C HAPTER 6 D RUG LABELS AND P ACKAGE INSERTS

C HAPTER 6 D RUG LABELS AND P ACKAGE INSERTS 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. 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. Chapter Outline 6-1 Locating Information on Drug Labels and Package Inserts 6-2 Oral Drugs 6-3 Parenteral Drugs 6-4 Drugs Administered by Other Routes Lesson Plan Anticipatory Set Finding Drug Information. Gather as many drug labels and package inserts as you can. Your goal would be to have at least one of each for each student in your class. From each drug label and package insert select on piece of unique information and create a list of this information in handout or presentation format. For each unique piece of information identify the medication keep this list as your answers. Make sure to identify all types of information from the package inserts or drug labels. i.e. storage information, warnings, dosage strength, chemical name, contraindications etc.use the figure tags for Chapter 6 for drug labels and Table 6-1, Sections of a Package Insert, as reference to create your list. Provide the students with the list and then pass around the drug labels and package inserts and have the student determine the drug that is represented by the information on your list. Review the correct answer with the student once they have completed. Teaching Strategies Assign and collect the homework for Chapter 6. Check the student s answers to discover the topics within the chapter that require the most focused attention during class time. Have a health care professional visit the class and discuss their role in dosage calculations as well as the importance of math accuracy and preventing medication errors in the health care profession. Have students review the key terms for Chapter 6 using the Audio glossary and Key Term Concentration game on the student CD. Have students in groups of three; review their basic math skills using the Math Challenge game on the student CD. Encourage students to complete each review and practice section in the text/workbook and check their answers. You can also remove the answers from the back of the book and use the review and practice questions as a graded assignment. Use the Critical Thinking on the Job Activities from Chapter 6 as Think-Pair-Share assignments in class. Have student groups discuss their answers and present to the rest of the class. Use the PowerPoint presentation for Chapter 6, found on the student and instructor resource CD-ROM, for a class lecture and/or review. Use the Test Your Knowledge questions for discussion. The online learning center at www.mhhe.com/ MathDosage3e contains additional activities for each chapter. Links for the Internet activities from at the end of this chapter are provided on this site. Have students navigate to this site to complete the Internet activities. Play the Spin the Wheel on the student CD with individual, small groups or within the classroom in preparation for the final evaluation. Assess Use the Additional Exercises for Chapter 6 found at the end of this document for reinforcement of chapter concepts. These exercises can also be used as chapter quizzes. Instructor s Manual for Math and Dosage Calculations for Health Care 61

Students should complete each student CD activity when directed within the text. Have students save, print, or email their completed Progress Report from the student CD for Chapter 6. The chapter review should be completed and checked in preparation for the final chapter evaluation. Using the EZTest test bank for Chapter 6, create a written test in two versions for a final evaluation of student s proficiency. Access the Instructor s Manual documents in electronic format and modify to match your curriculum needs. Use the chapter images and labels to create your own worksheets, tests, or PowerPoint presentations. C HAPTER 6 Solutions Critical Thinking on the Job: Read Labels Carefully: In this example, the health care professional made an initial mistake. He did not carefully compare the drug order with the drug label. Looking at Figures 6-19 and 6-20, you may think that the health care professional s error was reasonable given the similarity between the labels. Still, this error should have been avoided. The health care professional should have read the label 3 times before trying to administer the drug. This rule is especially important when you administer a drug that is available in different dosage strengths or is designed for different routes of administration. Fortunately, the patient gave the health care professional an opportunity to catch the error. When she questioned the color, the health care professional should listen to the patient and recheck his work. However, if he had not listened, or if the patient had not alerted him, he may have administered 3 times the amount of the drug that was ordered. REVIEW AND PRACTICE: 6-1 Locating Information on Drug Labels and Package Inserts 1. The trade name is Nexium, indicated by the registration mark. 2. esomeprazole magnesium 3. It holds multiple doses. The label says there are 90 delayed-release capsules. 4. Astra Zeneca 5. 20 mg/capsule 6. 25 C (77 F) excursions permitted to 15 30 C (59 86 F) 7. clorazepate dipotassium 8. The trade name is Tranxene, indicated by the registration mark. 9. 15 mg/tablet 10. T-TAB 11. 03-2431-5/R2 (4391) 12. It should be protected from moisture and stored at a temperature below 77 F (25 C). The bottle should be kept tightly closed, dispense in a USP tight, light-resistant container. 13. The trade name is IntronA, indicated by the registration mark. 14. Schering Corp. 15. 5 million IU/0.5 ml 16. injection 17. Refrigerate between 2 and 8 C (36 and 46 F). 18. The label does not indicate the usual dose of the medication or how to inject the drug so you would review the package insert to determine these things. 19. cefdinir 20. Orally. The label states that the medication is a syrup and it describes the dose in teaspoons. 21. Children 14 mg/kg/day in a single dose or divided in two doses. 22. 125 mg/5 ml 23. You would administer 10 ml or 2 teaspoons. 62 Instructor s Manual for Math and Dosage Calculations for Health Care

24. 6 days Daily dose would be 20 ml Two bottles would have 120 ml 120 divided by 20 6 days 25. furosemide 26. There is no registration mark, so this is a generic drug only. It has no trade name. 27. Intramuscular (IM) or intravenous (IV) injection 28. Protect from light. Do not use if discolored. Use only if solution is clear. Store at 20º to 25º C (68º to 77º F) [see USP Controlled room Temperature] 29. 40 mg 30. Usual dose is not given on the label. However, if a usual dose is 10 mg then there are 4 doses in this vial. 31. 75 ml of suspension when reconstituted 32. Add to the bottle a total of 59 ml water. For ease in preparation, add the water in two portions. Shake well after each addition. 33. A total of 59 ml are to be added. So 30 ml are added initially. 34. 125 mg/5 ml 35. Stored in the refrigerator and discarded after 14 days. 36. Once the drug is reconstituted, it contains 75 ml. If the usual dose is 5 ml, then 15 doses are available (15 5 ml 75 ml). Furthermore, if the usual dose is 5 ml, then 125 mg of cefprozil are in the usual dose. 37. There is no registration mark, so this is a generic drug only. It has no trade name. 38. Metformin hydrochloride is the generic name of the drug. 39. 500 mg/tablet 40. At 15 to 30ºC or 59 to 86ºF in a light-resistant container 41. Orally. The label states that the medication is a tablet. 42. 90 tablets in the bottle divided by 30 tablets in each prescription equals three prescriptions per bottle. 43. Caraco is the manufacturer. 44. B, G 45. A, B, D, F, G 46. A 47. F, C, E. will last longer if refrigerated D. may be refrigerated 48. C, E 49. D, F 50. G REVIEW AND PRACTICE: 6-2 Oral Drugs 1. 57664-474-99 2. 1000 mg/ tablet 3. Yes, the label states to store in a controlled room temperature 15º to 30º C (59º to 86º F). 4. 90 tablets are in this container. 5. Levoxy 6. King Pharmaceuticals 7. 50 mcg/tablet 8. 100 tablets 9. famotidine 10. injection 11. 20 mg/2 ml 12. Intravenous Use Only After Dilution 13. 60 ml of water should be used. For ease in preparation tap bottle to loosen powder, add the water in two portions, shaking well after each addition. 14. 250 mg/5 ml Instructor s Manual for Math and Dosage Calculations for Health Care 63

15. 100 ml 16. 14 days. The label instructs the user to discard the suspension after 14 days. 17. The generic name is rimantadine hydrochloride. 18. 100 mg/tablet 19. Flumadine 20. Storage at a controlled room temperature 15 to 30º C (59º to 86º F). 21. B. Levoxyl, E. Flumadine 22. C. Famotidine and D. Amoxicillin because they are both liquids 23. D. Amoxicillin 24. A. Metformin, B. Levoxyl, D. Amoxicillin in powder form only, E. Flumadine (C. Famotidine does not indicate the storage information on the label.) 25. A. Metformin, B. Levoxyl, E. Flumadine REVIEW AND PRACTICE: 6-3 Parenteral Drugs 1. 10 mg/ml 2. Via intravenous injection only 3. Use strict aseptic technique. Contamination can cause fever, infection, and/or life threatening illness; single-patient use; contains no preservatives; supports microbial growth. Begin use promptly after opening; Discard within specifications; Do not use if contaminated. Shake well before using. 4. See package insert. 5. 200 mg erythromycin and 600 mg sulfisoxazole per 5 ml 6. Ross Pediatrics 7. erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension 8. Yes. The label clearly indicates how to mix the medication. 9. Store at controlled room temperature 20º to 25º C (68º to 77º F). 10. 0.5 mcg/1 capsule 11. Orally, it is a capsule 12. The container holds 50 capsules. If one dose is 2 capsules then the container holds 25 doses. 13. rdna (human origin) 14. 100 units/ml 15. insulin lispro injection 16. 100 doses; the container holds 10 ml. A dose of 10 Units requires 0.1 ml. Therefore, 100 doses of 10 Units are in 10 ml. 17. 100 mg/ml 18. trimethobenzamide HCl 19. If each dose is 100 mg, then 20 doses would be in the container. The number of doses always depends on the size of each dose and the total amount in the container. 20. Storage should be at 25 C (77 F). Critical Thinking on the Job: Avoid Unnecessary Risks: The health care professional should send the vial back to the pharmacy for a replacement because when she returned and read the drug label, she noticed that you should not start the administration more than two hours after Gammagard S/D is reconstituted. Since she reconstituted at 0830 and it is now 1100, it has been 2 1_ hours and the 2 drug should not be administered. By sending the medication back to the pharmacy the health care professional observed the special instructions on the drug label and, in turn, protected the patient s rights. 64 Instructor s Manual for Math and Dosage Calculations for Health Care

REVIEW AND PRACTICE: 6-4 Drugs Administered by Other Routes 1. Albuterol sulfate 2. 90 mcg per actuation 3. See package insert for prescribing information. No usual dosage is listed. 4. Store between 15 and 25 C (59 and 77 F) 5. Topically. The label states for topical use only. 6. Store refrigerated 2-8 C (36-46 F). 7. 0.01% of the gel 8. Becaplermin; the label states that the drug contains becaplermin 0.01%. Also, 0.01% is listed after the trade name. 9. Intranasal (nasal spray) 10. 50 mcg/spray 11. 28 metered sprays 12. No; the label reads For Intranasal Use Only. 13. Transdermally via a patch on the skin 14. 100 mg/h for 72 h 0004-0237-09 1. granisetron HCL CHAPTER 6 HOMEWORK SOLUTIONS 2. store at 25 C (77 F), excursions permitted to 15 to 80 C (59 to 86 F), protect from light, keep bottle tightly closed, store in upright position. 3. 30 ml 4. 10 ml NDC 0004-0237-09 KYTRIL (granisetron HCl) ORAL SOLUTION 2 mg/1o ml 3O ml 5. Rocephin 6. IM and IV only. Store at 25 C (77 F); excursions permitted to 15 to 30 C (59 to 86 F). Protect From Light. Keep bottle closed tightly and stored in an upright position. Each 10 ml contains 2.24 mg granisetron hydrochloride equivalent to 2 mg granisetron. Usual Dosage: See accompanying prescribing information. Distr. by: Roche Laboratories Inc. Nutley, New Jersey 07110 Made in UK 40230US1 27897835-0401 Label A 7. reconstitute with 1 ml 1% Lidocaine HCL injection or Sterile Water for injection 8. once Lot Exp. 15. Opioid tolerant patients 16. 5 17. Calcitonin-salmon 18. 200 units/spray 19. Intranasal use only 20. 30 Label B 9 Depakote ER 10. Extended-Release Instructor s Manual for Math and Dosage Calculations for Health Care 65

11. 100 tablets 12. Abbott Pharmaceuticals Label C 13. ritonavir 14. 120 doses 15. soft gelatin 16. 30 days below 77 F (25 C) CHAPTER 6 REVIEW Check Up 1. The generic name is the one official name recognized by the United States Pharmacopeia (USP) and the National Formulary (NF). Brand or trade names can be registered by a specific pharmaceutical company with the U.S. Patent and Trademark Office. A drug may have several different trade names, but only one generic name. 2. When the drug is a combination drug containing more than one medication, the drug order is written using the trade name only. 3. IM means intramuscular, or into the muscle. IV means intravenously, or into the vein. 4. Unscored tablets, gelcaps, caplets, entericcoated tablets, and controlled-, sustained-, or extended-release capsules cannot be broken or divided because doing so would change the action or absorption of the drug. 5. You use a package insert whenever there is not enough information on the label to administer the drug correctly. For example, you would use a package insert if you needed information about drug interactions or treatment of overdoses. Label D 17. oral inhalation 18. approximately 250 mcg 19. 100 metered inhalations 20. shake well before using 6. A lot number provides a code that enables a company to know when and where the drug was manufactured. A company can use the lot number to recall a product in the case of contamination. 7. 0.125 mg/1 tablet 8. 100 tablets 9. Caraco Pharmaceutical Laboratories, LTD. 10. The label does not indicate a route; however, tablets should be given orally. 11. flunisolide 12. by oral inhalation Label E 13. 250 mcg per activation 14. 50 metered inhalations 66 Instructor s Manual for Math and Dosage Calculations for Health Care

15. The label does not indicate a route; however, tablets are given orally. 16. 100 mg/1 tablet 17. Meperidine hydrochloride 18. 100 19. rdna origin 20. regular, which means fast-acting 21. by injection 22. 100 units/ml Critical Thinking The tablets would probably be preferable for an adult homeless patient. The oral suspension needs refrigeration, which would not be available to someone living on the streets or in a shelter. In addition, a homeless person might not have adequate facilities to wash the medicine cup. Finally, the tablets can be stored in a much smaller container than the liquid and are therefore more portable. Drug administration extends beyond handing out medications. Although allied health care professionals do not prescribe medications, they are often responsible for educating patients regarding compliance with drug orders. In this situation, compliance with the drug order may be a problem because of lifestyle. The prescribing physician might need to be made aware of the patient s homelessness in order to prescribe a form of the drug that the patient can take safely and efficiently. Case Study 1. In preparation for administering this drug, you would read the package insert, check any warnings on the package insert, and note any warnings on the label. Note that this medication is for pediatric patients and must be diluted for IV use. 2. The drug will need to be administered intravenously. It will need to be diluted before it is administered. You will need to check the label and the package insert for specific directions. 3. This is a single-dose vial. Destroy the remaining medication and dispose of the container, following the guidelines at your facility. Internet Activity Pages on the Internet change frequently. Any URLs listed may have been removed from the Internet by the time you use this text. By doing a search using words such as coumadin and interactions, you will find a variety of sites. Some are easier to understand than others. Following is a sampling of several sites that might be helpful in Mr. Liu s case. www.druginfonet.com/faq/faqcouma.htm provides physicians answers to frequently asked questions about coumadin. www.thriveonline.com/medical offers a variety of patient information on various illnesses. www.healthtouch.com provides drug information, product information, health information, and a health resource directory. Instructor s Manual for Math and Dosage Calculations for Health Care 67