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Drug Manufacturers, Package Inserts, Monographs
Pharmacy drug manufacturers, package inserts, monographs
5
Pharmacology
Professional
01/11/2013

Additional Pharmacology Flashcards

 


 

Cards

Term
Drug Monograph
Definition

collection of information

about a given drug that’s required by the Food and Drug

Administration (FDA) to describe the characteristics of the

drug. The order of the information must be the same as required by the FDA.

Term
Package Insert
Definition

copy of a drug monograph that accompanies the drug in its package when distributed for sale and

use.

Term
Package Inserts prior to 2001
Definition

Name

boxed warning

description

clinical pharmacology

indications and usage

contraindictions

warnings

precautions

adverse reactions

overdosage

dosage and administration

how supplied

Term
Package Inserts revised
Definition

highlights of prescribing information:

limitations statement

product name

initial date of US approval

boxed warning

recent major changes:

indications and usage

dosage and administration

dosage forms and strength

contraindictions

warnings and precautions

adverse reactions

adverse reactions reporting contact information

drug interaction

use specific populations

patient counseling information statement

 

 

 

Term
Full prescribing Information: Contents
Definition

Boxed Warning

• Indications and Usage

• Dosage and Administration

• Dosage Forms and Strengths

• Contraindications

• Warnings and Precautions

• Adverse Reactions

• Drug Interactions

• Use in Specific Populations 

Drug Abuse and Dependence

• Overdosage

• Description

• Clinical Pharmacology

• Nonclinical Toxicology 

Clinical Studies

References

How supplied storage and handling

patient counseling information

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