देश: दक्षिण अफ़्रीका
भाषा: अंग्रेज़ी
स्रोत: South African Health Products Regulatory Authority (SAHPRA)
Schering
SKINOREN GEL SCHEDULING STATUS: S1 PROPRIETARY NAME (and dosage form): SKINOREN GEL COMPOSITION 1 g Skinoren Gel contains 0,15 g (15% m/m) micronised azelaic acid and 0,001 g (0,1% m/m) benzoic acid as a preservative. PHARMACOLOGICAL CLASSIFICATION A. 13.12 Acne preparations. PHARMACOLOGICAL ACTION Pharmacodynamic properties The antimicrobial action of azelaic acid and a direct influence on follicular hyperkeratosis are assumed to be the basis for the therapeutic efficacy of Skinoren Gel in acne. Clinically, a significant reduction in the colonisation density of Propionibacterium acnes and a significant reduction in the fraction of free fatty acids in the skin surface lipids is observed. In vitro and in vivo, azelaic acid inhibits the proliferation of keratinocytes and normalises the disturbed terminal epidermal differentiation processes in acne. In the rabbit ear model azelaic acid accelerates the comedolysis of tetradecane-induced comedones. Pharmacokinetic properties Azelaic acid penetrates into all layers of the skin after topical application of the gel. Penetration is faster into damaged skin than into intact skin. A total of 3,6% of the dose applied is absorbed percutaneously after a single topical application of 1 g azelaic acid (5 g Skinoren Acne Cream). Clinical investigations in acne patients indicated similar absorption rates of azelaic acid from Skinoren Gel and cream. A portion of the azelaic acid absorbed through the skin is excreted in unchanged form with the urine. The remaining portion is broken down by beta-oxidation into dicarboxylic acids with shorter chain length (C 7 , C 5 ) which have likewise been found in the urine. INDICATIONS Mild to moderate acne vulgaris. CONTRA-INDICATIONS Hypersensitivity to any ingredient of the gel, in particular propylene glycol. पूरा दस्तावेज़ पढ़ें