How to Read a Package Insert
October 22, 2015
Table of Contents
When you are starting or thinking of starting a new HIV drug, your health care provider will discuss some basic information with you. When you get the prescription filled, you usually receive additional written information. This may be just a brief summary provided by the pharmacy, or you may receive a very detailed "package insert" filled with information provided by the drug manufacturer and approved by the US Food and Drug Administration (FDA).
Each country or region has its own agency that regulates drugs and provides the information that consumers receive with their prescriptions. In India, it is the Central Drugs Standard Control Organization (CDSCO), which is commonly referred to as the Drugs Controller General (DCG). In Europe, it is the European Medicines Agency (EMA), where the package insert is known as the patient information leaflet (PIL).
Package inserts (also known as Prescribing Information or drug labels) are available for all prescription medications approved by the FDA. Similar information is available for nonprescription medicines and for some herbal medicines and dietary supplements as well.
The package insert can usually be found online on the drug manufacturer's web site and is also available in a reference book called the Physicians' Desk Reference (PDR), which you may be able to find at your local library. You can also access the PDR online at PDR.net.
The information in a package insert is written in technical language. It is usually very long and can be difficult to understand. It is a good idea to look through it, because it lists important information about the drug. If you have any questions, ask your health care provider or pharmacist. You can also ask an educator at your local AIDS service organization.
The package insert follows a standard format for every drug. After some identifying information such as the drug's brand name, generic name, and initial year of FDA approval, the following sections appear:
Package inserts for some HIV drugs begin with "Boxed Warnings," which highlight especially serious (often life-threatening) side effects that have been reported but are rare.
The package insert will most often use the generic name of the drug. Patients usually know a drug by its brand name, so this can be confusing. Please refer to our HIV Drug Chart/Overview, which lists each drug by brand and generic names if you have questions. A quick search online using whatever name you have should also bring up the drug's other names (e.g., if what you have is the generic name, most websites that mention that drug will also list its brand name and possible abbreviations).
Here is what you can expect to find in each section:
This first section is a brief summary of the information that is the most important for readers to know. It refers readers to the appropriate section(s) in the package insert for additional, more detailed information.
This section lists the uses (indications) for which the drug has been FDA-approved. All HIV drugs are indicated for use in combination with other approved HIV drugs, unless the HIV drug is already a combination pill (e.g., Atripla). This section will also state if the drug can be used by patients who have taken HIV drugs before, by patients who have never taken HIV drugs, or by both. It may say what class of drug this is and what other HIV drugs should or should not be taken with it. A detailed description of the clinical studies for this drug will follow and will often include graphs and charts.
This section gives the recommended dosages (doses) of the medicine and may advise if the drug should be taken with or without food. If the medicine is indicated for more than one use (e.g., to treat HIV and hepatitis B), you may see separate sections for each use. Separate information also may be given about dosages for women above and below a certain weight, children, older people, or those with certain medical problems.
This section describes the drug's color and form (e.g., capsule, ointment). It also lists the strength or amount of medication in that form. Several different strengths and form descriptions may be listed for the same drug.
This section describes situations when the drug should be used with caution or not at all. These are called contraindications. For instance, a medicine should not be prescribed for someone who has had an allergic reaction (hypersensitivity) to the same medication or one that is similar, or for someone who is taking another medicine that interacts with it in a harmful way.
This section also may warn health care providers not to prescribe the medicine for people with certain medical conditions because they are at greater risk of dangerous side effects. If you have a serious medical condition, this is the place to find out whether it is likely to cause a problem if you take this medicine.
This article was provided by The Well Project. Visit The Well Project's Web site to learn more about their resources and initiatives for women living with HIV. The Well Project shares its content with TheBody.com to ensure all people have access to the highest quality treatment information available. The Well Project receives no advertising revenue from TheBody.com or the advertisers on this site. No advertiser on this site has any editorial input into The Well Project's content.
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