Country: United States
Language: English
Source: NLM (National Library of Medicine)
HALOBETASOL PROPIONATE (UNII: 91A0K1TY3Z) (HALOBETASOL - UNII:9P6159HM7T)
Physicians Total Care, Inc.
HALOBETASOL PROPIONATE
HALOBETASOL PROPIONATE 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Halobetasol propionate cream, 0.05% is a super-high potency corticosteroid indictated 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 cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Halobetasol propionate cream, 0.05% is supplied in the following tube sizes: 50 g (NDC 54868-4907-0 ) Store at 20 - 25°C (68 - 77°F) (See USP Controlled Room Temperature). MADE IN ISRAEL MANUFACTURED BY PERRIGO, YERUHAM, ISRAEL 80500 DISTRIBUTED BY PERRIGO® ALLEGAN, MI 49010 Rev. 5/07 4C600 RC J2
Abbreviated New Drug Application
HALOBETASOL PROPIONATE - HALOBETASOL PROPIONATE CREAM PHYSICIANS TOTAL CARE, INC. ---------- 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, C H ClF O . 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 A , 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 A . 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. Read the complete document