Primary hypercholesterolemia (type IIa) or combined dyslipidemia as an adjunct to diet & exercise when response is inadequate.
Dosage/Direction for Use
Initially 5 or 10 mg once daily in both statin naive patient or patient switched from another HMG-CoA reductase inhibitor, may be increased to the next dose level after 4 wk, if necessary. Patient w/ severe renal impairment (CrCl <30 mL/min/1.73 m2) not on hemodialysis Initially 5 mg once daily. Max: 10 mg once daily. Patient w/ liver impairment Max: 20 mg once daily.
Contraindications
Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation exceeding 3 times the upper limit of normal; myopathy. Concomitant use w/ cyclosporine. Pregnancy & lactation, women of childbearing potential w/o adequate contraception.
Special Precautions
Patients who consume excessive quantities of alcohol &/or have history of liver disease. Perform LFTs prior to initiation of therapy & 3 mth later. Monitor CK levels & INR. Report inexplicable muscle pain or weakness immediately, particularly if associated w/ malaise or fever. Patients w/ predisposing factors for myopathy/rhabdomyolysis. Avoid concomitant administration w/ gemfibrozil. May impair ability to drive or operate machinery. Elderly.
May result in an increase in INR w/ vit K antagonists eg, warfarin. Increased Cmax & AUC w/ gemfibrozil. Decreased plasma w/ concomitant use w/ antacids. Cmax & AUC may be decreased w/ erythromycin. OC may increase plasma levels.
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