Quốc gia: Nam Phi
Ngôn ngữ: Tiếng Anh
Nguồn: South African Health Products Regulatory Authority (SAHPRA)
Schering
SKINOREN ACNE CREAM SCHEDULING STATUS: S1 PROPRIETARY NAME (and dosage form): SKINOREN ACNE CREAM Anti-acne agent COMPOSITION 1 g cream contains micronised azelaic acid (1,7-heptanedicarboxylic acid) 0,2 g (20%). The cream contains benzoic acid 0,2% w/w as a preservative. PHARMACOLOGICAL CLASSIFICATION A. 13.12 Acne preparations. PHARMACOLOGICAL ACTION The antimicrobial property of azelaic acid and a direct influence on follicular hyperkeratosis are assumed to be the basis for the therapeutic efficacy of Skinoren Acne Cream in acne. Azelaic acid exerts an antibacterial effect on Propionibacterium acnes and causes a significant reduction of the colonisation density of Propionibacterium acnes. A significant reduction of the fraction of free fatty acids in the skin surface lipids also occurs. In animal experiments azelaic acid inhibits the proliferation of cultivated keratinocytes (suppression of DNA synthesis) and accelerates the comedolysis of tetradecane-induced comedones. After treatment with Skinoren Acne Cream ultrastructural changes in particular of the keratohyaline granules and of filaggrin, an important factor in keratinisation occurred. These findings suggest that, under clinical conditions, Skinoren Acne Cream affects the keratinocytes and the pattern of keratinisation. The amount of azelaic acid recovered in the viable epidermis and the corium increased with the time of exposure and was approximately 9,5% of the applied dose after 24 hours. Following topical application of 1 g azelaic acid (5 g Skinoren Acne Cream) to human volunteers 2,2% (+ 0,7%) of the dose was excreted as unchanged substance in the urine within 72 hours. INDICATIONS Topical treatment of mild to moderate acne vulgaris. CONTRA-INDICATIONS Hypersensitivity to Skinoren Acne Cream (propylene glycol). Safety in p Đọc toàn bộ tài liệu