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Cerivastatin: profile and news
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Feb 11, 2005 Other information Indication For management as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels in patients with primary hypercholesterolemia and mixed dyslipidemia Pharmacology Cerivastatin, a competitive HMG-CoA reductase inhibitor effective in lowering LDL cholesterol and triglycerides, is used to treat primary hypercholesterolemia and mixed dyslipidemia (Fredrickson types IIa and IIb). Mechanism Of Action Cerivastatin competitively inhibits hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase, the hepatic enzyme responsible for converting HMG-CoA to mevalonate. As mevalonate is a precursor of sterols such as cholesterol, this results in a decrease in cholesterol in hepatic cells, upregulation of LDL-receptors, and an increase in hepatic uptake of LDL-cholesterol from the circulation. Drug Category Anticholesteremic Agents; Antilipemic Agents; ATC:C10AA06 Brand Names/Synonyms Baycol; Cerivastatin; Cerivastatin Sodium; Cerivastatin, Sodium Salt; None; Rivastatin, Baycol, Lipobay Dosage Forms tablets Absorption 60% (range 39 - 101% ) Interactions Interactions for Cerivastatin: Immunosuppressive Drugs, Fibric Acid Derivatives, Niacin (Nicotinic Acid, Erythromycin, Azole Antifungals: Skeletal Muscle. ANTACID (Magnesium-Aluminum Hydroxide): Cerivastatin plasma concentrations were not affected by co-administration of antacid. CIMETlDINE: Cerivastatin plasma concentrations were not affected by co-administration of cimetidine. CHOLESTYRAMINE: The influence of the bile-acidsequestering agent cholestyramine on the pharmacokinetits of cerivastatin sodium was evaluated in 12 healthy males in 2 separate randomized crossover studies. In the first study, concomitant administration of 0.2 mg cerivastatin sodium and 12 g cholestyramine resulted in decreases of more than 22% for AUC and 40% for Cmax when compared to dosing cerivastatin sodium alone. However, in the second study, administration of 12 g cholestyramine 1 hour before the evening meal and 0.3 mg cerivastatin sodium approximately 4 hours after the same evening meal resulted in a decrease in the cerivastatin AUC of less than 8%, and a decrease in Cmax of about 30% when compared to dosing cerivastatin sodium alone. Therefore, it would be expected that a dosing schedule of cerivastatin sodium given at bedtime and cholestyramine given before the evening meal would not result in a significant decrease in the clinical effect of cerivastatin sodium. DIGOXIN: Plasma digoxin levels and digoxin clearance at steady-state were not affected by co-administration of 0.2 mg cerivastatin sodium. Cerivastatin plasma concentrations were also not affected by co-administration of digoxin. WARFARIN: Co- administration of warfarin and cerivastatin to healthy volunteers did not result in any changes in prothrombin time or clotting factor VII when compared to co-administration of warfarin and placebo. The AUC and Cmax of both the (R) and (S) isomers of warfarin were unaffected by concurrent dosing of 0.3 mg cerivastatin sodium. Co-administration of warfarin and cerivastatin did not alter the pharmacokinetics of cerivastatin sodium. ERYTHROMYCIN: In hypercholesterolemic patients, steady-state cerivastatin AUC and Cmax increased approximately 50% and 24% respectively after 10 days with co-administration of erythromycin, a known inhibitor of cytochrome P450 3A4. OTHER CONCOMITANT THERAPY: Although specific interaction studies were not performed, in clinical studies, cerivastatin sodium was used concomitantly with angiotensin- converting enzyme (ACE) inhibitors, betablockers, calcium-channel blockers, diuretics, and nonsteroidal anti-inflammatory drugs (NSAIDs) without evidence of clinically significant adverse interactions. Chemical IUPAC Name 7-[4-(4-fluorophenyl)-5-(methoxymethyl)-2,6-bis(1-methylethyl)pyridin-3-yl]-3,5-dihydroxy-hept-6-enoicacid Chemical Formula C26H34FNO5 Half Life 2-3 hours Drug Type Approved Drug # Accession No APRD00102 CAS Registry Number 145599-86-6 |
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