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HALOBETASOL PROPIONATE CREAM, 0.05%

Rx Only

FOR DERMATOLOGICAL USE ONLY.

NOT FOR OPHTHALMIC USE.

DESCRIPTION

Halobetasol propionate cream 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-dione17-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 cream contains 0.5 mg/g of halobetasol propionate in a cream base of cetyl alcohol, diazolidinyl urea, glycerin, isopropyl isostearate, isopropyl palmitate, methylchloroisothiazolinone, (and) methylisothiazolinone, steareth-21 and water.

CLINICAL PHARMACOLOGY

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 .

INDICATIONS AND USAGE

Halobetasol propionate cream 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 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.

CONTRAINDICATIONS

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

PRECAUTIONS

ADVERSE REACTIONS

In controlled clinical trials, the most frequent adverse events reported for halobetasol propionate cream included stinging, burning or itching in 4.4% of the patients. Less frequently reported adverse reactions were: dry skin, erythema, skin atrophy, leukoderma, vesicles 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 cream. 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.

OVERDOSAGE:

Topically applied halobetasol propionate cream can be absorbed in sufficient amounts to produce systemic effects

(see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin layer of halobetasol propionate cream to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely. Halobetasol propionate cream 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 cream should not be used with occlusive dressings.

HOW SUPPLIED:

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

 15 g NDC 0168-0355-15
 50 g NDC 0168-0355-50

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

I2355
R9/04
#49

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