Vytorin

Reduction of risk of CV events (CV death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients w/ CHD; major CV events (nonfatal MI or cardiac death, stroke, or any revascularization procedure) in patients w/ CKD. Adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), LDL-C, apo B, triglycerides, & non-HDL-C, & to increase HDL-C in adult & adolescent 10-17 yr w/ primary heterozygous familial & non-familial hypercholesterolemia or mixed hyperlipidemia. Reduction of elevated total-C & LDL-C levels in adult & adolescent 10-17 yr w/ HoFH.

Patient w/ primary or mixed hyperlipidemia 10/10 mg-10/40 mg/day. Usual starting dose: 10/20 mg/day. Patients requiring larger reduction in LDL-C (>55%) may be started at 10/40 mg/day. Patient w/ CHD Starting dose: 10/40 mg once daily in the evening. Patient w/ CKD & estimated GFR <60 mL/min/1.73 m² 10/20 mg once daily in the evening. Patient w/ HoFH 10/40 mg/day in the evening. If concomitantly taking lomitapide, max of 10/40 mg/day. Ped 10-17 yr Starting dose: 10/10 mg once daily in the evening, max: 10/40 mg/day. Patient taking fenofibrate 10/10 mg/day or 10/20 mg/day. Patient taking amiodarone, verapamil, diltiazem, or products containing elbasvir or grazoprevir Should not exceed 10/20 mg/day. Patient taking amlodipine Should not exceed 10/40 mg/day.

May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Concomitant use w/ potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, HIV PIs, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone & drugs containing cobicistat); gemfibrozil, cyclosporine or danazol. Pregnancy & lactation. When co-administered w/ fenofibrate, refer to the package insert of fenofibrate.

Risk of myopathy/rhabdomyolysis; increased risk w/ drugs that interfere w/ simvastatin metabolism &/or transporter pathway. Discontinue therapy immediately if myopathy is diagnosed or suspected. Consider periodic creatine kinase determinations in patients starting therapy or whose dose is being increased. Reports of new onset or aggravated pre-existing myasthenia gravis or ocular myasthenia w/ statins. Perform LFTs before initiating treatment & thereafter when clinically indicated. Discontinue therapy in case of progressive & persistent rise in serum transaminase levels. Caution in patients who consume substantial quantities of alcohol &/or w/ previous history of liver disease. Monitor INR if administered w/ warfarin, another coumarin anticoagulant or fluindione. Closer monitoring in patients w/ renal insufficiency. Not recommended in patients w/ moderate to severe hepatic insufficiency. Not recommended in childn <10 yr. Caution in the elderly ≥65 yr & in Asian patients.

Increased ALT &/or AST, blood creatine kinase; myalgia.

Increased risk of myopathy/rhabdomyolysis w/ potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV-PIs, boceprevir, telaprevir, nefazodone & drugs containing cobicistat); gemfibrozil, cyclosporine, danazol; fusidic acid; amiodarone, Ca channel blockers (verapamil, diltiazem, amlodipine); lomitapide, moderate inhibitors of CYP3A4; OATP1B1 inhibitors; BCRP inhibitors (eg, elbasvir, grazoprevir); niacin (≥1 g/day); daptomycin, colchicine; grapefruit juice (in large quantities). Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. Decreased mean AUC of ezetimibe w/ cholestyramine. Increased INR w/ coumarin anticoagulants (eg, 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.

Rx