Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN SIMVASTATIN 10 MG (TABLET) ASPEN SIMVASTATIN 20 MG (TABLET) ASPEN SIMVASTATIN 40 MG (TABLET) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ASPEN SIMVASTATIN 10 MG (TABLET) ASPEN SIMVASTATIN 20 MG (TABLET) ASPEN SIMVASTATIN 40 MG (TABLET) COMPOSITION Each tablet contains: ASPEN SIMVASTATIN 10 MG: Simvastatin 10 mg (active ingredient), 2,50% m/m ascorbic acid (antioxidant), 0,02% m/m butylated hydroxyanisole (antioxidant) ASPEN SIMVASTATIN 20 MG: Simvastatin 20 mg (active ingredient), 5,0% m/m ascorbic acid (antioxidant), 0,04% m/m butylated hydroxyanisole (antioxidant) ASPEN SIMVASTATIN 40 MG: Simvastatin 40 mg (active ingredient), 10,00% m/m ascorbic acid (antioxidant), 0,08% m/m butylated hydroxyanisole (antioxidant) 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 Read the complete document