Rosetta Drug Interactions

Rosuvastatin is minimally (approximately 10%) metabolized by cytochrome P 450 (CYP) isoenzyme 2C9. Clearance of rosuvastatin is not dependent on metabolism by CYP 3A4 to a clinically important extent.
Antacid: The simultaneous dosing of rosuvastatin (40 mg as a single dose) with an antacid suspension containing aluminium hydroxide and magnesium hydroxide resulted in a decrease in rosuvastatin C_max and AUC by 50 and 54%, respectively. This effect was mitigated when the antacid was dosed 2 hours after rosuvastatin. Therefore, if rosuvastatin and aluminium- magnesium hydroxide antacid are used concomitantly, the antacid should be administered at least 2 hours after rosuvastatin.
Cyclosporine: Concomitant use of rosuvastatin and cyclosporine may increase the risk of myopathy. Following concomitant treatment with rosuvastatin and cyclosporine, rosuvastatin C_max and AUC values were increased by 11- and 7.1- fold, respectively. Side effects were considered clinically important and concomitant use is contraindicated.
Digoxin: Concomitant use of rosuvastatin and digoxin increased both C_max and AUC of digoxin by 4%. Based on data from specific interaction studies, no clinically relevant interactions are expected.
Erythromycin: Concomitant use of rosuvastatin and erythromycin resulted in a 20% decrease in AUC and a 30% decrease in C_max of rosuvastatin.
Fibric acid derivatives: Fenofibrate: Concomitant use of rosuvastatin and fenofibrate may increase the risk of myopathy. Caution is advised if rosuvastatin is used concomitantly with fenofibrate.
Gemfibrozil: Concomitant use of rosuvastatin and gemfibrozil may increase the risk of myopathy and should be avoided. Concomitant use resulted in a 2-fold increase in rosuvastatin C_max and AUC. If used concomitantly with gemfibrozil, dosage of rosuvastatin should not be exceed 10 mg once daily.
HIV Protease inhibitors: Strongly increase rosuvastatin exposure. Caution is advised if these drugs are used concomitantly.
Niacin: Concomitant use of rosuvastatin and antilipemic dosages (1 g daily or higher) of niacin may increase the risk of myopathy. Caution is advised if rosuvastatin is used concomitantly with antilipemic dosages of niacin.
Oral contraceptive: Concomitant use of rosuvastatin and an oral contraceptive (ethinyl estradiol and norgestrel) resulted in an increase in ethinyl estradiol and norgestrel AUC of 26% and 34%, respectively.
Warfarin: Rosuvastatin potentiate the effects of coumarin-derivative anticoagulants in prolonging prothrombin time (PT)/international normalized ratio (INR); the drug has been shown to substantially increase INR in patients receiving coumarin anticoagulants. Caution should be exercised when rosuvastatin is used concomitantly with anticoagulants. INR should be stable prior to initiating rosuvastatin and should be monitored frequently enough during early therapy or following rosuvastatin dosage adjustment.