Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
HYDROCORTISONE VALERATE (UNII: 68717P8FUZ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Physicians Total Care, Inc.
HYDROCORTISONE VALERATE
HYDROCORTISONE VALERATE 2 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients. Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Hydrocortisone valerate cream USP, 0.2%, is supplied in: Hydrocortisone valerate ointment USP, 0.2% is supplied in: Store below 26°C (78°F). Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Issued: May, 2006 PK-5440-0 122 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
HYDROCORTISONE VALERATE - HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE - HYDROCORTISONE VALERATE OINTMENT PHYSICIANS TOTAL CARE, INC. ---------- RX ONLY FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2%, contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, 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 is C H O . It has the following structural formula: Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer 940, dibasic sodium phosphate, methylparaben, propylene glycol, purified water, sodium lauryl sulfate, steareth-2, steareth-100, stearyl alcohol and white petrolatum. Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer 934P, dibasic sodium phosphate, methylparaben, mineral oil, propylene glycol, purified water, sodium lauryl sulfate, steareth-2, steareth-100, stearyl alcohol 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 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 t read_full_document