Agencia Lei Va Hong


A. Menarini
Concise Prescribing Info
Adjunct to diet for treatment of hypercholesterolaemia. Patients at high risk of CHD (w/ or w/o hypercholesterolaemia) including diabetics, patients w/ history of stroke or other cerebrovascular disease, peripheral vessel disease, or w/ existing CHD to reduce the risk of CV death, major CV events including stroke, & hospitalisation due to angina pectoris. Adjunct to diet to reduce total-cholesterol, LDL-cholesterol (LDL-C) & apolipoprotein 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 positive family history of premature CVD or ≥2 other CVD risk factors are present in the adolescent patient.
Dosage/Direction for Use
10-80 mg/day as a single dose in the evening. Adjustments should be made at intervals of not less than 4 wk. Max: 80 mg/day. Patient at high risk of CHD or w/ existing CHD Initially 40 mg/day as a single dose in the evening. Hypercholesterolaemia & combined hyperlipidaemia Initially 10-20 mg/day in the evening then individualised according to patient's response. Patient taking verapamil or diltiazem, fibrates other than gemfibrozil or fenofibrate Max: 10 mg/day. Patient taking amiodarone, amlodipine, niacin, ranolazine or products containing elbasvir or grazoprevir Max: 20 mg/day. Severe renal insufficiency (CrCl <30 mL/min) Caution on dosage above 10 mg/day. Adolescent 10-17 yr w/ heterozygous familial hypercholesterolemia Initially 10 mg once daily in the evening. Max: 40 mg/day.
May be taken with or without food: Avoid grapefruit juice.
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Concomitant administration of potent CYP3A4 inhibitors, gemfibrozil, cyclosporine or danazol. Pregnancy & lactation.
Special Precautions
Risk of myopathy/rhabdomyolysis. Report promptly 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. Reports of persistent elevations (>3x ULN) of serum transaminases. Perform liver function tests before treatment initiation & thereafter when clinically indicated. Use w/ caution in patients who consume substantial quantities of alcohol &/or have a past history of liver disease. Reports of elevated alkaline phosphatase & γ-glutamyl transpeptidase; increases in serum CK levels; increases in HbA1c & fasting serum glucose levels. Patients w/ impaired renal function. Childn <10 yr. Pre-menarchal girls. Elderly.
Adverse Reactions
Abdominal pain, constipation, flatulence, asthenia & headache. Nausea, diarrhea, rash, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, insomnia, depression, vomiting, anemia, erectile dysfunction, interstitial lung disease.
Drug Interactions
Increased risk of myopathy/rhabdomyolysis w/ potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs, boceprevir, telaprevir, nefazodone, & cobicistat-containing drugs); gemfibrozil, cyclosporine or danazol; other fibrates (except fenofibrate), fusidic acid; amiodarone; Ca channel blockers (eg, verapamil, diltiazem, or amlodipine); moderate CYP3A4 inhibitors; BCRP inhibitors (eg, elbasvir or grazoprevir); niacin/nicotinic acid (≥1 g/day); colchicine; daptomycin; grapefruit juice. Potentiated effect of coumarin anticoagulants.
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
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