Land: Canada
Språk: engelsk
Kilde: Health Canada
TRETINOIN
SANOFI-AVENTIS CANADA INC
D10AD01
TRETINOIN
0.025%
CREAM
TRETINOIN 0.025%
TOPICAL
25GM
Prescription
CELL STIMULANTS AND PROLIFERANTS
Active ingredient group (AIG) number: 0112395002; AHFS:
CANCELLED POST MARKET
2008-08-04
PRODUCT MONOGRAPH VITAMIN A ACID ® 0.01% or 0.025% or 0.05% Gel 0.01% or 0.025% or 0.05% or 0.1% Cream TOPICAL ACNE THERAPY sanofi-aventis Canada Inc. Date of Preparation: 2150 St. Elzear Blvd. West May 8, 2006 Laval, Quebec H7L 4A8 Submission Control No. 106119 s-a Version 1.0 dated 2 NAME OF DRUG VITAMIN A ACID ® 0.01% or 0.025% or 0.05% Gel 0.01% or 0.025% or 0.05% or 0.1% Cream THERAPEUTIC CLASSIFICATION Topical Acne Therapy ACTIONS, CLINICAL PHARMACOLOGY The interest in oral Vitamin A in the treatment of acne started some 30 years ago following publication of a report by Straumfjord 1 and theoretical support for the use of the vitamin in the reduction of hyperkeratosis came from basic science investigations. Hunter and Pinkus 2 showed a reduction in the number of keratinocytes in the human _stratum corneum_ during oral Vitamin A therapy. Fell and Mellanby 3 noticed a suppression of keratinization by excessive Vitamin A in tissue culture. This led to the opinion that Vitamin A is antikeratinizing. Topical use of Vitamin A was suggested as a means of reducing systemic toxicity from Vitamin A taken orally and a number of topical forms of Vitamin A were tried. Vitamin A acid was found to be the most potent because of its greater peeling action. Vitamin A Acid has a very pronounced keratolytic action according to both Von Beer 4 and Von Stuttgen 5 . This action has led to its use in a number of dermatological conditions. It was tried successfully by Kligman et al 6 in the treatment of acne vulgaris since follicular hyperkeratosis is considered as being an initial stage of acne. INDICATIONS and CLINICAL USES Vitamin A Acid Gel is indicated for topical application in the treatment of acne vulgaris, primarily Grades I, II and III in which comedones, papules and pustules predominate. CONTRAINDICATIONS Use of the gel should be discontinued if hypersensitivity to any of the ingredients is noted. 3 WARNINGS Use in Pregnancy: Topical Vitamin A Acid should be used by women of childbearing years only after contraceptive Les hele dokumentet