About PAM      PAM members       Consumers / Patient 

Home | Message BoardRegister | Search | Email us

Pharmaceutical Association of Mauritius

 

 

How to read a Prescription Drug Package Insert

Package insert styles vary from company to company but generally must include information under the section headings at the left and in the order listed. This website includes a brief description of each section's contents.
 

DESCRIPTION

Within this section, you will find the following general information:

  • generic (sometimes referred to as the scientific or chemical name) and brand names of the drug;
     
  • type of dosage form (i.e., capsules, tablets) and the route of administration (i.e., oral or intravenous);
     
  • pharmacological or therapeutic class (e.g., antibiotics) of the drug, and
     
  • chemical name and structural formula of the drug

If appropriate, other important chemical or physical information is included in this section.

INDICATIONS AND USAGE

This section contains information about the diagnosis or diagnoses that the drug has been formally approved to treat. However, sometimes drugs can be prescribed for various reasons other than the FDA-approved indications and many drugs have well-established secondary "off-label" uses. Ask your doctor, pharmacist, or other healthcare professional if you have questions about why a particular drug has been prescribed for you.

CONTRAINDICATIONS

Under this section heading, the labeling describes those situations in which the drug should not be used because the risk of use clearly outweighs any possible benefit. These situations include:

  • administration of the drug to patients known to have a hypersensitivity (excessively or abnormally sensitive reaction) to it;
     
  • use of the drug in patients who, because of their particular age, sex, concomitant therapy (i.e., another drug they are taking at the same time), disease state (e.g., diabetes), or other condition have a substantial risk if being harmed by it, or
     
  • continued use of the drug in the face of an unacceptably hazardous adverse reaction.

If no contraindications are known, this section of the labeling will state "None known."

 

WARNINGS

This section describes serious adverse reactions and potential safety hazards, limitations in use of the drug imposed by them, and steps that should be taken if they occur. Check with your pharmacist or the drug's manufacturer to make sure you are looking at the most current version of the package insert (PI). 

PRECAUTIONS

This section includes information about precautions for most individuals taking the drug, as well as specific groups such as pregnant women and nursing mothers and children.

The General precautions section includes information regarding any special care to be exercised by the healthcare practitioner for the safe and effective use of the drug.

The Information for Patients section contains information recommended to be given to patients by the doctor or other prescribing healthcare professionals to ensure safe and effective use of the drug. For example, this section may include precautions concerning driving when taking the medication, or the use of other substances (e.g., other drugs, food, alcohol) that may have harmful effects if taken while you are on this medication.

Within the Precautions section of the labeling, you will also find information about any laboratory tests that may be helpful in following patients' responses or in identifying possible adverse reactions to the drug, known interactions of the drug with other drugs or certain foods or ingredients, and known interference of the drug with laboratory tests. This section also includes information of interest if you are pregnant, thinking of becoming pregnant, or nursing.

If there is a specific pediatric indication (i.e., an indication for children from birth to 16 years, different from those approved for adults) it will be described under the Indications and Usage section, and appropriate pediatric dosage information will appear in the Dosage and Administration section
 

ADVERSE REACTIONS

An adverse reaction is an undesirable effect that may be associated with the use of the drug. Some adverse reactions are unexpected, may be serious, and are unpredictable. Causes of adverse reactions can include medication errors (e.g., overdosage), or interactions between different drugs or between drugs and certain foods.

This section of the labeling lists the adverse reactions that occur with the drug and with drugs in the same pharmacologically active and chemically related class (e.g., antibiotics, analgesics), if applicable.

DRUG ABUSE AND DEPENDENCE

Within this section of the package insert, information may appear if the drug is considered to have a potential for abuse, dependence, or withdrawal. Examples of drugs that may fall into this category are amphetamines and certain analgesics.

OVERDOSAGE

Under this section heading, the labeling describes the signs, symptoms, and laboratory findings associated with an overdosage of the drug, as well as complications that  can occur with the drug (e.g. organ toxicity).

DOSAGE AND ADMINISTRATION

This section states the recommended usual dose, the usual dosage range, and, if appropriate, an upper limit beyond which safety and effectiveness have not been established. This section also includes information about the intervals recommended between doses, the usual duration of treatment, and any modification of dosage needed in special patient populations (e.g., children, senior citizens, and patients with renal or hepatic disease).

HOW SUPPLIED

This section includes information on the available dosage forms to which the labeling applies and for which the manufacturer or distributor is responsible. This information generally includes:

  • Strength of the dosage forms (e.g., 10-milligram tablets)
     
  • Units in which the dosage form is ordinarily available for prescribers (e.g., bottles of 100)
     
  • Appropriate information to facilitate identification of the dosage forms (e.g., shape, color)
     
  • Special handling and storage conditions

 

ADDITIONAL SECTIONS

The labeling may also contain the following additional section headlines if appropriate and in compliance with federal regulations:

      ANIMAL PHARMACOLOGY

In most cases, the labeling need not include this section. Significant animal data necessary for safe and effective use of the drug in humans will ordinarily be included in one or more of the other sections of the labeling, as appropriate.

      CLINICAL STUDIES or REFERENCES

These sections may appear in labeling in the place of a detailed discussion of a subject that is of limited interest but nonetheless important. A reference to a specific important clinical study may appear in any section of the label if the study is essential to an understandable presentation of the available information.