Fungisafe Tablets

Composition: Tablets:
Each tablet contains: Terbinafine Hydrochloride 277mg.  Equivalent to 250mg Terbinafine base.

Cream 1%:
Each one gram contains: Terbinafine Hydrochloride 10mg.

Properties: Pharmacological Properties:
Pharmacodynamic Properties:
Terbinafine HCl (Fungisafe^®) is a synthetic allylamine derivative that exerts its anti-fungal 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. and Epidermophyton spp.), mold fungi and some yeasts.

Pharmacokinetic Properties:
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 250mg.
-    Terbinafine is extensively bound to plasma proteins (99%).
-    Fungisafe^® is distributed into the stratum corneum of the skin, the nail plate and hair where it reaches concentrations considerably higher than those found in plasma.
-    Terbinafine (Fungisafe^®) is metabolized 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.

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 Terbinafine is eliminated in the urine, mostly as inactive metabolites.

Indications: Tablets:
-    Dermatophyte infections of skin and hair (tinea pedis, tinea corporis, tinea cruris and tinea capitis).
-    Dermatophyte infections of finger and toenails (onychomycosis).

Cream
-    Dermatophyte infections of the skin including:
-    Tinea pedis, tinea corporis, tinea cruris.
-    Pityriasis versicolor
-    Cutaneous candidiasis

Contra-Indictions: -    Hypersensitivity to Terbinafine HCl.
-    Patients sensitive to the oral form of Terbinafine may be sensitive to the topical form also.

Adverse Effects:Tablets:
-    The most frequent adverse effects following oral administration of Terbinafine Hydrochloride are gastro-intestinal disturbances such as nausea, diarrhea, anorexia and mild abdominal pain.  Also headaches and skin reactions including rash or urticaria.
-    Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have occurred rarely. Taste disturbances, photosensitivity and rarely liver toxicity including jaundice, cholestasis and hepatitis also reported.
-    Neutropenia & agranulocytosis have been reported rarely.

Cream:
-    Redness and stinging or pruritus may occur at the site of application, but rarely require treatment discontinuation. Drug interactions
-    Plasma concentrations of Terbinafine may be increased by drugs that inhibit its metabolism by Cytochrome P450, such as cimetidine, and decreased by drugs that induce Cytochrome P450 such as Rifampicin.

Dosage & Administration: Tablets:
-    For onychomycosis: The usual oral dose is one tablet (250mg) once daily for 6 weeks (fingernails) and for 12 weeks (toenails)
-    For dermatophytes of the skin:  The usual oral dose is one tablet (250mg) once daily for 2-4 weeks in tinea corporis and tinea cruris and for 2-6 weeks in tinea pedis.
-    For tinea capitis the dose is one tablet (250mg) once daily for 4 weeks.

For Children:
-    No data are available in children under two years of age (usually <12kg).
-    <20 kg body weight: 62.5mg daily.
-    20-40 kg: 125mg daily.
-    >40 kg: 250mg daily.


-    Patients with renal impairment (creatinine clearance <50ml/min) or patients with pre-existing stable chronic liver disease should receive half the usual dose of Terbinafine.

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 and tinea cruris: Apply once or twice daily for 1-2 weeks.
-    Pityriasis versicolor and cutaneous candidiasis: Apply once or twice daily for 2 weeks.

Patient's Information:
-    Use the tip of the cap to break the seal and open the tube.
-    Wash the affected skin with soap and 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 15gm.

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