Land: Südafrika
Sprache: Englisch
Quelle: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
REDICOR 10 (film-coated tablets) REDICOR 20 (film-coated tablets) REDICOR 40 (film-coated tablets) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): REDICOR 10 (film-coated tablets) REDICOR 20 (film-coated tablets) REDICOR 40 (film-coated tablets) COMPOSITION: REDICOR 10: Each film-coated tablet contains simvastatin 10 mg REDICOR 20: Each film-coated tablet contains simvastatin 20 mg REDICOR 40: Each film-coated tablet contains simvastatin 40 mg PHARMACOLOGICAL CLASSIFICATION A 7.5 Serum-cholesterol reducers PHARMACOLOGICAL ACTION Simvastatin is a cholesterol-lowering agent derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion simvastatin, an inactive lactone, is hydrolysed to the corresponding beta-hydroxyacid, the active form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol. As a result simvastatin reduces total plasma cholesterol, low-density lipoprotein (LDL)- and very low- density lipoprotein (VLDL)-cholesterol concentrations. Apolipoprotein B is also decreased. In addition, simvastatin moderately increases high-density lipoprotein (HDL)-cholesterol and variably reduces plasma triglycerides. Pharmacokinetics There is extensive first-pass extraction by the liver, with oral bioavailability of the active medicine or metabolites being less than 5 %. More than 95 % of simvastatin and its beta-hydroxy metabolite are bound to plasma proteins. Following an oral dose peak plasma concentrations of simvastatin are seen in 1 to 2 hours. Simvastatin is excreted primarily via the liver and less than 13 % of its metabolites are excreted in the urine. INDICATIONS Hyperchole Lesen Sie das vollständige Dokument