FORMULA:
1 g Fungofin Cream contains 10 mg Terbinafine Hydrochloride as active ingredient and benzyl alcohol as inactive ingredient

PHARMACOLOGICAL PROPERTIES:
Terbinafine is a synthetic allylamine antifungal agent which acts by inhibiting fungal squalene epoxidase, thus blocking the biosynthesis of ergosterol, an essential component of fungal cell membranes.Terbinafine’s fungucidal activity is provided by the toxic accumulation of squalene within the fungal cell wall. In vitro studies showed that dermatophyte squalene epoxidase enzyme is fourthousandfold more sensitive to terbinafine than mammalian squalene epoxidase.

INDICATIONS:

• Superficial fungal infections caused by Trichophyton strains T. rubrum and T. mentagrophytes, Microsporum canis and tinea pedis (athlete's foot), tinea cruris or tinea corporis due to Epidermophyton floccosum,
• Cutaneous yeast candidiasis caused by Candida (C. albicans),
• Pityriasis (tinea) versicolor caused by Pityrosporum orbiculare (Malassezia furfur).

SIDE EFFECTS / ADVERSE EVENTS:
Events associated with the use of topical terbinafine, stinging, itching, erythema and/or swelling have been reported in a small proportion of patients. These adverse events are usually well tolerated by the patients. These events should be distinguished from the hypersensitivity reactions which require cessation of the terbinafine treatment.

WARNINGS / PRECAUTIONS:
Mycofin Cream is intended for cutaneous use only, and should not be used intraoral, intranasal, intraophthalmic or intravaginally.

DOSAGE and ADMINISTRATION:
Fungofin Cream is applied once or twice daily depending on the indication. The duration of the treatment varies according to the indication and severity of the infection. Before the application, affected skin should be washed with soap and be dried completely. If the infection is in the intertriginous area (inframammarian, interdigital, intergluteal, inguinal area) affected skin may be covered with sponge.

Recommended duration of treatment:

Tinea corporis, cruris:	1-2 weeks
Tinea pedis:	1 week (twice a day), 2 weeks (once a day)
Cutaneous candidiasis:	1-2 weeks
Pityriasis versicolor:	2 weeks

Geriatric patients:
No dosage adjustment is necessary for elderly patients.

Pediatric patients:
In pediatric patients, clinical experience is limited.

HOW SUPPLIED:
Fungofin Cream is supplied in 15 g tubes.