Download Chapter 5 Drug Labels and Package Inserts

Math for the Pharmacy Technician:
Concepts and Calculations
Egler • Booth
Chapter 5: Drug Labels, Package
Inserts, and References
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
When you have successfully completed Chapter 5, you will
have mastered skills to be able to:
 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.
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
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
5-6
5-7
Drug Name
Generic name =
official name
 By law this
name must
appear on the
label.
Trade name =
brand name used
to market the
drug
Levothyroxine Sodium = Synthroid
(generic name)
McGraw-Hill
(trade name)
©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
What is the generic name of
the drug?
Biaxin®
What is the dosage
strength?
500 mg tablets
How should this drug
be stored?
McGraw-Hill
between 20-25°C (68-77°F)
©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 sustainedrelease 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®
What is the trade name of the drug?
How should this medication be administered?
What is the dosage strength?
McGraw-Hill
Orally
10 mg/tablet
©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
What is the dosage strength
of the drug?
0.2 mg/mL
What is the drug’s name?
Furosemide
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
What is the official name of a drug?
Answer: generic name
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
Capsules may be opened and mixed with
food.
Answer: True
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.
Answer: False
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
McGraw-Hill
©2010 by the McGraw-Hill Companies, Inc All Rights Reserved