HALOBETASOL PROPIONATE OINTMENT, 0.05%

Rx Only

FOR DERMATOLOGICAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Halobetasol propionate ointment contains halobetasol propionate, a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agent. Chemically halobetasol propionate is 21-chloro-6α,9-difluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione,17-propionate, C₂₅H₃₁CIF₂O₅ . It has the following structural formula:

Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water. Each gram of Halobetasol propionate ointment contains 0.5 mg/g of halobetasol propionate in a base of aluminum stearate, beeswax, pentaerythritol cocoate, petrolatum, propylene glycol, sorbitan sesquioleate, and stearyl citrate.

Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A₂ .

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.

Halobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

In controlled clinical trials, the most frequent adverse events reported for halobetasol propionate ointment included stinging or burning in 1.6% of the patients. Less frequently reported adverse reactions were: pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection, telangiectasia, urticara, dry skin, miliaria, paresthesia, and rash. The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as halobetasol propionate ointment. These reactions are uled in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

Topically applied halobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

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.

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