Betamethasone + Clotrimazole Topical

Betamethasone 0.05% + Clotrimazole 1% Topical is a combination of two medicines: Betamethasone and Clotrimazole. Betamethasone is a steroid which blocks the production of certain chemical messengers (prostaglandins) that make the skin red, swollen and itchy. Clotrimazole is an antifungal which stops the growth of fungi on the skin by preventing them from forming their own protective covering.

This cream is applied to the affected area twice daily. It is used for 2 weeks for tinea corporis and tinea cruris, and 4 weeks for tinea pedis.

• Inflammatory dermal infections
• Tinea pedis
• Tinea cruris
• Tinea corporis

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.

Betamethasone prevents and reduces inflammation by depressing the migration of polymorphonuclear leukocytes and fibroblasts; reversing capillary permeability and lysosomal stabilisation at the cellular level. Clotrimazole binds to phospholipids in the fungal cell membrane, altering cell wall permeability and causing loss of essential intracellular components.

Adults: Apply a thin layer to the affected area twice daily.

• Tinea corporis and tinea cruris: Up to 2 weeks
• Tinea pedis: Up to 4 weeks
• Maximum weekly dose: 45 g

Children (under 17 years): Safety and efficacy have not been established.

For external use only. Use in the dose and duration as advised by your doctor. Check the label for directions before use. Clean and dry the affected area and apply the cream. Wash your hands after applying. Avoid contact with eyes, mouth, or vagina.

If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double the dose.

• Application site burning, itching, redness
• Thinning of skin
• Skin peeling
• Paresthesia (1.9%)
• Dry skin (1.6%)
• Stinging (<1%)
• Rash, edema, secondary infection (<1%)

• For use on skin only; avoid eyes, mouth, and vagina
• Do not use occlusive dressings unless directed by a doctor
• If severe irritation or allergy occurs, discontinue use
• Do not use for longer than 4 weeks without medical advice
• Inform your doctor if no improvement after 2 weeks
• Caution during pregnancy and lactation

• Hypersensitivity to betamethasone, clotrimazole, or any component
• Facial rosacea
• Acne vulgaris
• Perioral dermatitis
• Perianal and genital pruritus
• Napkin eruptions
• Bacterial or viral infections

No significant drug interactions are known.

No food-related restrictions (topical application).

[CONSULT YOUR DOCTOR] There is inadequate evidence of safety in pregnancy. Clotrimazole has no teratogenic effect in animals but is foetotoxic at high oral doses. Topical corticosteroids can cause fetal abnormalities in animals. Use only if the benefit justifies the potential risk and not for large areas or long periods.

[SAFE IF PRESCRIBED] It is not known whether the components are excreted in human milk. Caution is advised in nursing mothers.

Safety and efficacy in children under 17 years have not been established. Also not established in children under 12 years.

No dose adjustment needed for elderly patients, but caution is advised.

Systemic absorption with topical application is minimal, but prolonged use on large areas may cause HPA axis suppression. Caution in renal or hepatic impairment.

Acute overdose is unlikely and not life-threatening. Do not use for longer than prescribed.

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

Betamethasone Dipropionate (0.05%) + Clotrimazole (1%)