></ul></ul>6-
  31. 31. ORAL DRUGS (CONT.) <ul><li>Rule 6 - 5 </li></ul><ul><li>When reconstituting a drug, you must write your initials and the time and date of reconstitution on the label. </li></ul>6- shf 7/21/08 @ 1400
  32. 32. PRACTICE 6- 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
  33. 33. PARENTERAL DRUGS <ul><li>Packaged as </li></ul><ul><ul><li>Single-use ampules or vials </li></ul></ul><ul><ul><li>Single-use prefilled syringes </li></ul></ul><ul><ul><li>Multi-use vials </li></ul></ul><ul><li>Small containers have small labels </li></ul><ul><ul><li>Difficult to read </li></ul></ul><ul><ul><li>Review package insert </li></ul></ul>6-
  34. 34. PARENTERAL DRUGS (CONT.) <ul><li>Routes </li></ul><ul><ul><li>Intradermally ( ID ) </li></ul></ul><ul><ul><li>Intramuscularly ( IM ) </li></ul></ul><ul><ul><li>Intravenously ( IV ) </li></ul></ul><ul><ul><li>Subcutaneously ( Sub-q ) </li></ul></ul><ul><ul><li>Inhalants </li></ul></ul><ul><ul><li>Transdermal Delivery </li></ul></ul>6-
  35. 35. PARENTERAL DRUGS (CONT.) <ul><li>Dosage strength is the amount of drug per dosage unit </li></ul><ul><ul><li>Examples </li></ul></ul><ul><ul><ul><li>mg / tablet </li></ul></ul></ul><ul><ul><ul><li>mg / mL </li></ul></ul></ul><ul><ul><ul><li>mEq / mL </li></ul></ul></ul><ul><ul><li>units / mL </li></ul></ul><ul><ul><li>gm / mL </li></ul></ul><ul><ul><li>gm / tablet </li></ul></ul>6-
  36. 36. PRACTICE 6- 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
  37. 37. DRUGS ADMINISTERED BY OTHER ROUTES <ul><li>Sublingual (under the tongue) </li></ul><ul><li>Buccal (between the tongue and cheek) </li></ul><ul><li>Rectal </li></ul><ul><li>Vaginal </li></ul><ul><li>Topical </li></ul><ul><li>Eye or Ear drops </li></ul><ul><li>Transdermal </li></ul><ul><li>Inhalants </li></ul>6-
  38. 38. DRUGS ADMINISTERED BY OTHER ROUTES (CONT.) <ul><li>Dosage strength varies with type of drug and how it is administered </li></ul><ul><ul><li>Examples </li></ul></ul><ul><ul><ul><li>Transdermal – 0.2 mg/hr (the amount absorbed over time through the skin) </li></ul></ul></ul><ul><ul><ul><li>Inhalent – 84 mcg / metered spray </li></ul></ul></ul>6-
  39. 39. APPLY YOUR KNOWLEDGE <ul><li>1. What is another name for the brand name? </li></ul><ul><li>2. What is the official name of a drug? </li></ul>6- <ul><ul><li>Answer trade name </li></ul></ul><ul><ul><li>Answer generic name </li></ul></ul>
  40. 40. APPLY YOUR KNOWLEDGE <ul><li>True or False </li></ul><ul><li> Enteric-coated tablets can be crushed and mixed with food. </li></ul><ul><li> All capsules may be opened and mixed with food. </li></ul><ul><li> Parenteral forms of drugs includes transdermal and inhalants. </li></ul>6- T F F This would allow the drug to be absorbed sooner than intended. Some capsules should be swallowed whole.
  41. 41. APPLY YOUR KNOWLEDGE <ul><li>True or False (cont.) </li></ul><ul><li> The warnings section of a package insert lists the more serious, possibly fatal, side effects of a drug. </li></ul><ul><li> You may administer a drug after the expiration date has expired if you do not have any new ones. </li></ul>6- T F It may not provide correct dosage strength or have an effect different than intended.
  42. 42. APPLY YOUR KNOWLEDGE <ul><li>True or False (cont.) </li></ul><ul><li> You can use as much solution as you need to reconstitute a powdered medication. </li></ul><ul><li> The amount of drug in a container is not the same as the dosage strength. </li></ul>6- F You must follow the directions for reconstituting a drug that are on the label or in the package insert. T
  43. 43. END OF CHAPTER 6 6- Read in order to live. -Henry Fielding