Indication*

Decrease elevated total cholesterol (total-C), LDL-C & Triglycerides (TG) & increase HDL-C in adults with primary hypercholesterolemia (heterozygous familial & nonfamilial) or mixed dyslipidemia (Fredrickson types IIa & IIb). Decrease Apo B, non-HDL-C, VLDL-C, VLDL-TG, LDL-C/HDL-C, total-C/HDL, nonHDL-C/HDL-C & Apo B/Apo A-I in adults. Adults with isolated hypertriglyceridemia (Fredrickson type IV hyperlipidemia). Decreases total-C % LDL-C in adults with HoFH as adjunct to other lipid-lowering treatments (eg, LDL apheresis) or alone if such treatments are unavailable. Slows progression of atherosclerosis in adults as part of treatment strategy to decrease total-C & LDL-C to target levels. Decrease total-C, LDL-C & Apo B levels in children & adolescents 10-17 years (boys Tanner stage >II, & girls at least 1 year post-menarche) with heterozygous familial hypercholesterolemia if after adequate trial of diet therapy the following findings are present: LDL-C >90 mg/dL, or LDL-C >160 mg/dL & there is +ve family history of premature CV disease or >2 other CV risk factors are present in the patient. Decrease risk of stroke, MI & arterial revascularization procedures in individuals without clinically evident CHD but with increased risk of CV disease based on age (>50 year in men & >65 year women), hsCRP >2 mg/L, & presence of at least 1 additional CV disease risk factor eg, HTN, low HDL-C, smoking, or family history of premature CHD.

Directions for Use*

Adult dose range: 5-40 mg daily as single dose at any time of the day. Usual starting dose: 10-20 mg once daily. 40 mg dose is only recommended in patients with severe hypercholesterolemia at high CV risk (particularly with familial hypercholesterolemia), who do not achieve treatment goal using 20 mg dose, & in whom routine follow-up will be performed. Hyperlipidemia (including heterozygous familial hypercholesterolemia), mixed dyslipidemia, isolated hypertriglyceridemia, slowing of progression of atherosclerosis Initially 10 mg once daily. Severe hypercholesterolemia (including heterozygous familial hypercholesterolemia) 20 mg once daily. Primary prevention of CV disease 20 mg once daily. Children & adolescent 10-17 year Heterozygous familial hypercholesterolemia Initially 5 mg once daily. Usual dose range: 5-20 mg once daily. Adjustments should be made at intervals of >4 weeks. Max: 20 mg once daily. Patient with predisposing factors to myopathy, Asian patients & elderly >70 year Initially 5 mg once daily. Concomitant use with ciclosporin Limit dose to 5 mg once daily, gemfibrozil, lopinavir/ritonavir & atazanavir/ ritonavir Limit dose to 10 mg once daily. Renal impairment: Mild Usual dose range, moderate 5 mg once daily.

Administration*

May be taken with or without food.

*written indications, directions, and administration are updated as of March 14, 2024 and may not be accurate with the actual product purchased. Please read the details in the packaging.

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