Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
Cosette Pharmaceuticals, Inc.
Clobetasol Propionate
Clobetasol Propionate 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Clobetasol Propionate Ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients 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. Clobetasol Propionate Ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Safety and effectiveness of Clobetasol Propionate Ointment in pediatric patients have not been established. Use in children under 12 years of age is not recommended. Because of a higher rati
Clobetasol Propionate Ointment, USP 0.05% is supplied in: 15 g tubes (NDC 0713-0656-15) 30 g tubes (NDC 0713-0656-31) 45 g tubes (NDC 0713-0656-37) 60 g tubes (NDC 0713-0656-60) Store at 20°- 25°C (68°-77°F) [See USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 06/2022 8-0656CPLNC2 VC7642
Abbreviated New Drug Application
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT COSETTE PHARMACEUTICALS, INC. ---------- CLOBETASOL PROPIONATE OINTMENT, USP 0.05% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE RX ONLY DESCRIPTION Clobetasol Propionate Ointment, USP 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β- methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C H ClFO and a molecular weight of 466.98. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. 25 32 5 CLINICAL PHARMACOLOGY Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, 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 dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances p Belgenin tamamını okuyun