Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Bayer
BAYCOL 0,1 Tablet BAYCOL 0,2 Tablet BAYCOL 0,3 Tablet SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): BAYCOL 0,1 Tablet BAYCOL 0,2 Tablet BAYCOL 0,3 Tablet COMPOSITION: BAYCOL 0,1: Each tablet contains 0,1 mg cerivastatin sodium BAYCOL 0,2: Each tablet contains 0,2 mg cerivastatin sodium BAYCOL 0,3: Each tablet contains 0,3 mg cerivastatin sodium PHARMACOLOGICAL CLASSIFICATION: A 7.5 Serum-cholesterol reducers. PHARMACOLOGICAL ACTION: Cerivastatin sodium is a synthetic, pure enantiomeric competitive cholesterol synthesis inhibitor which inhibits the enzyme HMG-CoA reductase (hydroxy-methyl-glutaryl coenzyme A) This enzyme catalyses the rate-determining step in the synthesis of cholesterol, the conversion of HMG-CoA to mevalonic acid. The primary site of action of cerivastatin sodium is the liver. By reducing intracellular cholesterol content, cerivastatin sodium causes secondary up-regulation of the hepatic LDL receptors with increased LDL cholesterol clearance and reduction of both total and LDL cholesterol in the serum. Cerivastatin sodium is readily absorbed from the gastrointestinal tract, reaching maximum plasma concentrations (Cmax) 2-3 hours after oral administration. The absolute bioavailability of cerivastatin sodium is about 60%. The pharmacokinetics of cerivastatin sodium are not influenced by concomitant administration of food. Cerivastatin sodium is highly bound to plasma proteins (99,1-99,5%). The drug penetrates only moderately into tissues. No accumulation is observed on repeated administration. With a clearance of about 13 L/hour, cerivastatin sodium can be regarded as a low clearance drug. Cerivastatin sodium is eliminated by cytochrome P450 mediated biotransformation with a plasma elimination half-life of approximately 2-3 hours. Th Les hele dokumentet