Nchi: Afrika Kusini
Lugha: Kiingereza
Chanzo: South African Health Products Regulatory Authority (SAHPRA)
Janssen
RENOVA cream SCHEDULING STATUS: Schedule 3 PROPRIETARY NAME (and dosage form): RENOVA cream COMPOSITION Each gram of cream contains 0,5 mg tretinoin in a water-in-oil emulsion. Preservatives: Methyl parahydroxybenzoate 0,2% (w/w) Quaternium-15 0,1% (w/w) Antioxidant: Butylhydroxytoluene 0,1% (w/w). PHARMACOLOGICAL CLASSIFICATION A.13.5 Emollients and protectives. PHARMACOLOGICAL ACTION Pharmacodynamics The mechanism of action of topical tretinoin as a treatment for photodamage is not completely understood. It is, however known that tretinoin activates gene transcription for many important proteins by binding to specific retinoid receptors in the cell nucleus. Ultrastructural studies show an increased number of anchoring fibrils in the papillary dermis of tretinoin- treated photodamaged skin. These molecular events, coupled with the characteristic histologic effects of tretinoin i.e. increased epidermal and granular layer thickness with changes in stratum corneum morphology, indicate a specific effect rather than one induced by irritation, as has been previously suggested. Pharmacokinetics Upon topical application of RENOVA, tretinoin penetrates both the epidermis and dermis. The mean percutaneous absorption following single and repeated applications is less than 2% and physiologic concentrations of tretinoin and its major metabolites are unaltered. INDICATIONS RENOVA is indicated as adjunctive therapy for the topical treatment of mottled hyperpigmentation, roughness and fine wrinkling of photodamaged skin due to chronic sun exposure in patients who do not achieve improvement with comprehensive skin care programs and sun avoidance measures. There is no convincing evidence that RENOVA cream eliminates wrinkles, repairs sun damaged skin, reverses photoageing, or restores a more youthful or younger Soma hati kamili