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See related Zocor tab information |
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Manufacturer |
MSD |
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Distributor |
DKSH |
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Contents |
Simvastatin |
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Indications |
In CHD: Reduce risk of total mortality by reducing CHD deaths, reduce risk of major vascular & major coronary events, reduce risk of stroke, reduce the need for peripheral, other non-coronary & coronary revascularization procedures, reduce the risk of hospitalization for angina pectoris, slow progression of coronary atherosclerosis. In diabetics, reduce risk of developing peripheral macrovascular complications. In hyperlipidemia: Adjunct to diet to reduce elevated total-C, LDL-C, Apo B & TG, & to increase HDL-C in patients w/ primary hypercholesterolemia including heterozygous familial hypercholesterolemia or mixed hyperlipidemia. Adjunct to diet & other non-dietary measures to reduce elevated total-C, LDL-C & Apo B in homozygous familial hypercholesterolemia. Hypertriglyceridemia & primary dysbetalipoproteinemia. Ped patients w/ heterozygous familial hypercholesterolemia: Adjunct to diet to reduce total-C, LDL-C, TG & apo-B levels. |
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Dosage |
Dosage range: 5-80 mg/day as a single dose in the evening. Adjust at 4-wk interval to a max of 80 mg/day. Patients at high risk of CHD or w/ existing CHD Usual starting dose: 40 mg/day as a single dose in the evening. Hyperlipidemia Usual starting dose: 20 mg/day as a single dose in the evening. Patients who require a large reduction in LDL-C (>45%) Initially 40 mg/day as a single dose in the evening. Homozygous familial hypercholesterolemia 40 mg/day in the evening or 80 mg/day in 3 divided doses. Heterozygous familial hypercholesterolemia Childn 10-17 yr Usual starting dose: 10 mg/day in the evening. Max: 40 mg/day. Concomitant therapy w/ cyclosporine, danazol, gemfibrozil, other fibrates (except fenofibrate) Max: 10 mg/day. W/ amiodarone or verapamil Max: 20 mg/day. W/ diltiazem Max: 40 mg/day. Renal impairment (CrCl <30 mL/min) >10 mg/day should be carefully considered. |
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Administration |
May be taken with or without food (Avoid excessive consumption (>1 L/day) of grapefruit juice.). |
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Contraindications |
Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy & lactation. |
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Special Precautions |
Myopathy or rhabdomyolysis. Discontinue if muscle symptoms &/or marked elevation of CPK levels occur & transaminase level rises persistently to 3 times the upper limit of normal. Liver function tests recommended before treatment begins & periodically thereafter (eg semi-annually) for the 1st yr of treatment or until 1 yr after the last elevation in dose in all patients. Patients who consume substantial amount of alcohol &/or have a history of liver disease. |
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Adverse Drug Reactions |
Abdominal pain, flatulence, constipation, asthenia, headache, nausea, diarrhea, rash, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, memory impairment, insomnia, vomiting, anemia. Rarely, rhabdomyolysis, hepatitis or jaundice, hypersensitivity syndrome.
View ADR Monitoring Form |
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Drug Interactions |
Use w/ caution w/ coumarin anticoagulants & in combination w/ cyclosporine, danazol, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, fibrates (except fenofibrate), niacin (≥1 g/day), amiodarone, verapamil, diltiazem, amlodipine, fusidic acid, grapefruit juice (>1 L/day).
View more drug interactions with Zocor |
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Pregnancy Category (US FDA) |
Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. |
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