Primary hypercholesterolemia, reduction of elevated LDL-C, total cholesterol, triglycerides & Apo B & increase in HDL-C. HoFH as an adjunct to diet & other lipid-lowering treatment (eg, LDL aphaeresis).
Dosage/Direction for Use
Initially 5 or 10 mg once daily. May be adjusted to the next dose level after 4 wk, if necessary.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation >3 x ULN; myopathy; concomitant cyclosporine therapy. Women of childbearing potential who do not use appropriate contraception, pregnancy & lactation.
Special Precautions
Proteinuria; myalgia, myopathy. Patients w/ predisposing factors for myopathy/rhabdomyolysis. Renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels may occur, concomitant use of fibrates. Patients at high risk for developing diabetes; Asian patients. May impair ability to drive or operate machinery. Pregnancy & breastfeeding. Childn. Elderly >70 yr.
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