Adjunct to diet for the reduction of elevated total cholesterol (total-C), LDL-C, apo-B & triglycerides in patients w/ primary hypercholesterolemia, combined (mixed) hyperlipidemia & heterozygous & homozygous familial hypercholesterolemia when diet response & other nonpharmacological measures are inadequate. Hypertensive patient (≥40 yr) & dyslipidemia w/ at least 3 risk factor for future CV events eg, LVH, ECG abnormalities, NIDDM, peripheral vascular disease, post-history of cerebrovascular events eg, TIA ≥3 mth previously, microalbuminaria/proteinuria, smoking (regular smoker w/in the last yr of 20 cigarettes or cigars/wk), TC/HDL-C ratio 6 & history of CAD event in 1st degree relative before age 55 (males) or 60 (women). Reduced risk of fatal CHD & non-fatal MI, stroke & revascularization procedures & angina pectoris. Adjunct to diet to reduce total-C, LDL-C & Apo B levels in boys & postmenarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia if after adequate diet therapy LDL-C remains ≥190 mg/dL or ≥160 mg/dL & there is +ve family history of premature CV disease or ≥2 other CV disease risk factors.
Dosage/Direction for Use
Usual dose: 10 mg once daily. Dose range: 10-80 mg daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg. Heterozygous hypercholesterolemia in childn 10-17 yr Initially 10 mg daily. Max dose: 20 mg daily. Dose adjustment should be made at intervals of ≥4 wk.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3 x ULN. Pregnancy & lactation.
Special Precautions
Perform LFT prior to treatment. Patients w/ myalgia; suffering from unexplained muscle pain, tenderness or weakness especially those accompanied w/ malaise or fever. Women of childbearing potential.
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