simvastatin + ezetimibe


Merck Sharp & Dohme


Zuellig Pharma
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
Primary hypercholesterolemia: Adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), & non-high-density lipoprotein cholesterol (non-HDL-C), & to increase high-density lipoprotein cholesterol (HDL-C) in patients w/ primary (heterozygous familial & non-familial) hypercholesterolemia or mixed hyperlipidemia. Homozygous familial hypercholesterolemia (HoFH): Reduction of elevated total-C & LDL-C levels in patients w/ HoFH. Patients may also receive adjunctive treatments (eg, LDL apheresis).
Dosage/Direction for Use
Taken as single daily dose in the evening. Dose range: 10/10 mg daily through 10/80 mg daily. Usual starting dose: 10/20 mg daily. Initiation of therapy w/ 10/10 mg daily may be considered for patient requiring less aggressive LDL-C reductions. Patient who require larger reduction in LDL-C (>55%) may be started at 10/40 mg daily. HoFH 10/40 mg daily or 10/80 mg daily in the evening. Severe renal insufficiency (CrCl ≤30 mL/min) Dosage >10/10 mg daily should be implemented cautiously. 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 patient on concomitant cyclosporine, danazol or ≥1 g daily of niacin, the dose should not exceed 10/10 mg daily. In patient on concomitant amiodarone or verapamil, dose should not exceed 10/20 mg daily.
May be taken with or without food: Avoid excessive consumption (>1 L daily) of grapefruit juice.
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy & lactation.
Special Precautions
Increased risk of myopathy/rhabdomyolysis w/ concomitant use of potent inhibitors of CYP3A4 w/ higher doses of Vytorin: Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV PIs, or nefazodone; gemfibrozil & other fibrates or ≥1 g daily of niacin; cyclosporine or danazol; amiodarone or verapamil; diltiazem. Risk of myopathy & rhabdomyolysis is dose related to simvastatin. Consecutive transaminase elevations (>3 times upper limit of normal) has been observed. Perform baseline liver function tests & thereafter when clinically indicated. Substantial alcohol consumption &/or past history of liver disease. Not recommended in paed; moderate (Child-Pugh score 7-9) or severe (Child-Pugh score >9) liver dysfunction.
Adverse Reactions
Flatulence, myalgia, headache, abdominal pain, diarrhea, fatigue, thrombocytopenia, hepatitis. Rarely, rhabdomyolysis, increased CPK, elevations of liver transaminases, hypersensitivity reactions including rash & angioedema, pancreatitis, nausea, anemia, constipation, asthenia, jaundice, muscle cramps, myopathy, dizziness, paresthesia, peripheral neuropathy, alopecia, pruritus.
Drug Interactions
Potent inhibitors of CYP3A4: Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV PIs, nefazodone; gemfibrozil, other fibrates, niacin (nicotinic acid) (≥1 g daily), cyclosporine or danazol, amiodarone or verapamil, cholestyramine, diltiazem, fibrates, grapefruit juice, coumarin derivatives, antacids.
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 10/20 mg tab
Vytorin 10/10 mg tab
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