Terbisil Cream

COMPOSITION:

Terbinafine Hydrochloride BP ………….1% w/w

Benzyl Alcohol BP…………………………….1 % w/W

(As preservative)

Cream base……………………………………..q.S.

FOR EXTERNAL USE ONLY MECHANISM OF ACTION:

Terbinafine is an allylamine that has a broad spectrum of antifungal activity. At low concentrations Terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase In the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P-450 system. Terbinafine does not influence the metabolism of hormones or other drugs.

INDICATIONS:

Terbisil Cream is used in the treatment of Athlete’s foot (Tinea pedis), Dhobie itch/jock itch (tinea cruis), Ringworm (tinea corporis), Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans) and Pityriasis (tinea) versicolor due to Pityrosporum orbiculare.

POSOLOGY AND METHOD OF ADMINISTRATION:

Adults and children over 12 years of age:

Terbisil Cream is applied once daily.

Duration and frequency of treatment

The likely duration of treatment are as follows:

Tinea pedis:

Once a day for 1 week

Tinea corporis, cruris:

Once a day for 1 week

Cutaneous candidiasis:

Once or twice a day for 1 to 2 weeks

Pityriasis versicolor:

Once or twice a day for 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 two weeks the diagnosis should be verified.

Dosing in special populations:

Paediatric population

The experience with topical Terbisil Cream in children is still limited and its use in children under 12 years cannot therefore be recomended.

Elderly patients

There is no evidence that elderly patients require different dosages or

experience side-effects ditterent to those of younger patients.

CONTRA INDICATIONS:

There are no known contraindication except Hypersensitivity to Terbinafine Hydrochloride.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE:

Terbisil Cream is for external use only.

Should be used with caution in patients with lesions where alcohol could be irritating.

Should be kept out of the reach and sight of children.

UNDESIRABLE EFFECTS:

Local symptoms such as pruritis, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema and scab may occur at the site of application. These minor symptoms must be distinguished from hypersensitivity reactions such as widespread pruritis, rash, bullous eruptions and hives, which are reported in sporadic cases but require discontinuation. In case of accidental contact with the eyes, terbinafine hydrochloride may be irritating to the eyes. In rare cases the underlying fungal infection may be aggravated.

OVERDOSAGE:

The low systemic absorption of topical terbinafine renders overdosage extremely unlikely.

STORAGE:

Store below 30°C. Protect from light. Do not refrigerate.

KEEP MEDICINE OUT OF REACH OF CHILDREN.

PRESENTATION:

Each carton contains one tube of 15 g.