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Cutivate (Fluticasone Propionate Topical) - Indications and Dosage

 
 



INDICATIONS AND USAGE

CUTIVATE® Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE® Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE® Cream in pediatric patients below 3 months of age have not been established.

DOSAGE AND ADMINISTRATION

CUTIVATE® Cream may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of CUTIVATE® Cream in pediatric patients for more than 4 weeks of use have not been established (see PRECAUTIONS: Pediatric Use). The safety and efficacy of CUTIVATE® Cream in pediatric patients below 3 months of age have not been established.

Atopic Dermatitis: Apply a thin film of CUTIVATE® Cream to the affected skin areas once or twice daily. Rub in gently.

Other Corticosteroid-Responsive Dermatoses: Apply a thin film of CUTIVATE® Cream to the affected skin areas twice daily. Rub in gently.

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.

CUTIVATE® Cream should not be used with occlusive dressings. CUTIVATE® Cream should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with CUTIVATE® Cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

CUTIVATE® (fluticasone propionate cream) Cream 0.05% is supplied in:

  •   30-g tubes (NDC 10337-332-30), and
  •   60-g tubes (NDC 10337-332-60).

Store between 2° and 30°C (36° and 86° F).

PharmaDerm®
A division of Fougera Pharmaceuticals Inc.
Melville, NY 11747 US
www.pharmaderm.com

I8332E

Rev. 06/12

#142

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