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Uses
ACLOVATE® Cream and Ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ACLOVATE® Cream and Ointment 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 ACLOVATE® Cream and Ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.
History
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Other Information
ACLOVATE® (alclometasone dipropionate cream) Cream, 0.05% and ACLOVATE® (alclometasone dipropionate ointment) Ointment, 0.05% contain 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 C28H37CIO7. 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 ACLOVATE® Cream contains 0.5 mg of alclometasone dipropionate in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, glyceryl stearate, PEG 100 stearate, Ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water.
Each gram of ACLOVATE® Ointment contains 0.5 mg of alclometasone dipropionate in an ointment base of hexylene glycol, white wax, propylene glycol stearate, and white petrolatum.
Sources
Aclovate Manufacturers
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Pharmaderm, A Division Of Nycomed Us Inc.
Aclovate | Pharmaderm, A Division Of Nycomed Us Inc.
Apply a thin film of ACLOVATE® Cream or Ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.
ACLOVATE® Cream and Ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of ACLOVATE® Cream or Ointment 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.
ACLOVATE® Cream or Ointment should not be used with occlusive dressings unless directed by a physician. ACLOVATE® Cream or Ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with ACLOVATE® Cream or Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
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