Reduction of LDL-cholesterol (LDL-C) apolipoprotein B & triglycerides & to increase HDL-cholesterol (HDL-C) in the treatment of hyperlipidemias. As adjunctive therapy in patients w/ homozygous familial hypercholesterolemia who have some LDL-receptor function & for primary prophylaxis of CV events in patients w/ multiple risk factors.
Dosage/Direction for Use
10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg w/ >15% reduction in LDL-C.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Women of childbearing potential. Pregnancy & lactation.
Special Precautions
History of liver disease. Consumption of substantial quantities of alcohol. Perform liver function tests prior to & 12 wk following initiation of therapy & periodically thereafter. Rare cases of rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Discontinue use if markedly elevated creatine phosphokinase levels occurs or myopathy is diagnosed or suspected. Concomitant use w/ ketoconazole, spironolactone & cimetidine. Discontinue or temporary withheld in patients w/ severe acute infection, hypotension, major surgery, trauma, metabolic, endocrine & electrolyte disorders & uncontrolled seizures. Childn <18 yr.
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