Halobetasol (Halobetasol Propionate Topical) - Indications and Dosage

INDICATIONS AND USAGE

Halobetasol propionate ointment is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/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 corticosteroid, 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 halobetasol propionate ointment to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely. Halobetasol propionate ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary.

Halobetasol propionate ointment should not be used with occlusive dressings.

HOW SUPPLIED

Halobetasol Propionate Ointment, 0.05% is supplied in the following tube sizes:

•  15 g NDC 0168-0356-15
  50 g NDC 0168-0356-50

Store at 20°-25°C (68°-77°F), with excursions permitted between 15°-30°C (59°-86°F).

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

I2356
R9/04
#86