Adjunct to diet for the reduction of elevated total cholesterol, LDL cholesterol, Apo B & triglycerides in patients w/ primary hypercholesterolemia, combined or mixed hyperlipidemia, heterozygous & homozygous familial hypercholesterolemia when diet response & nonpharmacological measures are inadequate. Prevention of CV complications.
Dosage/Direction for Use
Usual dose: 10 mg once daily. Range: 10-80 mg once daily. Primary hypercholesterolemia & combined or mixed hyperlipidemia 10 mg daily for 2 wk & up to 4 wk for max response. Homozygous familial hypercholesterolemia 80 mg. Heterozygous familial hypercholesterolemia in ped patients 10-17 yr 10 mg daily. Max: 20 mg daily. Dose adjustment should be made at ≥4 wk intervals.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Active liver disease or unexplained persistent serum transaminases elevation ≥3 x ULN. Pregnancy, women of childbearing potential & lactation.
Special Precautions
Perform LFT prior initiation, 12 wk after, during evaluation of dose & periodically thereafter; patient w/ diffuse myalgias, muscle tenderness or weakness &/or marked elevation of CPK. Promptly report unexplained muscle pain, tenderness or weakness, especially if accompanied w/ malaise or fever. Discontinue use in case of markedly elevated CPK levels, diagnosed or suspected myopathy or w/ risk factor to development of renal failure secondary to rhabdomyolysis.
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