Full Prescribing Information Sections

Indications and Usage: Describes the approved uses of the medication, including specific conditions or diseases it is intended to treat.

Dosage and Administration: Provides detailed instructions on how to use the medication safely and effectively, including dosage forms, strengths, and administration routes.

Dosage Forms and Strengths: Lists the available forms (e.g., tablets, capsules, injections) and the strengths of the medication that are commercially available.

Contraindications: Outlines situations where the medication should not be used due to potential harm or ineffectiveness.

Warnings and Precautions: Includes important safety information, potential risks, and precautions that healthcare providers should be aware of when prescribing or administering the medication.

Adverse Reactions: Summarizes the most common and/or serious adverse effects reported during clinical trials or post-marketing surveillance.

Drug Interactions: Lists known interactions with other medications, foods, or substances that may affect the efficacy or safety of the medication.

Use in Specific Populations: Provides information about the medication’s use in special populations such as pregnant or nursing women, pediatric patients, and elderly patients.

Drug Abuse and Dependence: Describes any potential for abuse, dependence, or withdrawal symptoms associated with the medication, if applicable.

Overdosage: Gives guidance on the management of overdose situations, including symptoms and treatment options.

Description: Provides a brief overview of the drug’s pharmacology, including its mechanism of action and chemical structure.

Clinical Pharmacology: Offers detailed information about the pharmacokinetics (absorption, distribution, metabolism, excretion) and pharmacodynamics (effects and mechanisms of action) of the medication.

Nonclinical Toxicology: Summarizes nonclinical (animal) studies evaluating potential toxic effects that may occur with the medication.

Clinical Studies: Presents summaries of clinical trials that were conducted to support the medication’s approval, including efficacy and safety results.

References: Lists the primary literature sources and studies cited throughout the prescribing information.

How Supplied/Storage and Handling: Provides information on how the medication is packaged, stored, and handled prior to dispensing to patients.

Patient Counseling Information: Includes instructions and important information that healthcare providers should discuss with patients regarding the safe use of the medication.

FDA Approval History: Details the regulatory history of the medication, including approval dates, changes in labeling, and any post-marketing requirements.