Package Insert

What type of information can be found on a package insert?
-black box warnings
-description of product
-clinical pharmacology
-indications and usage/contraindications/warnings/precautions
-adverse reactions
-dosage and administration
-storage/stability
-how supplied
What is included in the 2006 revision?
-highlights
-table of contents
-date of initial product approval
-toll free number and internet address
What do black box warnings alert about?
They alert HCPs about any important safety concerns such as serious side-effects or life-threatening risks
What are HCPs?
health care providers
What are black box warnings named for?
black border surrounding the text of the warning
What is the most serious medication warning required by the FDA (and still remain on the market in the US)?
black boxed warnings
What is included in the description of the product?
-generic name
-chemical name
-structure
-color, formulation, strength, order, etc.
What is included in the clinical pharmacology of a medication?
-how medicine works
-absorption, distribution, metabolism, elimination
-effects at various studies
-effects on various populations
What describes how a medication works?
mechanism of action (MOA)
What describes the uses (treatment and prevention) for which the drug has been FDA-approved?
indications and usage
What indications and usage may an antibiotic have?
a list of specific infections and bugs
What section of a package insert lists situations in which the medication should NOT be used?
contraindications
What are two examples of contraindications that may be seen?
-known hypersensitivity to this or similar products
-patients with other medical conditions or kidney problems
What is included in the warning section of a package insert?
possible SERIOUS side effects that may occur
What is an example of a warning?
Clostridium dificile associated with diarrhea has been reported with the use of antibacterials
What section of a package insert explains how to use the medication safely including physical impairments and drug interaction?
precautions
What is included in the precautions?
-drug/drug interactions and drug/lab interactions
-information on special populations (pediatrics, geriatrics, pregnancy, and nursing)
What is this an example of?: When “this drug” is administered to patients with impaired renal function, lower daily dosage is required (see DOSAGE AND ADMINISTRATION)
precautions
What are adverse reactions?
lists all side effects observed in all studies of the drug (as opposed to just the dangerous side effects which are separately listed in “Warnings” section)
The frequency of adverse reactions may be reported in what?
percentages (>1% or <1%)
(T/F) Precautions may include information from both clinical trial experiences and post-marketing experiences?
false; adverse reactions
What is the purpose of the dosage and administration section?
-gives recommended dosage(s)
-different disease states or patient populations
-administration may include instructions for dilution (reconstitution) and a list of compatible solutions for further dilution
-preparation of specialty products (ADD-Vantage)
What is proper storage and stability?
-original container; after reconstitution
-room temperature, refrigerator, freezer
What section of a package insert explains the physical characteristics of the medication (color, shape, markings, etc) and product sizes available?
how supplied