Concise Prescribing Info
Contents
Ezetimibe 10 mg, simvastatin 40 mg
Indications/Uses
Reduce risk of CV events (CV death, nonfatal MI & stroke, hospitalization for unstable angina or need for revascularization) in patients w/ CHD & history of acute coronary syndrome (ACS) either previously treated w/ statin or not. Adjunctive therapy to diet for reduction of elevated total cholesterol (total-C), LDL-C, apolipoprotein B (Apo B), triglycerides (TG) & non-HDL-C & to increase HDL-C in patients w/ primary (heterozygous familial & non-familial) hypercholesterolemia or mixed hyperlipidaemia. Reduction of elevated total-C & LDL-C levels in patients w/ homozygous familial hypercholesterolemia (HoFH).
Dosage/Direction for Use
Primary hypercholesterolemia or mixed hyperlipidemia Dose range: 10/10-10/80 mg daily as single dose. Recommended usual starting dose: 10/20 mg daily. Patient requiring less aggressive LDL-C reduction Initially 10/10 mg daily. Patient requiring larger LDL-C reduction Initially 10/40 mg daily. Patient at high risk for CV complications 10/80 mg daily. HoFH 10/40 or 10/80 mg daily in the evening. Concomitant use w/ lomitapide Not to exceed 10/40 mg daily. Patient taking fibrates Not to exceed 10/10 mg daily. Patient taking amiodarone, verapamil, diltiazem Not to exceed 10/20 mg daily. Patient taking amlodipine or niacin ≥1 g daily Not to exceed 10/40 mg daily.
Administration
May be taken with or without food: Take in the evening. Avoid grapefruit juice.
Contraindications
Hypersensitivity. Concomitant use w/ potent CYP3A4 inhibitors eg, itraconazole, ketoconazole, posaconazole, voriconazole, HIV PIs, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, cobicistat-containing drugs; gemfibrozil, cyclosporine, danazol. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy & lactation.
Special Precautions
Discontinue use if persistent rise in transaminases >3 x upper limit of normal, serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs. Myopathy, rhabdomyolysis; uncontrolled hypothyroidism. Temporarily discontinue use prior to elective major surgery, when major medical or surgical conditions supervenes. Perform liver function tests prior to & thereafter when clinically indicated. Not to be used concomitantly w/ potent CYP3A4 inhibitors, gemfibrozil, cyclosporine, danazol. Not recommended in concomitant use w/ fusidic acid. Avoid concomitant use w/ other fibrates. Concomitant use w/ amiodarone, Ca-channel blockers, lomitapide, CYP3A4 moderate inhibitors, niacin ≥1 g daily, anticoagulants. Female patients. May affect ability to drive & use machines. Patients consuming substantial amount of alcohol, history of hepatic disease. Not recommended in moderate or severe hepatic insufficiency. Severe renal insufficiency (CrCl <30 mL/min). Not to be used during pregnancy & lactation. Not recommended in paed patients. Elderly ≥65 yr.
Adverse Reactions
Increased ALT, AST, blood CK; myalgia.
Drug Interactions
Increased risk of myopathy w/ potent CYP3A4 inhibitors eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs (eg, nelfinavir), boceprevir, telaprevir, nefazodone, cobicistat-containing drugs; fenofibrate, other fibrates; Ca-channel blockers; fusidic acid; amiodarone; lomitapide; moderate CYP3A4 inhibitors; niacin ≥1 g daily; colchicine. Decreased mean AUC w/ cholestyramine. Increased plasma conc w/ OATP1B1 transporter & breast cancer resistant protein inhibitors; grapefruit juice. Monitor prothrombin time w/ coumarin anticoagulants. Not to be used w/ gemfibrozil, cyclosporine, danazol.
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
Vytocor tab
Packing/Price
1 × 10's;10 × 10's;3 × 10's
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