This topical preparation is indicated for the treatment of inflammatory fungal skin infections, including:

• Tinea pedis (athlete’s foot)
• Tinea cruris (jock itch)
• Tinea corporis (ringworm)

Clotrimazole is a broad-spectrum antifungal agent effective against dermatophytes, yeasts, and Malassezia furfur. It works by inhibiting the synthesis of ergosterol, an essential component of the fungal cell membrane, leading to membrane disruption and fungal cell death. Betamethasone dipropionate is a potent corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Although its exact mechanism is not fully understood, it helps reduce inflammation, redness, and itching associated with skin infections.

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.

No clinically significant drug interactions have been reported with this topical preparation.

This preparation is contraindicated in patients with known hypersensitivity to any of its components, other corticosteroids, or imidazole antifungals. Treatment should be discontinued if irritation or sensitization occurs, and appropriate therapy should be initiated. It is also contraindicated in conditions such as facial rosacea, acne vulgaris, perioral dermatitis, perianal and genital itching, diaper rash, and untreated bacterial or viral infections. Systemic absorption of topical corticosteroids may lead to reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis. If such suppression occurs, the medication should be withdrawn or the frequency of application reduced. Pediatric patients may be more susceptible to systemic toxicity due to a higher skin surface area to body weight ratio.

In clinical studies, paresthesia was reported in about 1.9% of patients. Rash, edema, and secondary infections were reported in less than 1% of patients. Other side effects include burning sensation and dry skin (about 1.6%), and stinging sensation in less than 1% of patients.

Adequate safety data in pregnancy are not available. Although clotrimazole is not teratogenic in animals, high oral doses may cause fetal toxicity. Topical corticosteroids may also affect fetal development. Therefore, this preparation should be used during pregnancy only if the benefits outweigh the risks, and should not be applied over large areas or for prolonged periods. It is not known whether the components are excreted in human milk, so caution is advised when used in nursing mothers.

Acute overdose is unlikely and is not expected to cause life-threatening effects. However, the cream should not be used for longer than the prescribed duration.

Betamethasone & combined preparations.

Store below 30°C, protected from light and moisture. Keep out of reach of children.