Kraj: Kanada
Język: angielski
Źródło: Health Canada
HYDROCORTISONE VALERATE
TAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC.
D07AA02
HYDROCORTISONE
0.2%
OINTMENT
HYDROCORTISONE VALERATE 0.2%
TOPICAL
60G
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0112513001; AHFS:
APPROVED
2003-09-03
PRODUCT MONOGRAPH HydroVal (Hydrocortisone Valerate) Cream & Ointment 0.2 % Topical Corticosteroid TaroPharma Preparation Date: A Division of Taro Pharmaceuticals Inc. Sept 02, 2003 130 East Drive Brampton, Ontario Revision Date: L6T 1C1 August 6, 2003 Control #086230 1 PRODUCT MONOGRAPH HydroVal Cream & Ointment 0.2 % (Hydrocortisone Valerate Cream, USP) (Hydrocortisone Valerate Ointment, USP) Topical Corticosteroid ACTIONS AND CLINICAL PHARMACOLOGY HydroVal 0.2% (hydrocortisone valerate) cream and ointment are moderately potent non-fluorinated, topical corticosteroids. Topical corticosteroids are synthetic derivatives of cortisone which are effective when applied locally to control many types of inflammatory, allergic and pruritic dermatoses. Modifications to the chemical structure such as fluorination, generally enhances both anti-inflammatory activity and increases the likelihood of adverse effects. The mechanism of anti-inflammatory activity of topical corticosteroids is generally unclear. However, corticosteroids are thought to induce phospholipase A2 inhibitor proteins, preventing arachidonic acid release and the biosynthesis of potent mediators of inflammation. Topical corticosteroids are primarily effective because of their anti- inflammatory, anti-pruritic and vasoconstrictive actions. 2 Topical absorption of corticosteroids follow the same pharmacologic fate as systemically administered doses: corticosteroids in the circulation are bound to plasma proteins, although the fluorinated compounds are bound to a lesser degree, accounting for their increased potency compared to natural corticosteroids. It is generally known that steroid hormones are metabolized predominantly in the liver and to a lesser extent in the kidney, intestines, spleen, muscles and other tissues and then excreted in the urine as conjugates. INDICATIONS AND CLINICAL USE HydroVal 0.2% (hydrocortisone valerate) cream and ointment are indicated for topical therapy of acute and chronic corticosteroid responsive dermatoses, where an anti-in Przeczytaj cały dokument