Vytorin

Vytorin

simvastatin + ezetimibe

Manufacturer:

MSD

Distributor:

Zuellig Pharma
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
Prevention & risk reduction of CV disease in patients w/ CHD. Primary hypercholestrolemia, as adjunctive therapy to diet for reduction of elevated total-C, LDL-C, Apo B, triglycerides (TG), & non-HDL-C, & to increase HDL-C in adult & adolescent (10-17 yr) w/ primary (heterozygous familial & non-familial) hypercholesterolemia or mixed hyperlipidemia. In combination w/ fenofibrate for further reduction in TG & non-HDL-C & increase in HDL-C in adult patients w/ mixed hyperlipidemia. Homozygous familial hypercholesterolemia (HoFH), for reduction of elevated total-C & LDL-C levels in adult & adolescent (10-17 yr) w/ HoFH. Prevention & risk reduction of major CV events in patients w/ chronic kidney disease.
Dosage/Direction for Use
Individualized dosage. Patients w/ primary or mixed hyperlipidemia Dose range: 10/10 mg/day through 10/80 mg/day. Recommended starting dose: 10/20 mg/day. Patients requiring less aggressive LDL-C reductions Initially 10/10 mg/day. Patients requiring large reduction in LDL-C (>55%) May be started at 10/40 mg/day. Patients at high risk for CV complications Recommended dose: 10/80 mg. Patients w/ CHD 10/40 mg once daily in the evening. Patients w/ renal impairment/chronic kidney disease (GFR <60 mL/min/1.73 m2) 10/20 mg once daily in the evening. Coadministration w/ fenofibrate 10/10 mg/day or 10/20 mg/day. Patients w/ HoHF 10/40 mg/day or 10/80 mg/day in the evening. Coadministration w/ lomitapide or amlodipine Max: 10/40 mg/day. Coadministration w/ amiodarone, verapamil, diltiazem, or drugs containing elbasvir or grazoprevir Max: 10/20 mg/day. Ped patients (10-17 yr) Initially 10/10 mg daily in the evening. Dose range: 10/10 mg/day to max of 10/40 mg/day.
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 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.
Special Precautions
Risk of myopathy/rhabdomyolysis. Predisposing factors for myopathy including advanced age (≥65 yr), female gender, uncontrolled hypothyroidism, & renal impairment. Discontinue immediately if myopathy is diagnosed or suspected. Consider periodic CK determinations in patients starting treatment or whose dose is being increased especially to the 10/80 mg dose. Temporarily discontinue therapy a few days prior to elective major surgery & when any major medical or surgical condition supervenes. Asian patients. Perform liver function tests before treatment begins & thereafter; additional test prior to titration, 3 mth after titration to 10/80 mg dose, & periodically thereafter (eg, semiannually) for 1st yr of treatment. Patients who develop elevated serum transaminase levels. Discontinue treatment if transaminase levels rise to 3 x ULN & are persistent. Promptly interrupt therapy if serious liver injury &/or hyperbilirubinemia or jaundice occurs. Concomitant use w/ potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs, boceprevir, telaprevir, nefazodone or drug containing cobicistat); gemfibrozil, cyclosporine or danazol; fusidic acid; amiodarone; Ca channel blockers (eg, verapamil, diltiazem, amlodipine); lomitapide; moderate CYP3A4 inhibitors; breast cancer resistant protein (BCRP) inhibitors (eg, elbasvir & grazoprevir); fenofibrate; fibrates; niacin (≥1 g/day); daptomycin; anticoagulants (eg, warfarin). Alcoholics &/or patients w/ past history of liver disease. Moderate or severe hepatic insufficiency. Lactation. Patients <10 yr or pre-menarchal girls. Elderly ≥65 yr.
Adverse Reactions
Increased ALT &/or AST, increased blood CK; myalgia.
Drug Interactions
Increased risk of myopathy w/ potent inhibitors of CYP3A4 (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs, boceprevir, telaprevir, nefazodone or drugs containing cobicistat); fusidic acid; amiodarone; Ca channel blockers (eg, verapamil, diltiazem, or amlodipine); lomitapide; moderate CYP3A4 inhibitors; lipid-modifying doses of niacin (≥1 g/day); colchicine; HMG-CoA reductase inhibitors & daptomycin. Increased mean AUC & exposure of ezetimibe w/ cyclosporine. Increased cholesterol excretion into bile w/ fibrates (except fenofibrate). Decreased mean AUC of total ezetimibe w/ cholestyramine. Increased plasma conc of simvastatin & risk of myopathy w/ transport protein OATP1B1 & BCRP inhibitors. Increase mean AUC of niacin & nicotinuric acid. Increased plasma levels w/ grapefruit juice. Coumarin anticoagulants.
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 10/40 mg tab
Packing/Price
30's
Form
Vytorin 10/10 mg tab
Packing/Price
30's
Form
Vytorin 10/20 mg tab
Packing/Price
30's
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