Vytorin

Per 10/10 mg tab Ezetimibe 10 mg, simvastatin 10 mg. Per 10/20 mg tab Ezetimibe 10 mg, simvastatin 20 mg. Per 10/40 mg tab Ezetimibe 10 mg, simvastatin 40 mg

Reduce risk of CV events (CV death, nonfatal MI & stroke, hospitalization for unstable angina or need for revascularization) in patients w/ CHD & history of acute coronary syndrome either previously treated w/ statin or not. Adjunctive therapy to diet for reduction of elevated total cholesterol (total-C), LDL-C, Apo B, triglycerides & non-HDL-C & to increase HDL-C in patients w/ primary (heterozygous familial & non-familial) hypercholesterolemia or mixed hyperlipidemia. Reduction of elevated total-C & LDL-C levels in patients w/ HoFH.

Primary hypercholesterolemia or mixed hyperlipidemia Dose range: 10/10-10/80 mg daily. Initially 10/20 mg daily. Patient requiring less aggressive LDL-C reduction Initially 10/10 mg daily. Patient requiring larger LDL-C reduction Initially 10/40 mg daily. Patient at high risk for CV complications 10/80 mg daily. CHD 10/40 mg once daily in the evening. HoFH 10/40 or 10/80 mg daily in the evening. Concomitant use w/ lomitapide Not to exceed 10/40 mg daily. Co-administration w/ bile acid sequestrants Administer either ≥2 hr prior or 4 hr after. Concomitant use w/ amiodarone, verapamil, diltiazem, elbasvir- or grazoprevir-containing products Not to exceed 10/20 mg daily. Concomitant use w/ amlodipine Not to exceed 10/40 mg daily.

May be taken with or without food.

Hypersensitivity. Concomitant use of potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, HIV PIs, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, cobicistat-containing drugs), gemfibrozil, cyclosporine, danazol. Active liver disease or unexplained persistent serum transaminases elevation. Pregnancy & lactation.

Discontinue use if myopathy is diagnosed or suspected; induce new onset or aggravate pre-existing myasthenia gravis or ocular myasthenia; serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs. Immune-mediated necrotizing myopathy. Substantial alcohol consumption &/or history of liver disease. Temporarily discontinue use prior to elective major surgery, when major medical or surgical condition supervenes. Perform LFTs prior to & 3 mth after titration & periodically thereafter. Asian patients. Avoid use w/ other fibrates. Not recommended in concomitant use w/ fusidic acid. Concomitant use w/ potent & moderate CYP3A4 inhibitors, gemfibrozil, cyclosporine, danazol, amiodarone, Ca-channel blockers, lomitapide, BCRP inhibitors, niacin ≥1 g daily, daptomycin, anticoagulants. Allow either 2 hr before or 4 hr after administration of a bile acid sequestrant. Not recommended moderate or severe hepatic insufficiency. Severe renal insufficiency (CrCl ≤30 mL/min). Not to be used during pregnancy & lactation. Not recommended in ped patients. Elderly ≥65 yr.

Increased ALT &/or AST, blood CK; myalgia.

Increased risk of myopathy w/ potent (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs, boceprevir, telaprevir, nefazodone, cobicistat-containing drugs) & moderate CYP3A4 inhibitors, fusidic acid, amiodarone, Ca-channel blockers, lomitapide, niacin ≥1 g daily, colchicine, daptomycin. Increased total conc w/ gemfibrozil. Increased mean AUC w/ cyclosporine. Severe myositis w/ myoglobinuria & increased cholesterol excretion w/ fibrates. Decreased mean AUC w/ cholestyramine. Increased plasma conc w/ OATP1B1 transporter & BCRP inhibitors, grapefruit juice. Increased INR w/ warfarin, fluindione.

Dyslipidaemic Agents

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.

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