Zuellig Pharma
Concise Prescribing Info
Alone or in combination w/ an HMG-CoA reductase inhibitor (statin) as an adjunct to diet for the reduction of elevated total-C, LDL-C & Apo B in patients w/ primary hypercholesterolemia. In combination w/ fenofibrate as an adjunct to diet for the reduction of elevated total-C, LDL-C, Apo B & non-HDL-C in patients w/ mixed hyperlipidemia. In combination w/ atorvastatin or simvastatin for the reduction of elevated total-C & LDL-C in patients w/ homozygous familial hypercholesterolemia. Adjunctive therapy to diet for the reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial sitosterolemia.
Dosage/Direction for Use
10 mg once daily. In concomitant use w/ bile acid sequestrants, administer ≥2 hr before or ≥4 hr after the administration of the bile acid sequestrant.
May be taken with or without food.
Hypersensitivity. In combination w/ a statin in patients w/ active liver disease or unexplained persistent elevations in serum transaminases. Co-administration w/ statins & fenofibrate during pregnancy & lactation.
Special Precautions
When co-administered w/ a statin, perform liver function tests at initiation of therapy & according to the recommendations of the statin. Discontinue use if myopathy is diagnosed or suspected. Increased risk of rhabdomyolysis. Moderate or severe hepatic insufficiency. Concomitant use w/ fibrates (other than fenofibrate); cyclosporine; anticoagulants. Gallbladder studies are indicated & alternative lipid-lowering therapy should be considered when cholelithiasis is suspected in patients receiving Ezetrol & fenofibrate. INR should be appropriately monitored if Ezetrol is added to warfarin, another coumarin anticoagulant or fluindione. Pregnancy & lactation (monotherapy). Childn <10 yr.
Adverse Reactions
Upper resp tract infection, diarrhea, arthralgia, pain in the extremity. Monotherapy: Sinusitis, dizziness, increased γ-glutamyltransferase. Co-administration w/ statins: Nasopharyngitis, myalgia, increased alanine/aspartate aminotransferases, fatigue, headache.
Drug Interactions
Decreased mean AUC w/ cholestyramine. Increased AUC of cyclosporine. Fibrates (other than fenofibrate) increase cholesterol excretion into the bile, leading to cholelithiasis.
ATC Classification
C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.
Ezetrol tab 10 mg
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