Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
Aleor Dermaceuticals Limited
TOPICAL
PRESCRIPTION DRUG
Clobetasol propionate cream, USP 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/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 cream USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Clobetasol Propionate Cream USP, 0.05% is available as a white to off-white cream. It is supplied as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Clobetasol Propionate Cream USP, 0.05% should not be refrigerated. Manufactured for: Aleor Dermaceuticals Ltd., Karakhadi, Vadodara 391450, India. Manufactured by: Aleor Dermaceuticals Ltd., Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Revised: 11/2021
Abbreviated New Drug Application
CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE CREAM ALEOR DERMACEUTICALS LIMITED ---------- CLOBETASOL PROPIONATE CREAM USP, 0.05% RX ONLY FOR TOPICAL DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. DESCRIPTION Clobetasol Propionate Cream USP, 0.05% contain the active compound clobetasol propionate, USP 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, USP is Pregna-1,4-diene-3,20-dione, 21-chloro-9- fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11β,16β), and it has the following structural formula: Clobetasol propionate, USP has the molecular formula C H ClFO and a molecular weight of 466.97. It is a white to almost white crystalline powder insoluble in water. Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate, USP 0.5 mg/g in a cream base composed of anhydrous citric acid, cetyl alcohol, 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. 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 25 32 5 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 Lire le document complet