Clobetasol (Clobetasol Propionate Topical) - Indications and Dosage

INDICATIONS AND USAGE

Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

DOSAGE AND ADMINISTRATION

Apply a thin layer of clobetasol propionate cream or ointment to the affected skin areas twice daily and rub in gently and completely.

Clobetasol propionate cream and ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Clobetasol propionate cream and ointment should not be used with occlusive dressings.

HOW SUPPLIED

Clobetasol Propionate Cream USP, 0.05% is supplied in tamper-evident tubes as follows:

                15 g (NDC 0168-0163-15)                30 g (NDC 0168-0163-30)
                45 g (NDC 0168-0163-46)                60 g (NDC 0168-0163-60)

Clobetasol Propionate Ointment USP, 0.05% is supplied in tamper-evident tubes as follows:

                15 g (NDC 0168-0162-15)                30 g (NDC 0168-0162-30)
                45 g (NDC 0168-0162-46)                60 g (NDC 0168-0162-60)

Store at controlled room temperature 15°-30°C (59°-86°F). DO NOT REFRIGERATE

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747
www.fougera.com

I2162D
R8/03
#202