BET-CL 10 gm Ointment

BET-CL 10 gm Ointment

DESCRIPTION

Clotrimazole is a broad-spectrum antifungal agent used for the treatment of superficial infections caused by species of pathogenic dermatophytes and yeasts. It exerts its action by inhibiting the synthesis of ergosterol, a major sterol in the fungal cell membrane, which leads to instability of the cell membrane that eventually causes death of the fungus. Betamethasone Valerate is a corticosteroid having the anti-inflammatory, antipruritic, and vasoconstrictive properties. But the exact mechanism of action of corticosteroids is not clearly known.

COMPOSITION

BET-CL Ointment : Each gram ointment contains Betamethasone (as Valerate ) BP 1 mg and Clotrimazole BP 10 mg.

INDICATIONS

BET-CL ointment is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis etc.

DOSAGE AND ADMINISTRATION

Sufficient amount of BET-CL ointment should be applied onto the affected and surrounding skin areas twice a day, in the morning and evening, for 2 weeks in tinea cruris and tinea corporis and for 4 weeks in tinea pedis. The use of BET-CL ointment for longer than four weeks is not recommended.

SIDE EFFECTS

Adverse reactions reported for the preparation in clinical trials were paresthesia in 1.9% of patients; rash, edema and secondary infection, each in less than 1% of patients. Other adverse reactions reported with the preparation were burning and dry skin in 1.6% of patients and stinging in less than 1% of patients.

CONTRAINDICATION

The preparation is contraindicated to those patients who are sensitive to Clotrimazole, Betamethasone, other corticosteroids or imidazoles or to any of the ingredients of the product. If irritation or sensitization develops with the use of the ointment, treatment should be discontinued and appropriate therapy instituted. The ointment is also contraindicated in facial rosacea, acne vulgaris, perioral dermatits, perianal and genital pruritus, napkin eruptions and bacterial or viral infections.

PRECAUTION

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. If HPA axis suppression noted, an attempt should be made to withdraw the drug or to reduce the frequencey of application. Manifestations of Cushing's syndrome, hyperglycemia and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

USE IN PREGNANCY & LACTATION

There is no adequate evidence of safety in pregnancy. Clotrimazole has no teratogenic effect in animals, but is foetotoxic at high oral doses. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. Hence the ointment should only be used in pregnancy, if the benefit justifies the potential risk to the fetus and such use should not be extensive. It is not known whether the components of the preparation are excreted in human milk and therefore caution should be exercised when treating nursing mothers.

USE IN CHILDREN

The safety and effectiveness of this preparation has not been established in children below the age of 12 years.

DRUG INTERACTION

Information is not available.

OVER DOSE

Acute overdose with the ointment is unlikely and would not be expected to lead to a life-threatening situation. The ointment should not be used for longer than the prescribed time period.

SUPPLY

BET-CL Ointment : Each pack contains 10 g ointment in a tube