|
Crestor 5mg, 10mg, 20mg and 40mg film-coated tablets(八)
llowed by 75 mg at 24 hours
20 mg, single dose
2-fold ↑
Gemfibrozil 600 mg BID, 7 days
80 mg, single dose
1.9-fold ↑
Eltrombopag 75 mg OD, 5 days
10 mg, single dose
1.6-fold ↑
Darunavir 600 mg/ritonavir 100 mg BID, 7 days
10 mg OD, 7 days
1.5-fold ↑
Tipranavir 500 mg/ritonavir 200 mg BID, 11 days
10 mg, single dose
1.4-fold ↑
Dronedarone 400 mg BID
Not available
1.4-fold ↑
Itraconazole 200 mg OD, 5 days
10 mg, single dose
**1.4-fold ↑
Ezetimibe 10 mg OD, 14 days
10 mg, OD, 14 days
**1.2-fold ↑
Fosamprenavir 700 mg/ritonavir 100 mg BID, 8 days
10 mg, single dose
↔
Aleglitazar 0.3 mg, 7 days
40 mg, 7 days
↔
Silymarin 140 mg TID, 5 days
10 mg, single dose
↔
Fenofibrate 67 mg TID, 7 days
10 mg, 7 days
↔
Rifampin 450 mg OD, 7 days
20 mg, single dose
↔
Ketoconazole 200 mg BID, 7 days
80 mg, single dose
↔
Fluconazole 200 mg OD, 11 days
80 mg, single dose
↔
Erythromycin 500 mg QID, 7 days
80 mg, single dose
20% ↓
Baicalin 50 mg TID, 14 days
20 mg, single dose
47% ↓
*Data given as x-fold change represent a simple ratio between co-administration and rosuvastatin alone. Data given as % change represent % difference relative to rosuvastatin alone.
Increase is indicated as “↑”, no change as “↔”, decrease as “↓”.
**Several interaction studies have been performed at different Crestor dosages, the table shows the most significant ratio
OD = once daily; BID = twice daily; TID = three times daily; QID = four times daily
Effect of rosuvastatin on co-administered medicinal products
Vitamin K antagonists: As with other HMG-CoA reductase inhibitors, the initiation of treatment or dosage up-titration of Crestor in patients treated concomitantly with vitamin K antagonists (e.g. warfarin or another coumarin anticoagulant) may result in an increase in International Normalised Ratio (INR). Discontinuation or down-titration of Crestor may result in a decrease in INR. In such situations, appropriate monitoring of INR is desirable.
Oral contraceptive/hormone replacement therapy (HRT): Concomitant use of Crestor and an oral contraceptive resulted in an increase in ethinyl estradiol and norgestrel AUC of 26% and 34%, respectively. These increased plasma levels should be considered when selecting oral contraceptive doses. There are no pharmacokinetic data available in subjects taking concomitant Crestor and HRT, therefore, a similar effect cannot be excluded. However, the combination has been extensively used in women in clinical trials and was well tolerated.
Other medicinal products:
Digoxin: Based on data from specific interaction studies no clinically relevant interaction with digoxin is expected.
Fusidic Acid: Interaction studies with rosuvastatin and fusidic acid have not been conducted. The risk of myopathy, including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins. The mechanism of this interaction (whether it is pharmacodynamic or pharmacokinetic, or both) is yet unknown. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination.
If treatment with systemic fusidic acid is necessary, Crestor treatment should be discontinued throughout the duration of the fusidic acid treatment. Also see section 4.4.
Paediatric population: Intera |
|
