A fixed-dose topical combination of a moderately potent corticosteroid (Clobetasone butyrate) and a broad-spectrum imidazole antifungal (Miconazole nitrate). It is primarily indicated for the treatment of inflammatory dermatoses complicated by or at high risk of fungal infections, particularly in the moist, intertriginous areas common in the Indian tropical climate. It provides anti-inflammatory, antipruritic, vasoconstrictive, and antifungal actions.
Adult: Apply a thin film to the affected area twice daily (morning and evening). Duration should be limited to a maximum of 2 weeks for body and 1 week for face/flexures unless directed by a physician.
Note: Wash and dry the affected area thoroughly. Apply a thin layer and rub gently until absorbed. Wash hands after application unless hands are being treated. Do not bandage or cover the area tightly (occlusion) unless specifically advised. Do not use near eyes, mouth, or inside nose/vagina.
Clobetasone acts by inducing phospholipase A2 inhibitory proteins (lipocortins), which inhibit the release of inflammatory mediators like prostaglandins and leukotrienes. It causes vasoconstriction and reduces capillary permeability. Miconazole inhibits the synthesis of ergosterol, a critical component of fungal cell membranes, by blocking the cytochrome P450-dependent enzyme lanosterol 14-α-demethylase. This leads to increased membrane permeability and cell death.
Pregnancy: Category C (US FDA). Topical corticosteroids, especially potent ones, can be absorbed in amounts sufficient to cause systemic effects. Animal studies show teratogenicity. Use only if potential benefit justifies potential risk to fetus. Avoid large amounts, long duration, and occlusion. Miconazole topical is generally considered low risk.
Driving: No known effects. However, if applied to hands, ensure cream is fully absorbed to prevent slippery grip.
| Warfarin and other Coumarin Anticoagulants | Miconazole (systemic) can potentiate anticoagulant effect, increasing INR and bleeding risk. Risk with topical use is low but possible with large surface area application. | Moderate |
| Oral Hypoglycemic Agents (Sulfonylureas) | Miconazole may potentiate hypoglycemic effect. Monitor blood glucose. | Moderate |
| Phenytoin, Carbamazepine | Miconazole may increase serum levels of these drugs. Risk is primarily with systemic miconazole. | Low |
| Other Topical Corticosteroids | Concomitant use increases risk of local and systemic steroid adverse effects. | High |
| Topical Tacrolimus, Pimecrolimus | May increase risk of skin infection. Use with caution and not concurrently on same site. | Moderate |
Same composition (Clobetasone (0.05% w/w) + Miconazole (2% w/w)), different brands: