simvastatin + ezetimibe




Agencia Lei Va Hong


Concise Prescribing Info
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
Risk reduction of CV events in patients w/ CHD & history of acute coronary syndrome (ACS), either previously treated w/ statin or not. Adjunctive therapy to diet in patients w/ primary (heterozygous familial & non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of combination product is appropriate: patients not appropriately controlled w/ statin alone or patients already treated w/ a statin & ezetimibe. Adjunctive therapy to diet in patients w/ homozygous familial hypercholesterolaemia (HoFH).
Dosage/Direction for Use
Hypercholesterolaemia Individualized dosage ranging from 10/10 mg to 10/80 mg/day. Usual dose: 10/20 mg or 10/40 mg/day as a single dose in the evening. Dosage adjustment should be made at not less than 4-wk intervals. CHD, ACS event history Starting dose: 10/40 mg once daily in the evening. HoFH Starting dose: 10/40 mg once daily in the evening. In patients taking lomitapide concomitantly, the dose must not exceed 10/40 mg/day. Co-administration w/ other medicines Dosing of Vytorin should occur either ≥2 hr before or ≥4 hr after administration of a bile acid sequestrant. In patients on concomitant verapamil or diltiazem, the dose should not exceed 10/10 mg/day. In patients on concomitant amiodarone, amlodipine, ranolazine or other products containing elbasvir or grazoprevir, the dose should not not exceed 10/20 mg/day. In patients on concomitant niacin (≥1 g/day), the dose should not exceed 10/20 mg/day. Adolescent ≥10 yr Dose range: 10/10 mg to 10/40 mg/day. Usual starting dose: 10/10 mg once daily in the evening. Patients w/ chronic kidney disease & eGFR <60 mL/min/1.73 m2 10/20 mg once daily in evening.
May be taken with or without food: Avoid grapefruit juice.
Hypersensitivity. Concomitant administration of lomitapide w/ doses >10/40 mg Vytorin in patients w/ HoFH. Active liver disease or unexplained persistent elevations in serum transaminases. Pregnancy & lactation. Simvastatin: Concomitant use w/ strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, HIV PIs, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, & drugs containing cobicistat), gemfibrozil, ciclosporin & danazol.
Special Precautions
Risk of myopathy & rhabdomyolysis. Measure creatine kinase level before starting treatment in: elderly ≥65 yr, female gender, renal impairment, uncontrolled hypothyroidism, personal or familial history of hereditary muscular disorders, previous history of muscular toxicity w/ statin or fibrate, alcohol abuse. Measure creatine kinase level if muscle pain, weakness or cramps occur. Perform liver function before treatment initiation & thereafter as clinically indicated. Discontinue in case of progressive & persistent elevation of transaminase levels (≥3x ULN); serious liver injury w/ clinical symptoms &/or hyperbilirubinaemia or jaundice. Patients who consume substantial quantities of alcohol. Co-administration w/ warfarin, other coumarin anticoagulants, fluindione. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Dizziness may affect ability to drive & use machines. Not recommended in patients w/ moderate or severe hepatic impairment. Not recommended for use in childn <10 yr. Ezetimibe: Co-administration w/ fibrates. Simvastatin: Patients w/ reduced function of hepatic OATP transport proteins. Risk of hyperglycaemia. Reports of interstitial lung disease. Concomitant use w/ daptomycin.
Adverse Reactions
Increased ALT &/or AST, increased blood CK; myalgia.
Drug Interactions
Small increase in mean AUC of niacin & nicotinuric acid. Ezetimibe: Decreased mean AUC w/ cholestyramine. Increased mean AUC w/ ciclosporin. Increased conc w/ fibrates (eg, fenofibrate or gemfibrozil). Increased INR w/ warfarin or fluindione. Simvastatin: Increased risk of myopathy &/or rhabdomyolysis w/ potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs [eg, nelfinavir], boceprevir, telaprevir, nefazodone, & medicinal products containing cobicistat); fluconazole; ciclosporin; danazol; gemfibrozil; amiodarone; ranolazine; Ca channel blockers (eg, verapamil, diltiazem, amlodipine); lomitapide; moderate CYP3A4 inhibitors; OATP1B1 inhibitors; BCRP inhibitors (eg, elbasvir, grazoprevir); colchicine; niacin (≥1 g/day); daptomycin. Co-administration of simvastatin w/ fusidic acid may increase plasma conc of both agents. Increased exposure w/ grapefruit juice. Decreased AUC w/ rifampicin (CYP3A4 inducer). Modestly potentiated effects of coumarin anticoagulants.
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.
Vytorin 10/10 mg tab
Vytorin 10/20 mg tab
Vytorin 10/40 mg tab
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