Zuellig Pharma
Concise Prescribing Info
Adjunctive therapy to diet w/ an HMG-CoA reductase inhibitor (statin) or alone for the reduction of elevated total-C, LDL-C, Apo B triglycerides, non-HDL-C to increase HDL-C in adult & adolescent (10-17 yr) patients w/ primary (heterozygous familial & non-familial) hypercholesterolemia. Adjunctive therapy to diet in combination w/ fenofibrate for the reduction of elevated total-C, LDL-C, Apo B & non-HDL-C in adult patients w/ mixed hyperlipidemia. Administered w/ statin, reduce risk of CV events (CV death, nonfatal MI & stroke, unstable angina hospitalization, or need for revascularization) in patients w/ CHD. Reduce risk of major CV events in patient w/ chronic kidney disease, administered w/ simvastatin. Reduction of elevated total-C & LDL-C levels in adult & adolescent (10-17 yr) patients w/ homozygous familial hypercholesterolemia (HoFH), administered w/ statin. Reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial sitosterolemia (phytosterolemia), administered w/ diet.
Dosage/Direction for Use
10 mg once daily, alone, w/ statin or w/ fenofibrate. CHD Combination therapy w/ statin 10 mg w/ proven CV benefit. Chronic kidney disease (GFR <60 mL/min/1.73 m2) 10 mg dose w/ 20 mg simvastatin once daily in the evening.
May be taken with or without food.
Special Precautions
Perform liver function tests prior to treatment w/ a statin & according to statin recommendations. Risk of myopathy or rhabdomyolysis. Discontinue treatment if myopathy is diagnosed or suspected. Moderate or severe hepatic insufficiency. Concomitant use w/ fibrates (other than fenofibrate) & cyclosporine. Consider alternative lipid-lowering therapy if cholelithiasis is suspected. Monitor INR if co-administered w/ warfarin, fluindione or other anticoagulants. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn.
Adverse Reactions
Abdominal pain, diarrhea, flatulence; fatigue. W/ statin: Increased ALT &/or AST, headache, myalgia. W/ fenofibrate: Abdominal pain.
Drug Interactions
Decreased AUC w/ cholestyramine. Increased AUC w/ cyclosporine. Cholesterol excretion into the bile may be increased, leading to cholelithiasis w/ fibrates. Increased INR w/ warfarin or fluindione.
ATC Classification
C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.
Ezetrol tab 10 mg
3 × 10's
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