Each tablet contains Simvastatin 5 mg/10 mg/20 mg.
Indicated in Primary hypercholesterolemia, type IIa & IIb alone or in association with CAD.
Simvastatin is a specific inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme which catalyzes the conversion of HMG-CoA to mevalonate. However, at therapeutic doses, the enzyme is not completely blocked, thereby allowing biologically necessary amounts of mevalonate to be available.
The dosage range is 5-80 mg/day. In patients with Coronary Heart Disease (CHD) or at high risk of CHD, the recommended usual starting dose is 20 to 40 mg once a day in the evening.
Contraindicated in patients with known hypersensitivity to the drug, active liver disease, women who are pregnant or may become pregnant and nursing mothers.
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses and concomitant use of certain CYP3A4 inhibitors, gemfibrozil, cyclosporine, danazol, amiodarone, and verapamil. Predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminase can occur. Monitor liver enzymes before and during treatment.
Contraindicated in pregnancy and lactation. There are no adequate and well-controlled studies in children.
Simvastatin, like several other inhibitors of HMG-CoA reductase, is a substrate of CYP3A4. Avoid concomitant administration of simvastatin with CPY3A4 inhibitors like itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, and nefazodone due to increased risk of myopathy and rhabdomyolysis. Coumarin anticoagulants: Concomitant use with simvastatin prolongs INR. Achieve stable INR prior to starting simvastatin.
Most common adverse reactions are: upper respiratory infection, headache, abdominal pain, constipation and nausea.
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