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. Per 10/40 mg Ezetimibe 10 mg, simvastatin 40 mg. Per 10/80 mg Ezetimibe 10 mg, simvastatin 80 mg
Primary hypercholesterolemia: 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 & nonfamilial) hypercholesterolemia or mixed hyperlipidemia. Homozygous familial hypercholesterolemia (HoFH): Reduction of elevated total-cholesterol & LDL-cholesterol levels; as an adjunct to other lipid-lowering treatments (eg LDL apheresis) or if such treatments are unavailable.
Dosage/Direction for Use
Dose range: 10/10-10/80 mg/day. Initially 10/20 mg/day. Initiation of therapy w/ 10/10 mg/day may be considered for patients requiring less aggressive LDL-cholesterol reductions. Patients requiring a larger reduction in LDL-cholesterol (>55%) may be started at 10/40 mg/day. HoFH 10/40 or 10/80 mg/day in the evening. Patient w/ CKD & eGFR <60 mL/min/1.73 m2 10/20 mg once daily in the evening. Co-administration w/ other medicines Dosing of Vytorin should occur either ≥2 hr before or ≥4 hr after administration of a bile acid sequestrant. Patient on concomitant diltiazem, amiodarone, verapamil, elbasvir or grazoprevir Max: 10/20 mg/day. Patient on concomitant amlodipine Max: 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, gemfibrozil, cyclosporine or danazol. Pregnancy & lactation. Childn.
Special Precautions
Risk of myopathy/rhabdomyolysis. Perform liver function tests before initiating treatment & periodically thereafter (eg semi-annually) for the 1st yr of treatment. Discontinue if transaminase levels increase to 3x upper limit of normal. Concomitant fibrates. Substantial alcohol consumption &/or previous history of liver disease. Moderate or severe hepatic insufficiency. Monitor INR if administered w/ warfarin or other coumarin anticoagulants. Elderly.
Adverse Reactions
Increased ALT &/or AST, blood CK; myalgia.
Drug Interactions
Potent CYP3A4 inhibitors eg itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV-PIs, boceprevir, telaprevir, nefazodone or cobicistat; gemfibrozil, cyclosporine or danazol, amiodarone, cholestyramine, verapamil, diltiazem, amlodipine, fusidic acid, lomitapide; moderate CYP3A4 inhibitors, transport protein OATP1B1 inhibitors, colchicine, daptomycin, fibrates, niacin ≥1 g/day, grapefruit juice, coumarin derivatives.
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 10/40 mg tab
Vytorin 10/10 mg tab
Vytorin 10/20 mg tab
Vytorin 10/80 mg tab
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in