Drug Catalog - Product Detail
TERBINAFINE HCL TB 250MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 67405-0500-03 | HARRIS PHARMACEUTICAL | 30 | 250MG | TABLET |
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Description
11 DESCRIPTION Terbinafine tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride. Chemically, terbinafine hydrochloride is (E)- N -(6, 6-dimethyl-2-hepten-4-ynyl)- N -methyl-1-naphthalenemethanamine hydrochloride. The empirical formula C 21 H 26 ClN with a molecular weight of 327.90, and the following structural formula: Terbinafine hydrochloride 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 Ingredients: terbinafine hydrochloride (equivalent to 250 mg base) Inactive Ingredients: colloidal silicon dioxide NF, hypromellose USP, magnesium stearate NF, microcrystalline cellulose NF, and sodium starch glycolate NF. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Terbinafine tablets, USP 250 mg are supplied as white, circular biconvex tablets debossed with "C134" on one side and plain on the other side. Bottles of 30 tablets NDC 67405-500-03 Bottles of 100 tablets NDC 67405-500-10 Store Terbinafine tablets, USP at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]; in a tight container. Protect from light.
Indications & Usage
1 INDICATIONS AND USAGE Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Prior to administering, evaluate patients for evidence of chronic or active liver disease. ( 2.1 ) Fingernail onychomycosis: One tablet, once daily for 6 weeks. ( 2.2 ) Toenail onychomycosis: One tablet, once daily for 12 weeks. ( 2.2 ) 2.1 Assessment Prior to Initiation Before administering terbinafine tablets, evaluate patients for evidence of chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1) ]. 2.2 Dosage Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks. Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.