Detailed Package Insert Info

Question 1

Indications and usage

Answer 1

Section tells you which disease states or conditions the medication has been approved to treat by FDA

Sometimes it’s NOT listed what the drug treats

Question 2

Off- label use

Answer 2

*Off- label indications are NOT listed in the package insert

*Inserts only list FDA - approved indications

Question 3

Disease and Administration section

Answer 3

• Dose for a medication
•Dose for different disease states and any specific dose for particular age groups, such as kids or adolescents
• Special dosing schedules and administration requirements are listed here.

Question 4

Doseage Forms and Strengths Sections

Answer 4

•If it’s tablet, capsule,syrup, injectable solution, or another form
• Tells strength each form comes in and the description of what is look like

Question 5

Contraindications Section

Answer 5

*Lists situations when a drug should NOT be used
•See warnings about allergic reactions cautions against using the medication with drugs and warning about using the drug in certain disease states.

Question 6

Warnings and Preactutions Section

Answer 6

•It’s list activities or situations that require caution while taking medication, including boxed warning

Question 7

Boxed warning

Answer 7

are the strongest safety alerts that can be required by FDA .Also included in the highlights section

Question 8

Warning and precautions

Answer 8

•warning on side effects
• As well about using med in certain patient populations

•Find notes about labs test

Question 9

Adverse Reactions Sections

Answer 9

•Tells about the side effects from using the drug during its testing phase.
•Showing how many people experienced specific side effects
•Includes info about side effects that were reported AFTER the drug hit the market .

*This part is referred to as the
“post-marketing Experience“ Section.

Question 10

Drug Interactions

Answer 10

Is when drug - drug interactions with the medication.These instances when two or more drugs react with each other.
• how and why the drug interact
•Review the studies about how important the interaction is

Part2 - Interactions can make drug less effective, cause unexpected side effects or increase effect of a particular drug .

Question 11

Use in specific populations section

Answer 11

•Section lists safety concerns when using the drug in certain patients

Question 12

Pregnancy cartgories

Answer 12

•Found in the “Use in specific populations section”
•Based on the risks of harm to the developing

A=safest
B
C
D
X=Riskiest

Ended 2020 A-X

Question 13

New pregnancy Format

Answer 13

New format for drugs approved after June 2001
Drug approved before June 30,2001 will still have category rating and aren’t required to change to the new format at this time

Question 14

New pregnancy Format & Use in specific populations Section

Answer 14

•Includes info about any risks from using the drug during labor and delivery, while breastfeeding in kids and in the elderly

Oversimplify I for pregnancy categories in package inserts tend

•The new format will provide info for prescribers to make better informed decisions.