Aristoderm (Betamethasone + Clotrimazole + Gentamicin)

Each gram Aristoderm Cream contains Betamethasone Dipropionate USP 0.64 mg eq. to Betamethasone 0.5 mg, Clotrimazole USP 10 mg and Gentamicin Sulfate USP 1.693 mg eq. to Gentamicin 1 mg.

Presentation

Aristoderm Cream combines the anti-inflammatory, antipruritic and vasoconstrictive actions of Betamethasone with the broad spectrum antifungal activity of Clotrimazole and the wide-spectrum bactericidal antibiotic activity of Gentamicin. Clotrimazole appears to act on the fungal cell membrane, causing leakage of cell contents. Gentamicin provides highly effective topical treatment in primary and secondary bacterial infections of the skin.

Indications

Aristoderm Cream is indicated for the treatment of corticosteroid-responsive dermatoses when complicated by infections caused by bacteria and fungi. Aristoderm Cream is also effective in the treatment of tinea pedis, tinea cruris, tinea corporis & acute and chronic eczema.

Dosage & Administration

Apply gently into the affected skin areas twice daily. Duration of therapy varies depending upon the extent and location of disease and patient response. For effective treatment, Aristoderm Cream should be applied regularly.

Contrainidications

Contraindicated in those patients with a history of sensitivity reactions to any of the cream components.

Warning & Precautions

– Do not combine with any other product containing corticosteroid.
– Not for application to the face, avoid contact with eyes.
– Not for prolonged use or use in extensive areas, under an occlusive dressing, open wound, injured areas and skin folds.
Overdose:
Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency and produce manifestations of hypercorticism, including Cushing’s disease.

Side effects

Adverse reactions to this preparation have been reported very rarely and include hypochromia, burning, erythema, exudation etc.

Drug interaction

Concomitant use with nephrotoxic drugs including other aminoglycosides, vancomycin and some of cephalosporins; or ototoxic drugs such as ethacrynic acid and furosemide may increase the risk of toxicity.

Use in special groups

Use in Pregnancy & Lactation:
Since safety of topical corticosteroid in pregnant women has not been established, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Caution should be exercised when treating nursing mothers.

Use in children:
The safety and effectiveness of this preparation has not been established in children