Ezetrol

Ezetimibe

Alone or in combination w/ HMG-CoA reductase inhibitor (statin) as adjunctive therapy to diet for reduction of elevated total cholesterol (total-C), LDL-C, Apo B, triglycerides & non-HDL-C & to increase HDL-C in adult & adolescent patients 10-17 yr w/ primary (heterozygous familial & non-familial) hypercholesterolemia. In combination w/ fenofibrate as adjunctive therapy to diet for reduction of elevated total-C, LDL-C, Apo B & non-HDL-C in adult patients w/ mixed hyperlipidemia. Administered w/ statin to reduce risk of CV events (CV death, non-fatal MI & stroke, unstable angina hospitalization, or need for revascularization) in patients w/ CHD. Administered w/ simvastatin to reduce risk of major CV events in patients w/ CKD. Administered w/ statin for reduction of elevated total-C & LDL-C levels in adult & adolescent patients 10-17 yr w/ HoFH. Adjunct to diet for reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial sitosterolemia.

Primary Hypercholesterolemia Alone, w/ statin or w/ fenofibrate: 10 mg once daily. CHD Combination therapy w/ statin w/ proven CV benefit: 10 mg. Co-administration w/ bile acid sequestrants Administer either ≥2 hr before or 4 hr after bile acid sequestrant. CKD w/ estimated GFR <60 mL/min/1.73 m²) 10 mg + 20 mg simvastatin once daily in the evening.

May be taken with or without food.

Hypersensitivity.

Discontinue use if myopathy is diagnosed or suspected. Myopathy & rhabdomyolysis. Perform LFTs when co-administered w/ statin at initiation of therapy & according to recommendations of the statin. Consider gallbladder studies & alternative lipid-lowering therapy if cholelithiasis is suspected in patient receiving concomitant fenofibrate. Monitor INR if added to warfarin, another coumarin anticoagulant, or fluindione. Not recommended to use concomitantly w/ fibrates (other than fenofibrate). Concomitant use w/ cyclosporine; monitor cyclosporine conc. May affect ability to drive & use machines. Not recommended in patients w/ moderate (Child-Pugh score 7-9) or severe (Child-Pugh score >9) liver dysfunction. Pregnancy & lactation. Not recommended for children <6 yr.

Monotherapy: Diarrhea, flatulence; fatigue. Co-administration w/ statin: Increased ALT &/or AST; headache; myalgia. Monotherapy & co-administration w/ fenofibrate: Abdominal pain. SJS, TEN, DRESS.

Decreased mean AUC w/ cholestyramine. Increased mean AUC w/ cyclosporine. May increase cholesterol excretion into the bile, leading to cholelithiasis w/ fibrates. Increased INR w/ warfarin or fluindione.

Dyslipidaemic Agents

C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.

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