Terbinafine description

Terbinafine
LamISIL®,FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]

DESCRIPTION

Terbinafine tablets, USP contain the synthetic allylamine antifungal compound terbinafine hydrochloride USP.

Chemically, terbinafine hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The molecular formula C21H26ClN with a molecular weight of 327.90, and the following structural formula:

Terbinafine hydrochloride USP is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.

Each tablet contains:

Active Ingredient: Terbinafine hydrochloride USP (equivalent to 250 mg of terbinafine)

Inactive Ingredients: Microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, hypromellose, and magnesium stearate.

References

Adapted from the FDA Package Insert.