In combination w/ an HMG-CoA reductase inhibitor (statin) or alone, as an adjunct to diet for the reduction of elevated total-cholesterol, LDL-cholesterol, apolipoprotein B & triglycerides & to increase HDL-cholesterol in patients w/ primary hypercholesterolemia. In combination w/ fenofibrate, as adjunctive therapy to diet for the reduction of elevated total-cholesterol, LDL-colesterol, apolipoprotein B & non-HDL-cholesterol in mixed hyperlipidemia. Reduction of risk of CV events in patients w/ CHD & history of acute coronary syndrome when added to ongoing statin therapy or initiated concomitantly w/ a statin. In combination w/ a statin for the reduction of elevated total-cholesterol & LDL-cholesterol levels in patients w/ homozygous familial hypercholesterolemia. Reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial sitosterolemia.
Patient ≥10 yr 10 mg once daily used alone, w/ a statin, or w/ fenofibrate. Dosing should occur ≥2 hr before or ≥4 hr after co-administration w/ bile acid sequestrants. Patient w/ CHD & acute coronary syndrome event history
10 mg may be administered w/ a statin w/ proven CV benefit.
When co-administered w/ a statin, perform liver function tests at initiation of therapy & according to the recommendations of the statin. Avoid in moderate to severe hepatic insufficiency. Avoid co-administration w/ fibrates. Ezetrol & any statin taken concomitantly should be discontinued if myopathy is diagnosed or suspected. Cyclosporine. Monitor INR w/ warfarin or another coumarin anticoagulant. Not recommended in patients w/ moderate or severe liver dysfunction. Pregnancy & lactation. Not recommended in childn <10 yr.
Abdominal pain, diarrhea, flatulence; general disorders & administration site condition eg, fatigue. W/ statin: Headache, increased ALT &/or AST, myalgia. W/ fenofibrate: Abdominal pain.
Drug Interactions
Decreased mean AUC w/ cholestyramine. Increased mean AUC w/ cyclosporine. Concomitant use w/ fibrates may increase cholesterol excretion into the bile. Concomitant use w/ warfarin may increase INR.
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