Adjunct to diet for treatment of hypercholesterolaemia. Risk reduction of CV death, major CV events including stroke, & hospitalisation due to angina pectoris in patients at high risk of CHD (w/ or w/o hypercholesterolaemia) including patients w/ diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or w/ existing CHD. Adjunct to diet to reduce total-cholesterol, LDL-C & Apo B levels in adolescents who are at least 1 yr post-menarche, 10-17 yr, w/ heterozygous familial hypercholesterolemia, if after an adequate trial of diet therapy the following findings are present: LDL-C remains ≥190 mg/dL (4.9 mmol/L); or LDL-C remains ≥160 mg/dL (4.1 mmol/L) & there is a +ve family history of premature CVD or ≥2 other CVD risk factors are present in the adolescent patient.
10-80 mg/day as a single dose in the evening. Adjustments should be made at intervals of not <4 wk. Max: 80 mg/day. Existing CHD or high risk of CHD Initially 40 mg/day as a single dose in the evening. Hypercholesterolaemia & combined hyperlipidaemia Initially 10-20 mg/day in the evening, then individualise according to patient's response. Patient taking fibrates (other than gemfibrozil or fenofibrate), verapamil or diltiazem Max: 10 mg/day. Patient taking amiodarone, amlodipine, niacin, ranolazine, or elbasvir- or grazoprevir-containing products Max: 20 mg/day. Patient w/ severe renal impairment (CrCl <30 mL/min) Carefully consider dose >10 mg/day, & implement cautiously if deemed necessary. Adolescent 10-17 yr w/ heterozygous familial hypercholesterolemia Initially 10 mg once daily in the evening. Max: 40 mg/day.
View Zocor overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Avoid grapefruit juice.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Concomitant administration of potent CYP3A4 inhibitors, gemfibrozil, cyclosporine or danazol. Pregnancy & lactation.
Risk of myopathy/rhabdomyolysis. Promptly report any unexplained muscle pain, tenderness or weakness. Periodic creatine kinase (CK) determinations may be considered in patients starting therapy w/ simvastatin or whose dose is being increased. Risk of persistent increases (>3x ULN) in serum transaminases. Perform LFTs before treatment initiation & thereafter when clinically indicated. Reports of elevated alkaline phosphatase & γ-glutamyl transpeptidase; increases in serum CK levels; increases in HbA1c & fasting serum glucose levels. Caution in patients who consume substantial quantities of alcohol &/or have a past history of liver disease; patients w/ impaired renal function. Has not been studied in patients <10 yr, nor in pre-menarchal girls. Possible increased risk of myopathy in patients ≥65 yr treated w/ simvastatin 80 mg/day.
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