1. 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

2. 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.

3. 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.

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

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

6. 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)

7. 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.

8. 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®

9. 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

10. 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.

11. 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

12. 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.

13. 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.

14. 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

15. 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.

16. 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

17. 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.

18. 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

19. 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

20. 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

21. 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.

22. 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

23. 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.

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

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

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

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

28. 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

29. 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)

30. 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

31. 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 1400

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

33. 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

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

35. 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

36. 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

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

38. 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

39. 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

40. 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

41. 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.

42. 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

43. End of Chapter 6
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-Henry Fielding