DRUG INTERNATIONAL LTD.
BETAMETHASONE + CLOTRIMAZOLE
This cream is indicated for the topical treatment of inflammatory dermal infections like tinea pedis, tinea cruris, tinea corporis etc.
Betamethasone & Combined preparations
Clotrimazole is a broad-spectrum antifungal agent used for the treatment of superficial infections caused by species of pathogenic dermatophytes, yeasts and Malassezia furfur. The mechanism of action involves inhibition of the synthesis of ergosterol, a major sterol in the fungal cell membrane. This leads to instability of the cell membrane and eventual death of the fungus. Betamethasone dipropionate is a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. But the exact mechanism of action of corticosteroids is not clearly known.
Sufficient cream or 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 cream for longer than four weeks is not recommended.
No information is available.
The preparation is contraindicated to those patients who are sensitive to any of its components or to other corticosteroids or to imidazoles. The cream is contraindicated in facial rosacea, acne vulgaris, perioral dermatits, perianal and genital pruritus, napkin eruptions and bacterial or viral infections.
Clotrimazole is well tolerated when applied topically. Local irritation and burning sensation may occur in a very few cases but these symptoms are not considered harmful. Contact allergic dermatitis has been reported, if this occurs, treatment should be discontinued.
Pregnancy: Catagory C. In the first trimester of pregnancy, clotrimazole should be used only when it is essential for the welfare of the patient. Administration of clotrimazole to a small number of women in the 2nd and 3rd trimesters of pregnancy has produced no obvious untoward effect on the course of the pregnancy or on the fetus. Lactation: Although systemic absorption following topical or vaginal administration is low, caution should be exercised when clotrimazole is administered to nursing mothers as there is no information on whether or not clotrimazole is excreted in breast milk.
Acute overdose with the cream is unlikely and would not be expected to lead to a life-threatening situation. The cream should not be used for longer than the prescribed time period.
Not recommended for use in diaper dermatitis and under occlusion. Pregnancy and lactation. If irritation or sensitization develops with the use of the cream, treatment should be discontinued and appropriate therapy instituted
Store at or below 308C. Do not freeze.