simvastatin + ezetimibe




Zuellig Pharma
Concise Prescribing Info
Per 10/10 mg Ezetimibe 10 mg, simvastatin 10 mg. Per 10/20 mg Ezetimibe 10 mg, simvastatin 20 mg
Adjunctive therapy to diet for the reduction of elevated total-cholesterol, LDL-cholesterol, apolipoprotein B, triglycerides & non-HDL-cholesterol, & to increase HDL-cholesterol in patients w/ primary (heterozygous familial & non-familial) hypercholesterolemia or mixed hyperlipidemia.
Dosage/Direction for Use
Individualized dosage. Initially 10/20 mg daily. Patient requiring less aggressive LDL-cholesterol reductions Initially 10/10 mg daily may be considered. Patient w/ chronic kidney disease & estimated GFR <60 mL/min/1.73 m2 10/20 mg daily in the evening. Patient taking amiodarone, verapamil, diltiazem, elbasvir or grazoprevir Max: 10/20 mg daily.
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Hypersensitivity. Active liver disease or unexplained persistent serum transaminase elevations. Concomitant administration w/ potent CYP3A4 inhibitors, gemfibrozil, cyclosporine, danazol. Pregnancy & lactation.
Special Precautions
Risk of myopathy/rhabdomyolysis. Not recommended to be co-administered w/ fusidic acid, niacin (≥1 g daily in Asian patients). Avoid concomitant use w/ fibrates. Concomitant use w/ amiodarone, verapamil, diltiazem, amlodipine, lomitapide, moderate CYP3A4 inhibitors, breast cancer resistant protein (BCRP) inhibitors, daptomycin. Perform liver function tests before treatment & thereafter when clinically indicated. Discontinue use if transaminase levels show evidence of progression, particularly if it rises to 3x upper limit of normal & are persistent. Promptly interrupt therapy if serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs. Substantial alcohol consumption &/or past history of liver disease. Not recommended in patients w/ moderate or severe hepatic insufficiency. Appropriately monitor INR if Vytorin is added to warfarin, another coumarin anticoagulant, or fluindione. Not recommended for ped patients. Elderly ≥65 yr.
Adverse Reactions
Increased ALT &/or AST, blood creatine kinase; myalgia.
Drug Interactions
May increase simvastatin plasma conc & may lead to increased risk of myopathy w/ transport protein OATP1B inhibitors; BCRP inhibitors (eg, elbasvir, grazoprevir). Increased risk of myopathy in concomitant use w/ potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV-PIs, boceprevir, telaprevir, nefazodone, cobicistat). Concomitant use is contraindicated w/ gemfibrozil, cyclosporine or danazol. Risk of myopathy may be increased by moderate CYP3A4 inhibitors. Cholesterol excretion into the bile may be increased by fibrates, leading to cholelithiasis. May increase risk of myopathy/rhabdomyolysis by fusidic acid; lomitapide. Increased risk of myopathy/rhabdomyolysis by amiodarone; verapamil, diltiazem, amlodipine; niacin (≥1 g daily); daptomycin. Decreased mean AUC of ezetimibe by cholestyramine. Possible myopathy/rhabdomyolysis in patients w/ renal insufficiency when concomitantly administered w/ colchicine. HMG-CoA reductase inhibitory activity may significantly be increased by grapefruit juice (large quantities). Modestly potentiated coumarin anticoagulants effects by simvastatin.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10BA02 - simvastatin and ezetimibe ; Belongs to the class of HMG CoA reductase inhibitors in combination with other lipid modifying agents. Used in the treatment of hyperlipidemia.
Vytorin 10/10 mg tab
Vytorin 10/20 mg tab
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