Generics: Betamethasone + Clotrimazole
Dosage Form: Ointment.
This topical preparation is indicated for the topical treatment of inflammatory dermal infections like-
- Tinea pedis
- Tinea cruris
- Tinea corporis etc.
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.
Twice daily. Sufficient topical preparation 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 this cream for longer than four weeks is not recommended.
The safety and effectiveness of the preparation have not been established in children below the age of 12 years.
Route of administration: Topically.
No information is available of drug interaction.
This topical preparation is contraindicated to those patients who are sensitive to any of its components or to other corticosteroids or to imidazoles. If irritation or sensitization develops with the use of the cream, treatment should be discontinued and appropriate therapy instituted. The cream is contraindicated in facial rosacea, acne vulgaris, perioral dermatits, perianal and genital pruritus, napkin eruptions and bacterial or viral infections. Systemic absorption of topical corticosteroides can produce reversible hypothalmic-pituitary-adrenal (HPA) axis suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug or to reduce the frequency of application. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their large skin surface to body mass ratios.
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
Pregnancy & Lactation:
There is inadequate 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 cream should only be used in pregnancy if the benefit justifies the potential risk to the fetus and such use should not be extensive,i.e. in large amounts or for long periods. 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.
Precautions & Warnings:
In pregnancy, there is insufficient proof of safety. Clotrimazole is not teratogenic in animals, although it is foetotoxic at high dosages. Corticosteroids used topically to pregnant animals can cause fetal development problems. As a result, the cream should only be used during pregnancy if the benefit outweighs the danger to the fetus, and it should not be used in large amounts or for lengthy periods of time. Because it is unknown whether the preparation’s components are excreted in human milk, caution should be used when treating nursing women.
Betamethasone & Combined preparations
Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
Manufactured by: Opsonin Pharma Ltd.