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See related Zocor tab information |
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Manufacturer |
MSD |
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Distributor |
Hong Kong: DKSH/Macau: Four Star |
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Contents |
Simvastatin |
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Indications |
Adjunct to diet for treatment of hypercholesterolaemia. Patients at high risk of CHD (w/ or w/o hypercholesterolaemia) including diabetics, those 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. |
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Dosage |
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 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. Concomitant therapy Patient taking cyclosporin, gemfibrozil, danazol or other fibrates (except fenofibrate) Max: 10 mg/day. Patient taking amiodarone or verapamil Max: 20 mg/day. Patient taking diltiazem Max: 40 mg/day. Severe renal insufficiency (CrCl <30 mL/min) Caution on dosage above 10 mg/day. |
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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. Hypersensitivity. |
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Special Precautions |
Risk of myopathy/rhabdomyolysis. Therapy should be temporarily stopped a few days prior to elective major surgery & when any major medical or surgical condition supervenes. Myopathy/rhabdomyolysis was observed when co-administered w/ lipid-modifying doses (≥1 g/day) of niacin. Elevations of serum transaminases. If level rises persistently to 3 times the upper limit of normal, discontinue the drug. Patients who consume substantial quantities of alcohol &/or have past history of liver disease. Childn. Elderly. Use in Chinese race w/ high dose (≥40 mg) concomitant w/ lipid-modifying doses (1 g/day) of niacin or niacin-containing prep may increase the incidence of myopathy. |
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Adverse Drug Reactions |
Abdominal pain, constipation, flatulence, asthenia & headache. Nausea, diarrhea, rash, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, memory impairment, insomnia, vomiting & anemia. Rarely, myopathy, rhabdomyolysis & hepatitis/jaundice, hypersensitivity syndrome.
View ADR Monitoring Form |
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Drug Interactions |
CYP3A4 inhibitors eg itraconazole, ketoconazole, erythromycin, telithromycin, clarithromycin, HIV-protease inhibitors, nefazodone, cyclosporine. Gemfibrozil, other fibrates, niacin. Amiodarone or verapamil, diltiazem, grapefruit juice, coumarin derivatives.
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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