Vytorin

Vytorin

ezetimibe + simvastatin

Manufacturer:

MSD International GmbH (SG)

Distributor:

Organon
Concise Prescribing Info
Contents
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
Indications/Uses
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, & 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.
Dosage/Direction for Use
Dose range of Ezetimibe/Simvastatin: Patient w/ primary or mixed hyperlipidemia 10/10-10/40 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/ HoFH Max daily dose: 10/40 mg in the evening. Patient taking lomitapide Max dose: 10/40 mg/day. Childn 10-17 yr Usual starting dose: 10/10 mg once daily in the evening. Dosing range: 10/10-10/40 mg/day. Co-administration w/ fenofibrate 10/10 mg or 10/20 mg/day, w/ bile sequestrant Take either ≥2 hr before or ≥4 hr after administration of a bile sequestrant, w/ amiodarone, verapamil or diltiazem Max daily dose: 10/20 mg, w/ amlodipine Max daily dose: 10/40 mg. Patient w/ CKD & GFR approx <60 mL/min/1.73 m2 10/20 mg once daily in the evening.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevation of serum transaminases. Concomitant use w/ fenofibrate; 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.
Special Precautions
Risk of myopathy, rhabdomyolysis (which may be due to interacting drugs that interfere w/ simvastatin metabolism &/or transporter pathway). Discontinue therapy immediately if myopathy is diagnosed or suspected. Consider periodic CK determinations in patients starting therapy or whose dose is being increased. Perform liver function tests before initiating treatment & periodically thereafter (eg, semi-annually) for the 1st yr of treatment. Alcoholism &/or previous history of liver disease. Monitor INR if administered w/ warfarin, another coumarin anticoagulant or fluindione. Severe renal insufficiency. Not recommended in patients w/ moderate to severe hepatic insufficiency. Not recommended in childn <10 yr. Elderly ≥65 yr. Asian patients.
Adverse Reactions
Increased ALT &/or AST, blood creatine kinase; myalgia.
Drug Interactions
Increased risk of myopathy/rhabdomyolysis w/ potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV-PIs, boceprevir, telaprevir or nefazodone & drugs containing cobicistat); gemfibrozil, cyclosporine, danazol; fusidic acid; amiodarone, Ca channel blockers (verapamil, diltiazem, amlodipine); lomitapide, moderate inhibitors of CYP3A4; breast cancer resistant protein inhibitors (eg, elbasvir, grazoprevir); niacin (≥1 g/day); daptomycin, colchicine; grapefruit juice. Drugs or herbals that inhibit certain enzymes eg, CYP3A4 &/or transporter eg, OATP1B. Fibrates (except fenofibrate). Decreased mean AUC w/ cholestyramine. Increased INR w/ coumarin anticoagulants (eg, warfarin, fluindione). Decreased absorption w/ antacids.
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.
Presentation/Packing
Form
Vytorin 10/10 mg tab
Packing/Price
30's (P1,587.3/pack)
Form
Vytorin 10/20 mg tab
Packing/Price
30's (P2,013/pack)
Form
Vytorin 10/40 mg tab
Packing/Price
30's (P2,873.2/pack)
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