Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
HYDROCORTISONE VALERATE (UNII: 68717P8FUZ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Glenamrk Pharmaceuticals Inc., USA
TOPICAL
PRESCRIPTION DRUG
Hydrocortisone valerate cream, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients. Hydrocortisone valerate cream, 0.2% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Hydrocortisone Valerate Cream USP, 0.2%, is supplied in the following tube sizes: 15 g – NDC 68462-575-17 45 g – NDC 68462-575-47 60 g – NDC 68462-575-65
Abbreviated New Drug Application
HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE CREAM GLENAMRK PHARMACEUTICALS INC., USA ---------- HYDROCORTISONE VALERATE CREAM USP, 0.2% RX ONLY FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION Hydrocortisone Valerate Cream USP, 0.2% contains hydrocortisone valerate, USP, pregn-4-ene-3,20- dione, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-, (11β)-;cortisol 17-valerate or 11β,17,21- Trihydroxypregn-4-ene-3,20-dione 17-valerate, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti- inflammatory and antipruritic agents. Chemically, hydrocortisone valerate, USP is C H O . It has the following structural formula: Hydrocortisone valerate, USP has a molecular weight of 446.58. It is a white or almost white crystalline powder, freely soluble in acetone and dichloromethane; soluble in alcohol; insoluble in water. Each gram of Hydrocortisone Valerate Cream USP, 0.2% contains 2 mg hydrocortisone valerate, USP in a hydrophilic base composed of citric acid monohydrate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sepineo P 600, steareth-100, stearyl alcohol, sodium lauryl sulfate and white petrolatum. CLINICAL PHARMACOLOGY Like other topical corticosteroids, hydrocortisone valerate 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 26 38 6 2 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 Կարդացեք ամբողջական փաստաթուղթը