Generic Lamisil

For the use only ot a Registered Medical Practitioner or a Hospital or a Laboratory.
Terbinafine Tablets 250 mg FUNGOTEK

COMPOSITION
Each uncoated tablet contains Terbinafine Hydrochloride equivalent to Terbinafine................................250 mg

DESCRIPTION
Terbinafine Hydrochloride is a synthetic allylamine antifungal agent. Terbinafine, which is a potent and broad spectrum anti-fungal agent is derived from naphthalenemethanamine and is structurally and pharmacologically related to naftifine.

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Terbinafine acts by inhibition of squalene epoxidation, an earlier stage in the ergosterol pathway by inhibiting squalene epoxidase. This results in decreased ergosterol and increased squalene content in fungal cells. Both of these effects appear to contribute to the antifungal action of Terbinafine.
Mammalian squalene epoxidase appears to be markedly less sensitive than the fungal enzyme to inhibition by Terbinafine The selective and specific action of Terbinafine on fungal squalene epoxidase suggests that mechanism-based adverse effects in humans are unlikely.
In, in vitro studies Terbinafine has demonstrated activity against a wide range of dermatophytes, filamentous, dimorphic and dematiaceous fungi, as well as yeasts. It is fungicidal against dermatophytes, Aspergillus species. Blastomyces dermatitidis, Histoplasma capsulatum and Candida parapsilosis. It is fungistatic against C albicans.

Pharmacokinetic Properties
Terbinafine Hydrochloride is well absorbed from the gastrointestinal tract. Mean peak plasma concentrations of 0.97 meg per ml, following a single oral dose of 250 mg are reached within 2 hours of administration. Steady state concentrations are reached in 10 to 14 days.
Terbinafine distributes preferentially into tissues including skin, sebum, nail plate and hair.
Terbinafine is metabolized in liver to inactive metabolites which are excreted in urine. An elimination half life of 17 hours has been reported.

INDICATIONS
1. Dermatophyte infections of the skin and hair caused by Trichophyton spp., Microsporum spp. or Epidermophyton spp. species such as tinea corporis, tinea cruris, tinea pedis and tinea capitis
2. Dermatophyte infections of fingernails and toenails. DOSAGE & ADMINISTRATION
Children : The data regarding safety experience with oral Terbinafine in children is still limited. However, in children it has been tried in following dosages :

Children (2 yrs and above) : up to 20 kg body weight - 62.5 mg once a day 20-40 kg body weight - 125 mg once a day above 40 kg body weight- 250 mg once a day
Adults: 250 mg once a day
Terbinafine is given once daily by mouth for 2-4 weeks for treatment of tinea pedis / manuum / capitis / cruris/corporis or cutaneous candidiasis; treatment may have to be continued for 6 weeks for tinea pedis infections.
Dermatophyte infections of the finger and toe nails are treated with Terbinafine by mouth once daily for 6 weeks to 4 months, although some patients (particularly those with toenail infections) may require treatment for up to 12 months.
Administration In hepatic and renal Impairment : Patients with chronic stable liver dysfunction or with renal dysfunction (creatinine clearance of less than 50 ml per minute or serum creatinine concentration of more than 300 m mol per litre) should receive half the usual dose of TERBINAFINE.

CONTRAINDICATIONS
Pregnancy, lactation and hypersensitivity to any ingredient in the preparation.

PRECAUTIONS
Use with caution in patients with hepatic or renal dysfunction and reduce dosage if severe

WARNING
SEVERE HEPATOTOXICITY HAS BEEN REPORTED IN A FEW PATIENTS TREATED WITH TERBINAFINE.

DRUG INTERACTIONS
Terbinafine has little or no effect on cytocrome P450 mixed function oxidase system. But it is a type 1 substrate for a small portion of the P450 system of liver microsomes. Clearance of caffeine is decreased in presence of Terbinafine. Drugs that induce or inhibit microsomal enzymes such as Rifampin or Cimetidine respectively may interfere with the metabolism of Terbinafine. Cautious use of Terbinafine is advised in women on oral contraceptives, since some cases of menstrual disturbance (break-through bleeding and irregular cycles) have been reported in patients taking Terbinafine concomitantly with oral contraceptives.

ADVERSE REACTIONS
The most frequent adverse effects following oral administration of Terbinafine are gastrointestinal disturbances such as nausea, diarrhoea, anorexia and mild abdominal pain and skin reactions including rash or urticaria. Loss of taste and liver dysfunction have been reported.
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