Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
Halobetasol Propionate (UNII: 91A0K1TY3Z) (Halobetasol - UNII:9P6159HM7T)
Taro Pharmaceuticals U.S.A., Inc.
Halobetasol Propionate
Halobetasol Propionate 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Halobetasol Propionate Ointment, 0.05% 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. Halobetasol Propionate Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Halobetasol Propionate Ointment, 0.05% is supplied in 5 g physician samples (tubes only - NDC 51672-1322-5), 15 g (NDC 51672-1322-1) and 50 g (NDC 51672-1322-3) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Abbreviated New Drug Application
HALOBETASOL PROPIONATE- HALOBETASOL PROPIONATE OINTMENT TARO PHARMACEUTICALS U.S.A., INC. ---------- HALOBETASOL PROPIONATE OINTMENT, 0.05% RX ONLY FOR DERMATOLOGICAL USE ONLY NOT FOR OPHTHALMIC USE. DESCRIPTION Halobetasol Propionate Ointment, 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 antiinflammatory 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 Ointment contains 0.5 mg/g of halobetasol propionate in a base of aluminium stearate, pentaerythritol cocoate, propylene glycol, sorbitan sesquioleate, stearyl citrate, white petrolatum and white wax. 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 penet Aqra d-dokument sħiħ