Monotherapy or co-administered w/ HMG-CoA reductase inhibitor, as adjunctive therapy to diet in patients w/ primary (heterozygous familial & non-familial) hypercholesterolaemia who are not appropriately controlled w/ statin alone. Co-administered w/ a statin, as adjunctive therapy to diet in patients w/ homozygous familial hypercholesterolaemia.
Dosage/Direction for Use
10 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. When co-administered w/ a statin: Pregnancy & lactation; patients w/ active liver disease or unexplained persistent elevations in serum transaminases.
Special Precautions
When co-administered w/ a statin, perform liver function tests at initiation of therapy. Increased risk of rhabdomyolysis & myopathy. Discontinue therapy if cholelithiasis is suspected. Monitor concentrations of ciclosporin prior to therapy. Monitor INR if co-administered w/ warfarin & other coumarin anticoagulant or fluindione. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Moderate or severe hepatic impairment. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn (10-17 yr).
Decreased rate of absorption w/ antacids. Decreased mean AUC w/ cholestyramine. Increased risk of cholelithiasis & gallbladder disease w/ fibrates. Increased conc w/ fenofibrate or gemfibrozil. Exercise caution when using w/ ciclosporin, warfarin, another coumarin anticoagulant or fluindione.
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