Drug Information Resoures

Question 1

Package Insert 1

Answer 1

•Dosing
•Drug Interactions
•Side effects
Provide healthcare professionals info about medications.

Question 2

Package Inserts 1

Answer 2

Also know as prescribing info or “PI”
•New format puts most recent info first
•Drug approved before June 30,2001 may use the older format

Question 3

Sections of Package Inserts

Answer 3

Intended for healthcare professional includes PT
•NOT intended for patients

Question 4

Highlights section

Answer 4

It’s the first thing

Is help you and other healthcare professionals find important info quickly.Not patients , Box warning

Question 5

Box warnings

Answer 5

Most serious safety alerts that FDA can request for a medicine you

Question 6

Indications and Usage

Answer 6

What diseases or conditions the drug is approved to treat

Question 7

Dosage forms and Strength

Answer 7

Highlights discusses and contraindications when drugs should NOT be used

Question 8

Warnings and Precautions using the drug

Answer 8

Adverse reactions is side effects from taking the drug. Includes FDA’s phone number and web address for med watch program

Question 9

Warnings and precautions using the drug

Answer 9

For: Healthcare professions can report suspected adverse reactions that can be cause by the drug
• Recent major change to the drug

Question 10

Table of contents section

Answer 10

Área to help you find where detailed or specific prescribing info is located in the package

Question 11

Dosage and Administration

Answer 11

Package inserts lists : Recommend doses,dosing schedule and administration requirements