Terbinex
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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
Sources
Terbinex Manufacturers
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Innocutis
![Terbinex (Terbinafine Hydrochloride ) Tablet [Innocutis]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Terbinex | Innocutis
Terbinafine Hydrochloride Tablets, one 250 mg tablet, should be taken once daily for 6 weeks by patients with fingernail onychomycosis. Terbinafine hydrochloride, 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.
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