Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of 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 terbinafine hydrochloride use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine hydrochloride. 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 Hydrochloride 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 terbinafine hydrochloride should be discontinued.
There is currently no manufacturer warning information available for this drug.
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.
Terbinex™ Terbinafine Hydrochloride 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 C21H26ClN 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; sodium starch glycolate, NF