- Tablets :Each tablet contains: Terbinafine hydrochloride 277 mg (Equivalent to 250 mg terbinafine base).
- Cream 1% – Each one gram contains Terbinafine hydrochloride 10 mg.
Terbinafine HCl (Fungisafe®) is a synthetic allylamine derivative that exerts its antifungal effect by inhibiting squalene epoxidase, a key enzyme in sterol biosynthesis in fungi. This action results in a deficiency in ergosterol and a corresponding accumulation of squalene within the fungal cell causing fungal cell death.
It is fungicidal against dermatophytes (Trichophyton spp., Microsporum spp. & Epidermophyton spp.), mold fungi & some yeasts.
Terbinafine HCl (Fungisafe®) is well absorbed from the gastro-intestinal tract.
Bioavailability is 80% and is not affected by the presence of food. Mean peak plasma concentrations of about 1ug/ml are reported within 2 hours of a single oral dose of 250 mg.
Terbinafine is extensively bound to plasma proteins (99%).
Fungisafe® is distributed into the stratum corneum of the skin, the nail plate & hair where it reaches concentrations considerably higher than those found in plasma.
Terbinafine (Fungisafe®) is metabolised in the liver to inactive metabolites.
Approximately 80% of an administered dose is excreted in the urine as metabolites and the remainder in feces.
A plasma elimination half-life varying from 11-17 hours has been reported and a terminal elimination half-life of up to 400 hours in patients receiving prolonged therapy, probably representing elimination from skin & adipose tissue.
The elimination rate may be altered in patients with liver or kidney diseases.
Less than 5% of the topically applied terbinafine cream is absorbed.
The elimination half-life of topically absorbed terbinafine is 21 hours.
Approximately 75% of topically absorbed.
- Dermatophyte infections of skin & hair (tinea pedis, tinea corporis, tinea cruris and tinea capitis).
- Dermatophyte infections of finger and toenails (onychomycosis).
Dermatophyte infections of the skin including:
- Tinea pedis, tinea corporis, tinea cruris.
- Pityriasis versicolor.
- Cutaneous candidiasis.
- For onychomycosis: The usual oral dose is one tablet (250 mg) once daily for 6 weeks (fingernails) and for 12 weeks (toenails).
- For dermatophytes of the skin: The usual oral dose is one tablet (250 mg) once daily for 2-4 weeks in tinea corporis and tinea cruris &for 2-6 weeks in tinea pedis.
- For tinea capitis: the dose is one tablet (250 mg) once daily for 4 weeks.
Patients with renal impairment (creatinine clearance < 50 ml/min) or patients with pre-existing stable chronic liver disease, should receive half the usual dose of terbinafine.
Fungisafe tablets for Children:
- No data are available in children under two years of age (usually < 12 kg).
- < 20 kg body weight: 62.5 mg daily.
- 20-40 kg: 125 mg daily.
- 40 kg: 250 mg daily.
Tinea pedis: Between the toes only: apply twice daily for 1 week. On the bottom or sides of the foot: apply twice daily for 2 weeks.
Tinea corporis , tinea cruris: apply once or twice daily for 1-2 weeks.
Pityriasis versicolor & cutaneous candidiasis: apply once or twice daily for 2 weeks.
- Use the tip of the cap to break the seal & open the tube.
- Wash the affected skin with soap & water and dry completely before application of cream.
- Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly.
- Wash hands after each use.
- Tablets: Strips of 7 tablets in packs of one strip.
- Cream: Tubes of 15 gm.
Keep all medicaments out of reach of children
Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: D01BA02