Adjunct to diet for reduction of elevated total-cholesterol, LDL-cholesterol, apolipoprotein B or triglycerides in patients w/ primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia or mixed hyperlipidaemia (Frederickson types IIa & IIb), when adequate response from diet & other non-pharmacological measures are not obtained. Combination therapy for reduction of total-cholesterol & LDL-cholesterol in patients w/ homozygous familial hypercholesterolaemia, when adequate response from diet & other non-pharmacological measures are not obtained.
Dosage/Direction for Use
Initially 10 mg/day. Adjust dose at ≥4-wk interval. Max: 80 mg/day. Heterozygous familial hypercholesterolaemia Initially 10 mg/day. Adjust dose at 4-wk interval up to 40 mg/day. May be increased to max of 80 mg/day or 40 mg/day in combination w/ a bile acid sequestrant. Homozygous familial hypercholesterolaemia 80 mg/day.
May be taken with or without food.
Active liver disease or unexplained persistent elevation of serum transaminase level >3 times ULN. Myopathy. Pregnancy & lactation.
Perform liver function tests before initiation of treatment & periodically thereafter. Patient who consume substantial amounts of alcohol. History of liver disease. Predisposition to rhabdomyolysis. Childn.