Naratriptan description

Naratriptan
NARATRIPTAN tablet® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Naratriptan
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Description

Naratriptan tablets, USP contain naratriptan as the hydrochloride, which is a selective 5-hydroxytryptamine1 receptor subtype agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:

The molecular formula is C17H25N3O2S•HCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is an off-white to pale yellow crystalline powder that is sparingly soluble in water.

Each naratriptan tablet for oral administration contains naratriptan hydrochloride equivalent to 1 mg or 2.5 mg of naratriptan, respectively. Each tablet also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, lactose monohydrate, hypromellose, titanium dioxide and triacetin. In addition the 2.5 mg tablet also contains iron oxide yellow and FD&C blue No.2 aluminum lake.

References

Adapted from the FDA Package Insert.