Capital Cardiology Associates
Making Sense of Medication Package Inserts
The “fine print” on how a drug works
It is not unusual to pick up a prescription and receive a very long and detailed medication package insert. After realizing how wordy and small the font is, you want to decide what the most important sections to read are.
Medication package inserts contain comprehensive information approved by the U.S. Food and Drug Administration (FDA) based on research/clinical trials in which the medication is taken by patients. Package inserts contain in-depth clinical evidence which is often difficult for patients to interpret and laborious for healthcare professionals to read through. Patients often ask questions regarding information they heard about a medication in a TV commercial; this information comes straight from a package insert.
In the chart below, common sections found in package inserts are listed. There are many other sections found in package inserts, but some of the most important are explained below. If you have any questions after reading a package insert, feel free to contact the Capital Cardiology Associates pharmacist.
Indications and Usage:
This section lists the FDA approved indications for the medication. It is important to know that a doctor may prescribe medications for an indication not approved by the FDA or an “off-label” usage; this does not mean the medication is being used inappropriately. Before providing a patient with drug information, it is very important to know why they are taking the medication.
Dosage and Administration:
This section explains the FDA recommended dosages of the medication and how to take the medication. This section can be very important to find if a patient should take the medication with or without food, what time of the day to take their dose, etc. It is very important to know that sometimes different dosages are recommended based on a patient’s health problems or other medications they are also taking. Some medications may need reduced dosing based on a patient’s liver or kidney function because of the way medications are metabolized (broken-down/processed in the body) or eliminated from the body.
This section lists ALL side effects that were reported while the medication was being studied in clinical trials, including uncommon side effects. Many patients may read this section and be hesitant to use a medication because of the side effects listed. Often the percent of patients that the side effect occurred in is listed. Usually, the benefit of using the medication outweighs the risk of having a side effect.
This section lists situations in which the medication should not be used. For example, there are certain medical conditions that may put a patient at higher risk for dangerous side effects if they use the medication.
This section is often hard to interpret. Depending on the drug interaction, there may be different recommendations for monitoring, dose reductions, discontinuation of concomitant medications, etc. If you have any questions regarding a drug interaction, please contact Dr. Kate Cabral, Capital Cardiology’s Clinical Pharmacist for a consultation.
Other information you may find in a package insert: proper medication storage, clinical trial data, use in special populations (pregnancy or lactation, elderly people, children, etc.), black box warnings (important safety information that explains a serious hazard/risk associated with the drug), and dosage strength/forms (tablet, capsule, liquid, etc.) the medication comes in. Lastly, at the end of the package insert, there is often a patient education guide that is written in patient friendly terms that may be provided to help answer common questions.
Written by: Katie Parsels, Albany College of Pharmacy and Health Sciences Intern at Capital Cardiology Associates
Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional.