Cerivastatin drug interactions

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-632-7753

List of drug interactions

Rhabdomyolysis

Other drug interactions

• Antacid (magnesium-aluminum hydroxide)
• Cimetidine
• Cholestyramine
• Digoxin
• Warfarin
• Erythromycin
• Itraconazole
• Omeprazole
• Gemfibrozil
• Cyclosporine

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Rhabdomyolysis

Cases of rhabdomyolysis, some with acute renal failure secondary to myoglobinuria, have been reported with cerivastatin and other drugs in this class with use of immunosuppressive drugs, fibric acid derivatives, niacin (nicotinic acid), erythromycin, azole, and antifungals. Return to top

Other drug interactions

Antacid (magnesium-aluminum hydroxide)

Cerivastatin plasma concentrations were not affected by co-administration of antacid. Return to top

Cimetidine

Cerivastatin plasma concentrations were not affected by co-administration of cimetidine. Return to top

Cholestyramine

The influence of the bile-acid-sequestering agent cholestyramine on the pharmacokinetics of cerivastatin sodium was evaluated in 12 healthy males in 2 separate randomized crossover studies. 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. Return to top

Digoxin

Plasma digoxin levels and digoxin clearance at steady-state were not affected by coadministration of 0.2 mg cerivastatin sodium. Cerivastatin plasma concentrations were also not affected by co-administration of digoxin. Return to top

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. Return to top

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. Return to top

Itraconazole

In hypercholesterolemic patients, following a 0.3 mg dose of cerivastatin, steady-state cerivastatin AUC and Cmax increased 38% and 12%, respectively after 10 days with co-administration of 200 mg itraconazole, a potent inhibitor of cytochrome P450 3A4. Cerivastatin half-life was approximately 5 hours (a 64% increase) following co-administration with itraconazole, which would not lead to accumulation of cerivastatin upon multiple dosing. The administration of 0.3 mg of cerivastatin concomitantly with itraconazole has no effect on itraconazole pharmacokinetics.
In a single dose crossover study using 0.8 mg cerivastatin, the AUC and Cmax of cerivastatin were increased 27% and 25% respectively during concomitant itraconazole treatment. Return to top

Omeprazole

There were no changes in the pharmacokinetic parameters of either cerivastatin or its major active metabolites, or of omeprazole in healthy young males given single 0.3 mg oral doses of cerivastatin alone or on the fifth day of a five-day omeprazole 20 mg daily pre-treatment. Return to top

Gemfibrozil

The potential for clinically relevant interaction between gemfibrozil and cerivastatin has not been assessed in clinical trials. However, during postmarketing surveillance, patients on cerivastatin who experienced rhabdomyolysis and associated renal failure, were in most cases also taking gemfibrozil. Return to top

Cyclosporine

The single dose pharmacokinetics of 0.2 mg of cerivastatin in healthy subjects was compared to the pharmacokinetics of single and multiple doses in renal transplant patients who were at steady-state with respect to cyclosporine. Cyclosporine levels were unaffected by cerivastatin. Plasma concentrations of cerivastatin and its metabolites increased 3- to 5-fold with no change in its elimination.
No cerivastatin accumulation occurred with multiple dosing. Return to top

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The content of this page is taken from the FDA package insert for this drug and should not be edited.