ALCLOMETASONE DIPROPIONATE

Alclometasone Dipropionate Cream USP, 0.05% contains alclometasone dipropionate (7α-chloro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate is C28H37ClO7. It has the following structural formula: Alclometasone dipropionate has the molecular weight of 521. It is a white powder, insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol. Each gram of alclometasone dipropionate cream contains 0.5 mg of alclometasone dipropionate in a hydrophilic, emollient cream base of Ceteth-20, cetyl alcohol, chlorocresol, glyceryl monostearate, monobasic sodium phosphate, PEG 100 stearate, phosphoric acid, propylene glycol, purified water, stearyl alcohol, and white petrolatum. Chemical Structure

Alclometasone Dipropionate Cream USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use ). Since the safety and efficacy of alclometasone dipropionate cream have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

Apply a thin film of Alclometasone Dipropionate Cream USP, 0.05% to the affected skin areas two or three times daily; massage gently until the medication disappears. Alclometasone dipropionate cream may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate cream in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Alclometasone dipropionate cream should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate cream should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

Alclometasone Dipropionate Cream USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in this preparation.

The following local adverse reactions have been reported with alclometasone dipropionate cream in approximately 2% of patients: itching and burning, erythema, dryness, irritation, and papular rashes. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].