Composition:

Each gram of Terbin cream contains 1.0% w/w of terbinafine HCl.

Each ml of Terbin topical solution contains 1.0% w/w of terbinafine HCl.

Pharmacodynamics:

Terbin, terbinafine HCl, is a synthetic allylamine derivative, which exerts its antifungal effect by inhibiting squalene epoxidase in the fungal cell membrane, a key enzyme in sterol biosynthesis in fungi.

This action results in a deficiency in ergosterol & a corresponding accumulation of squalene within the fungal cell causing fungal cell death.

At low concentrations terbinafine is fungicidal against dermatophytes, molds & certain dimorphic fungi.

The activity versus yeasts is fungicidal or fungistatic depending on the species.

Pharmacokinetics:

Less than 5% of the dose is absorbed after topical application to humans; systemic absorption is very low.

Therapeutic Indications:

Topical treatment of dermatological fungal infections such as interdigital tinea pedis (athlete’s foot), tinea cruris (jock itch) or tinea corporis (ringworm) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis & Epidermophyton floccosum.

Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans).

Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur).

Dosage and Administration:

Terbin can be applied once or twice daily.

Cleanse & dry the affected areas thoroughly before application of Terbin.

To be applied as directed to the affected skin & surrounding area. the likely durations of treatment are as follows:

Tinea corporis, cruris: 1 to 2 weeks.

Tinea pedis: 1 week.

Cutaneous candidiasis: 2 weeks.

Pityriasis Versicolor: 2 weeks.

Relief of clinical symptoms usually occurs within a few days.

Irregular use or premature discontinuation of treatment carries the risk of recurrence.

If there are no signs of improvement after 2 weeks, the diagnosis should be verified.

Precautions:

Diagnosis: Confirm diagnosis of the disease either by direct microscopic examination of scrapings from infected tissue mounted in a solution of potassium hydroxide or by culture.

For external use only: Not for oral, ophthalmic or intravaginal use. Pregnancy: There are no adequate & well controlled studies in pregnant women.

Lactation: Terbinafine is excreted in breast milk & therefore mothers should not use terbinafine whilst breast-feeding.

Children: Safety & efficacy in children <12 years of age have not been established.

Contraindications:

Hypersensitivity to terbinafine or any component of the product.

Adverse Reactions:

Redness, itching, or stinging; occasionally occur at the site of application; however, treatment has to be discontinued for this reason.

Presentation & Storage:

Terbin cream is supplied in tubes of 15 g each.

Terbin topical solution is supplied in glass bottles of 15 ml each.

Store at room temperature.