Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)
Cosette Pharmaceuticals, Inc.
Betamethasone Valerate
Betamethasone Valerate 1.2 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topic
Betamethasone Valerate Cream USP, 0.1% is supplied as follows: 15 g tubes NDC 0713-0326-15 45 g tubes NDC 0713-0326-37 Betamethasone Valerate Ointment USP, 0.1% is supplied as follows: 15 g tubes NDC 0713-0327-15 45 g tubes NDC 0713-0327-37 Store at room temperature 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 03/2022 8-BETVCPLNC3 VC7618
Abbreviated New Drug Application
BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE- BETAMETHASONE VALERATE OINTMENT COSETTE PHARMACEUTICALS, INC. ---------- BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% (POTENCY EXPRESSED AS BETAMETHASONE) RX ONLY FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION Betamethasone Valerate Cream and Ointment contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy- 16β-methylpregna-1,4-diene-3,20-dione 17-valerate. The structural formula is: Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, sodium phosphate monobasic (monohydrate), white petrolatum, polyethylene glycol 1000, ceteareth-15, stearyl alcohol, cetyl alcohol, propylene glycol, phosphoric acid (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum, mineral oil, and hydrogenated lanolin. CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in Прочитать полный документ