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Reading a Package Insert
The Package Insert, also referred to as a “PI,” “Prescribing
Information” or “Labeling” is prepared by a medication’s
manufacturer for healthcare professionals who prescribe or dispense prescription
medicines. Your pharmacy should have a current Package Insert for any drug that
it dispenses. Reading the package insert cannot substitute for a discussion
with your doctor, pharmacist or other healthcare professional about any medication
you are about to take.
The Ortho-McNeil Neurologics, Inc., Web site offers current Package Inserts
for all of its products.
The U.S. Food and Drug Administration (FDA) requires prescription drug labeling
to contain specific information. Package Insert styles vary from company to
company, but generally they must include information under the following section
headings and in the order listed.
Description
This section of a PI contains the following general information:
- The generic name (sometimes referred to as the scientific or chemical name)
and the brand name of the drug
- Dosage form (for example, capsules, tablets, liquid) and the way it is
administered (for example, pill, shot, cream)
- Pharmacological or therapeutic class (for example, antibiotic, pain reliever,
antidepressant)
- Chemical name and structural formula of the drug
- Other important chemical or physical information, if appropriate
Clinical Pharmacology
Clinical pharmacology refers to the properties and actions of the drug or how
it works in the body. If the drug’s method of action is unknown or if
certain information is unavailable, the labeling will contain a statement to
that effect.
Indications and Usage
This section contains information about the treatment of the particular diagnosis
or diagnoses for which the FDA has approved the drug. However, drugs can sometimes
be prescribed for reasons other than the FDA-approved indications based on currently
available clinical data. Ask your doctor, pharmacist or other healthcare professional
if you have questions about why a particular drug has been prescribed for you.
Contraindications
The contraindications section describes situations in which the drug should
not be used because the risk of using it clearly outweighs the benefit. 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,
the limitations they impose on use of the drug, and steps that should be taken
if they occur. The FDA may require that notification of any special problems
associated with the drug be placed in a prominently displayed box called a “black
box.”
Precautions
This section of the PI includes precautions for most individuals taking the
drug, as well as for specific groups, such as pregnant women, nursing mothers
or children.
In this section, you will find recommendations for patients to ensure safe
and effective use of the drug. For example, there may be precautions about driving
when taking the medication or using substances such as other drugs, food or
alcohol that may have harmful effects if taken while using the medication.
The Precautions section also provides information about lab tests needed to
track responses or to identify adverse reactions to the drug or about known
interactions with other drugs, foods or ingredients.
Adverse Reactions
An adverse reaction is an undesirable effect that may be associated with use
of a drug. Causes of adverse reactions can include medication errors, such as
overdosage, or interactions between different drugs or between drugs and certain
foods. This section of the PI lists the adverse reactions that occur with the
drug and with other similar or related drugs, if applicable.
Drug Abuse and Dependence
Here you will find information if the drug is considered to have potential
for abuse, dependence or withdrawal. Examples of drugs that may fall into this
category are amphetamines and certain pain relievers.
Overdosage
This section describes the signs, symptoms and laboratory findings associated
with an overdosage of the drug, as well as complications that can occur with
it.
Dosage and Administration
This section states the usual recommended dose, the usual dosage range and,
if appropriate, an upper limit beyond which safety and effectiveness have not
been established. Also included in this section is information about the recommended
timing between doses, the usual duration of treatment and any modification of
dosage needed for special patient populations such as children or people with
particular diseases.
How Supplied
The How Supplied section has information on the dosage forms in which the medication
is available. This information generally includes:
- Strength of the dosage forms, such as 10-milligram tablets
- Units in which the dosage form is usually available for prescribers (for
example, bottles of 100)
- Information such as shape and color to help identify the dosage forms
- Special handling and storage conditions
Additional Sections
The labeling may also contain these additional section headings if appropriate
and in compliance with federal regulations:
- Animal pharmacology. In most cases, the labeling does not need to include
this section. Significant animal data necessary for safe and effective use of
the drug in humans will usually be included in one or more of the other sections
of the labeling.
- Clinical studies or references. A reference to an important clinical
study may appear in any section of the label.
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