Concise Prescribing Info
Reduce the risk of total mortality by reducing CHD deaths, risk of nonfatal MI & stroke; reduce risk for undergoing myocardial revascularisation procedures; slow progression of coronary atherosclerosis including reduction in the development of new lesions & new total occlusions. An adjunct to diet to reduce elevated total-C, LDL-C, TG & apolipoprotein B & to increase HDL-C in patients w/ primary hypercholesterolemia including heterozygous familial hypercholesterolemia (Fredrickson type IIa) or combined (mixed) hyperlipidemia (Fredrickson type IIb) when response to diet & other nonpharmacological measures is inadequate. Adjunct to diet & other nondietary measures for the treatment of patients w/ homozygous familial hypercholesterolemia to reduce total-C, LDL-C & apo B.
Dosage/Direction for Use
Patients at high risk of CHD or w/ existing CHD 20 mg daily as single dose. Patients w/ hyperlipidemia (not in the previous risk categories 10 mg daily as a single dose. Patients w/ homozygous familial hypercholesterolemia 40 mg daily or 80 mg daily in 3 divided doses.
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Hypersensitivity. Acute liver disease or unexplained persistent elevations of serum transaminases. Pregnancy & lactation.
Special Precautions
Myopathy/rhabdomyolysis. Perform baseline & periodic liver function tests. High alcohol consumption &/or past history of liver disease. Avoid concomitant fibrates or lipid lowering doses of nicotinic acid. Childn.
Adverse Reactions
Abdominal pain, constipation, flatulence; asthenia & headache. Rarely, myopathy.
Drug Interactions
Increase risk of myopathy/rhabdomyolysis w/ potent inhibitors of CYP3A4 (eg itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone); gemfibrozil, niacin & other fibrates; cyclosporine or danazol; amiodarone or verapamil; diltiazem. Increase the plasma levels of HMG-CoA reductase inhibitory activity w/ grapefruit juice. Potentiate the effect of coumarin anticoagulants.
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Apo-Simvastatin tab 10 mg
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