LAMISIL®(terbinafine hydrochloride tablets) Tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium) (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES).

Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.

LAMISIL® (terbinafine hydrochloride tablets) Tablets, one 250 mg tablet, should be taken once daily for 6 weeks by patients with fingernail onychomycosis. LAMISIL®, one 250 mg tablet, should be taken once daily for 12 weeks by patients with toenail onychomycosis. 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.

LAMISIL®
(terbinafine hydrochloride tablets)

Tablets

Supplied as white to yellow-tinged white circular, bi-convex, bevelled tablets containing 250 mg of terbinafine imprinted with “LAMISIL” in circular form on one side and code “250” on the other.

Bottles of 100 tablets......... NDC 0078-0179-05

Bottles of 30 tablets.......... NDC 0078-0179-15

Store tablets below 25 °C (77 °F); in a tight container. Protect from light.

Manufactured by: Patheon Whitby Inc. Whitby, Ontario, Canada L1N 5Z5. Distributed by: Novartis Pharmaceuticals Corporation., East Hanover, New Jersey 07936. REV: January 2004. FDA Rev date: 1/21/2004

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