Hightlights Section
“Most Important info”
- Boxed warnings (most serious info)
- Diseases/conditions approved to treat
- Drug doses
- Administration requirements
- Available dosage forms/strengths
- Contraindications (when a drug should not be used)
- Warnings/precautions
- Most common side effects (includes phone # and website for FDA’s MedWatch program, which is set up to report suspected adverse reactions that could be caused by drug)
- Significant drug interactions
- Recent major changes
Table of contents
help locate information in insert
Indications and Usage
lists disease states/conditions the med is approved to be treated (approved by FDA)
Off Label Use
- when a drug is used for a disease state/condition not listed in Indications and Usage section of a PI
PI
Package Insert
Dosage and Administration
contains recommended doses (for disease states, particular age group), dosing schedules, and administration requirements
Contraindications
lists situations whens the med should not be used
- Allergic reactions
- Interacting drugs
- warnings (about using in certain states)
Warnings and Precautions
lists situations that require caution while taking med
- serious reactions
- serious side effects
- warnings of using med in certain populations
- Warnings of using med in those with certain disease states
- Lab tests may be affected
Adverse Reactions
reported side effects (found in testing)
- side effect charts
- side effects reported after it hit the market “Post marketing experience”
Drug Interactions
lists most significant drug-drug reactions involving the med
- mechanism of drug interactions
- explains how and why
- reviews the studies about how important the interaction is
- How drug affects lab tests
Use in Specific Populations
lists safety concerns when using the drug during pregnancy, during labor, and delivery, while breastfeeding, in children, and in the elderly
Pregnant Categories under Use in Specific Populations
A, B, C, D, X
A is the safest
X is the riskiest
- Categories assigned by FDA based on risks of harm to the developing fetus
Drug Abuse and Dependence
lists the meds controlled substance classification (schedule), and the abuse and tolerance potential of the drug (if applicable)
Overdosage
lists the signs/symptoms and treatment options during and overdose situation
Product Description
lists the chemical name of med, a structural diagram of the med, active ingredients, and inactive ingredients
Clinical Pharmacology
contains information on how the medication works, and how the med is absorbed, metabolized, and eliminated from the body
Nonclinical Toxicology
lists any cancer and fertility risks from using the med
Clinical Studies
provides information from the clinical studies showing how well the drug words for its approved indications
How supplied
lists the med’s dosage forms, description by color, shape, and markings, and any special storage and handling instructions
Patient Counseling
highlights the most important counseling points about eh med for the pharmacist or prescriber
