Chapter 6: Package Insert Information Flashcards
What is the primary purpose of the package insert?
To provide practitioners with essential information they need to prescribe the drug safely and effectively for the care of the patients.
Drug inserts have to contain the following sections, per the FDA:
Description
Clinical pharmacology
Indications and usage
Contraindications
Warning/precautions
Adverse reactions
Drug abuse and dependence
Overdosage
Dosage and administration
How supplied
The description section of a package insert includes:
The proprietary name and established name.
Qualitative/quantitative ingredient information .
The clinical pharmacology section of a package insert includes:
Mechanism of action.
Pharmacodynamics (what a drug does to the body).
Pharmacokinetics (study of how a drug is processed by the body).
The indications and usage section of a package insert includes:
What the drug is indicated for
How do use the drug
The usual dosage
The contraindications section of the package insert includes:
The situations in which the drug should not be used, because the risk outweighs any possible benefit
The warnings/precautions section of a package insert includes:
Clinically significant adverse reactions and other potential safety hazards.
The adverse reactions section of a package insert include:
Serious adverse reactions and potential safety hazards
The drug abuse and dependence section of a package insert include:
If the dog is a controlled substance.
Types of abuse that can occur.
Effects resulting from psychological and physical dependence.
The overdosage section of a package insert includes:
Signs symptoms in laboratory findings of acute overdose and general principles of treatment.
The dosage and administration section of a package insert include:
Most common dosage, regimens
Critical differences among population subsets
Monitoring requirements
Therapeutically, important, clinical pharmacological information
The how supply section of a package insert includes:
A concise summary of information concerning the products, dosage forms.
