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Basic Drug Info

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Drug Name:	Lamisil
Manufacturer:	Novartis Pharmaceuticals Corporation
Other Info:	Terbinafine hydrochloride is a synthetic allylamine derivative. Terbinafine hydrochloride is hypothesized to act by inhibiting squalene epoxidase, thus blocking the biosynthesis of ergosterol, an essential component of fungal cell membranes. In vitro, mammalian squalene epoxidase is only inhibited at higher (4000-fold) concentrations than is needed for inhibition of the dermatophyte enzyme. Depending on the concentration of the drug and the fungal species test in vitro, terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: Trichophyton mentagrophytes Trichophyton rubrum The following in vitro data are available, but their clinical significance is unknown. In vitro, terbinafine exhibits satisfactory MIC’s against most strains of the following microorganisms; however, the safety and efficacy of terbinafine in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials: Candida albicans Epidermophyton floccosum Scopulariopsis brevicaulis

Clinical Trials:	NIH - Clinical Trials

Indications and Usage

LAMISIL® (terbinafine hydrochloride) 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.

ONYCHOMYCOSIS -- A fungal infection of the nail plate, usually caused by a DERMATOPHYTES; YEASTS; or nondermatophyte MOLDS.

Contraindications

LAMISIL® (terbinafine hydrochloride) Tablets are contraindicated in individuals with hypersensitivity to terbinafine or to any other ingredients of the formulation.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of LAMISIL® (terbinafine hydrochloride) Tablets for the treatment of onychomycosis in individuals with and without pre-existing liver disease. In the majority of liver cases reported in association with LAMISIL® use, the patients had serious underlying systemic conditions and an uncertain causal association with LAMISIL®.

The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease (see PRECAUTIONS).

Treatment with LAMISIL® Tablets should be discontinued if biochemical or clinical evidence of liver injury develops (see PRECAUTIONS below).

There have been isolated reports of serious skin reactions (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis).

If progressive skin rash occurs, treatment with LAMISIL® should be discontinued.