Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
Physicians Total Care, Inc.
CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations 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/week because of the potential for the drug to suppress the hypothalamicpituitary- 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 Cream and Ointment, USP, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Clobetasol Propionate Cream, USP, 0.05% is supplied in Store cream between 15° and 30°C (59° and 86°F). Store ointment at controlled room temperature 20°-25°C (68°-77°F). Clobetasol propionate cream and ointment should not be refrigerated. Rx only Distributed by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 267/268:00 10/09 129159-1009 Relabeling of "Additional Barcode" label by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE CREAM PHYSICIANS TOTAL CARE, INC. ---------- CLOBETASOL PROPIONATE CREAM, USP, 0.05% CLOBETASOL PROPIONATE OINTMENT, USP, 0.05% RX ONLY FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. DESCRIPTION Clobetasol Propionate Cream and Ointment USP, 0.05% contain 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. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9- fluoro-11-hydroxy-16-methyl-17-(1- oxopropoxy)-pregna-1,4- diene-3,20-dione, and it has the following structural formula: Clobetasol propionate has the molecular formula C H CIFO and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum. 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 Citiți documentul complet