Terbinafine Hydrochloride is (E)-N-(6,6-dimethyl-2-heptane-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The empirical formula of Terbinafine Hydrochloride is C21H26CIN and its molecular weight is 327.90. 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.
MICROBIOLOGY:
Terbinafine Hydrochloride (Funge), an Allylamine antifungal, inhibits biosynthesis of Ergosterol, an essential component of the fungal cell membrane, via inhibition of the Squalene epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of Squalene but not due to Ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, Terbinafine Hydrochloride (Funge) may be fungicidal. Terbinafine Hydrochloride (Funge) has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections:-

• Trichophyton mentagrophytes
• Trichophyton rubrum

PRECAUTIONS:
Terbinafine Hydrochloride (Funge) Tablets are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine Hydrochloride (Funge) tablets preexisting liver disease should be assessed. Hepatotoxicity may occur in patients with or without preexisting liver disease. Patients prescribed Terbinafine Hydrochloride (Funge) tablets should be warned to report immediately any symptom of unexplained persistent nausea, anorexia, fatigue, vomiting, right abdominal pain, jaundice, dark urine or pale stools.
Patients with these symptoms should discontinue taking oral Terbinafine Hydrochloride (Funge) tablets and the patient’s liver function should be immediately evaluated.
Patients with impaired renal function (Creatinine clearance less than 50ml/min or serum creatinine of more than 300micro mol/L) should receive the half dose.
DRUG-DRUG INTERACTION:
Co-administration of a single dose of fluconazole (100mg) with a single dose of Terbinafine Hydrochloride (Funge) resulted in a 52% and 69% increase in Terbinafine Cmax and AUC.
Fluconazole is an inhibitor of CYP2C9 and CYP3A enzymes. Based on this finding, it is likely that other inhibitors of both CYP2C9 and CYP3A4 (e.g. Ketoconazole, Amiodarone) may also lead to a substantial increase in the systemic exposure (Cmax and AUC) of Terbinafine when concomitantly administered.
Terbinafine clearance is increased 100% by Rifampin and decreased 33% by Cimetidine. Terbinafine clearance is unaffected by Cyclosporine
An evaluation of the effect of food on Terbinafine Hydrochloride (Funge) Tablets was conducted. An increase of less than 20% of the AUC of Terbinafine was observed when Terbinafine Hydrochloride (Funge) Tablets were administered with food.
INSTRUCTIONS:
Store in a cool & dry place below 25ºC.
Protect from light, heat and moisture.
Keep out of reach of children.