Package Inserts

Question 1

Highlights

Answer 1

-Contains most important prescribing info about benefits/risks of using the drug.
-Helps find important info quickly.
-Contains boxed warnings (most serious safety alerts)

Question 2

Table of Contents

Answer 2

Reference area for the location of detailed/specific prescribing info

Question 3

Indications and Usage

Answer 3

-Lists disease states/conditions the medication is approved to treat.
-Off-label uses are NOT listed on package insert

Question 4

Dosage and Administration

Answer 4

Contains recommended doses, dosing schedules, & administration requirements

Question 5

contraindications

Answer 5

-Lists situations when the medication should NOT be used
-certain disease states
-interacting drugs
-allergic reactions

Question 6

Warnings & Precautions

Answer 6

-Lists situations that require caution while taking the medication
-contains boxed warnings
-lists lab tests that can affect the drug

Question 7

Adverse Reactions

Answer 7

-Lists reported side effects from the drug’s testing phases
-Contains post marketing experience
-Side effects reported AFTER the drug hit he market

Question 8

Drug Interactions

Answer 8

-Lists the most significant drug-drug interactions involving the medication
-Lists lab tests that can affect the drug

Question 9

Use in specific populations

Answer 9

-Lists safety concerns when using the drug during pregnancy, labor & delivery, breastfeeding, in children, and the elderly

Question 10

Characteristics of package inserts:

Answer 10

-FDA requires drug manufacturers to supply a package insert for ALL prescription meds.
-Also known as “prescribing info” or “PIs”
-Intended for use by healthcare professionals NOT patients