Fungisafe [Terbinafine] – Oral & Topical Antifungal

Composition

• Tablets :Each tablet contains: Terbinafine hydrochloride 277 mg (Equivalent to 250 mg terbinafine base).
• Cream 1% – Each one gram contains Terbinafine hydrochloride 10 mg.

Properties

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.

Pharmacokinetic properties

Fungisafe Tablets

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.

Fungisafe Cream

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.

Indications

Fungisafe Tablets

1. Dermatophyte infections of skin & hair (tinea pedis, tinea corporis, tinea cruris and tinea capitis).
2. Dermatophyte infections of finger and toenails (onychomycosis).

Fungisafe Cream

Dermatophyte infections of the skin including:

1. Tinea pedis, tinea corporis, tinea cruris.
2. Pityriasis versicolor.
3. Cutaneous candidiasis.

Dosage

Fungisafe Tablets

• 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.

Fungisafe Cream

 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.

Patients information

• 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.

How Supplied

• 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