Concise Prescribing Info
Alone or in combination w/ HMG-CoA reductase inhibitor (statin), as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo B) & non-HDL-cholesterol in patients w/ primary (heterozygous familial & non-familial) hyperlipidemia. In combination w/ fenofibrate, as adjunctive therapy to diet for the reduction of total-C, LDL-C, Apo B, & non-HDL-C in adult patients w/ mixed hyperlipidemia. In combination w/ atorvastatin or simvastatin, for the reduction of elevated total-C & LDL-C levels in patients w/ homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatment are unavailable. Adjunctive therapy to diet for the reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial sisterolemia. In combination w/ simvastatin, to reduce the risk of major CV events in patients w/ chronic kidney disease. In combination w/ statins, to reduce the risk of CV events (CV death, non-fatal MI & stroke, hospitalization for unstable angina or need for revascularization) in patients w/ CHD; prevention of CV disease.
Dosage/Direction for Use
10 mg once daily. Concomitant lipid-lowering therapy May be administered w/ a statin (primary hyperlipidemia) or fenofibrate (mixed hyperlipidemia); ezetimibe daily dose may be taken at the same time as statin or fenofibrate. Co-administration w/ bile acid sequestrants Dosing should occur either ≥2 hr before or ≥4 hr after administration of bile acid sequestrant.
May be taken with or without food.
Hypersensitivity. Patients w/ active liver disease or unexplained persistent elevations in hepatic transaminase levels. Pregnancy & lactation.
Special Precautions
Moderate to severe hepatic impairment. W/draw (&/or the statin) if increase in ALT or AST ≥3 x ULN persists. Increased risk of skeletal muscle toxicity w/ higher doses of statin, advanced age (>65 yr), hypothyroidism, renal impairment & concomitant use of other drugs. Discontinue if myopathy is diagnosed or suspected. Concomitant use w/ fibrates. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Ped patients 10-17 yr; <10 yr or pre-menarchal girls. Elderly.
Adverse Reactions
Liver enzyme abnormalities; rhabdomyolysis & myopathy; arthralgia, dizziness, increased γ-glutamyltransferase; upper resp tract infection, diarrhea, arthralgia, sinusitis, pain in extremity; increased ALT & AST, myalgia, fatigue, headache; nasopharyngitis.
Drug Interactions
Increased exposure w/ cyclosporine. Cholesterol excretion into the bile may be increased w/ fibrates. Decreased mean AUC w/ cholestyramine. Increased INR w/ warfarin & fluindione. Fenofibrate.
ATC Classification
C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.
Ezentia tab 10 mg
3 × 10's
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