Indications of Betavate-CL Ointment

Moderate to severe inflammatory fungal infections like tinea pedis, tinea cruris, tinea corporis, etc.

Pharmacology of Betavate-CL Ointment

Clotrimazole is a broad-spectrum antifungal agent used to treat superficial infections caused by pathogenic dermatophytes, yeasts, and Malassezia furfur. The mechanism of action involves inhibiting the synthesis of ergosterol, which is an important sterol in fungal cell membranes. This leads to the instability of the cell membrane and ultimately to the death of the fungus. Betamethasone dipropionate is a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. However, the exact mechanism of action of corticosteroids is still unclear.

Dosage & Administration of Betavate-CL Ointment

Apply to the affected and surrounding skin areas twice a day, in the morning and evening for 2- 4 weeks.

Contraindications

This topical preparation is contraindicated in patients who are sensitive to any of its ingredients or other corticosteroids or imidazole. If the use of cream causes irritation or allergies, treatment should be stopped and appropriate treatment started. The cream is contraindicated in facial rosacea, acne vulgaris, perioral dermatitis, perianal and genital itching, diaper rash, and bacterial or viral infections. Systemic absorption of local corticosteroids can produce reversible inhibition of the hypothalamic-pituitary-adrenal (HPA) axis. If HPA axis inhibition is observed, try to withdraw the drug or reduce the frequency of use. Pediatric patients may be more susceptible to systemic toxicity at equivalent doses due to their large skin surface area to body weight ratio.

Side Effects of Betavate-CL Ointment

Adverse drug reactions reported in clinical trials were 1.9% of patients with paraesthesia, rash, edema, and secondary infection, and less than 1% of patients each. Other adverse reactions reported were dry and burning skin in 1.6% of patients and tingling sensation in less than 1% of patients.

Pregnancy & Lactation

There is insufficient evidence to prove safety during pregnancy. Clotrimazole has no teratogenic effect on animals, but it has fetal toxicity when taken orally in high doses. Topical use of corticosteroids in pregnant animals can cause abnormal fetal development. Therefore, if the benefits justify the potential risk to the fetus, the cream should only be used during pregnancy, and such use should not be widespread, ie. Large amounts or long-term. It is not clear whether the ingredients of this preparation will be excreted from human milk, so caution should be exercised when treating breastfeeding mothers.

Precautions & Warnings

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-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.

Therapeutic Class

Betamethasone & Combined preparations

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Pharmaceutical Name of Betavate-CL Ointment

Drug International Ltd

Generic of Betavate-CL Ointment

Betamethasone + Clotrimazole