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Basic Drug Info
Drug Name:Terbinafine Hydrochloride
Manufacturer:Roxane
Other Info:

A wide range of in vivo studies in mice, rats, dogs, and monkeys, and in vitro studies using rat, monkey, and human hepatocytes suggest that peroxisome proliferation in the liver is a rat-specific finding.

However, other effects, including increased liver weights and APTT, occurred in dogs and monkeys at doses giving Css trough levels of the parent terbinafine 2 to 3x those seen in humans at the MRHD.

Higher doses were not tested.10003513/02 Revised February 2008 © RLI, 2008



Clinical Trials:


Indications and Usage
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
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 terbinafine for the treatment of onychomycosis in individuals with and without pre-existing liver disease.In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine.

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

Treatment with terbinafine 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 terbinafine should be discontinued.
Branded Drugs
The following US Branded drugs contain Terbinafine Hydrochloride


LAMISIL -- NOVARTIS PHARMACEUTICALS CORP

LAMISIL -- NOVARTIS CONSUMER HEALTH INC

LAMISIL AT -- NOVARTIS CONSUMER HEALTH INC


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