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Halobetasol (Halobetasol Propionate Topical) - Description and Clinical Pharmacology

 
 



For Dermatologic Use Only.     Not for Ophthalmic Use.

Rx Only

DESCRIPTION

Halobetasol propionate cream, 0.05% 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 cream, 0.05% contains 0.5 mg 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.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Human and animal studies indicate that less than 6% of the applied dose of halobetasol propionate enters the circulation within 96 hours following topical administration of the cream.

Studies performed with halobetasol propionate cream, 0.05% indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

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