Betno CL®

Betamethasone & Clotrimazole

Prescribing Details



Description

Betno® CL cream is a preparation of Betamethasone Dipropionate and Clotrimazole. Betamethasone is a corticosteroid with anti-inflammatory, antipruritic and vasoconstrictive properties. But the exact mechanism of action of corticosteroids is not clearly known. 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.


Uses

No Data


Indications

Betno® CL cream is indicated for the topical treatment of inflammatory dermal infections like tinea pedis, tinea cruris and tinea corporis.


Dosage and administration

Route of administration: Betno® CL cream should be applied topically.
Sufficient cream 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 cream for longer than four weeks is not recommended.


Use in pregnancy & lactation

Pregnancy: There is inadequate evidence of safety in pregnancy. 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 (e.g., in large amounts or for long periods).

Lactation: 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.

Use in children and adolescents
Safety and effectiveness of the preparation has not been established in children below the age of 12 years.


Geriatric use
No Data

Precautions

If irritation or sensitization develops with the use of the cream, treatment should be discontinued and appropriate therapy instituted. 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 ratio.


Side effects

Most common side effects are paresthesia, rash, edema, secondary infection, burning, dry skin and stinging.


Contraindications

This cream is contraindicated in patients with a known history of hypersensitivity to corticosteroid, imidazole or any other components of this product. It is also contraindicated in facial rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, napkin eruptions and bacterial or viral infections.


Drug interactions

No information is available.


Overdose

Acute overdose with the cream is unlikely and would not be expected to lead to a life-threatening situation. The cream should not be used for longer than the prescribed time period.


Preparation

No Data


Pharmaceutical precautions

Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.


Presentation

Betno® CL cream: Each gram cream contains Betamethasone 0.5 mg as Betamethasone Dipropionate USP and Clotrimazole BP 10 mg.


Package quantities

Betno® CL cream: Tube of 15 g.