Mibeaz

Ezetimibe

Alone or in combination w/ HMG-CoA reductase inhibitors (statins) as adjunct 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 10-17 yr w/ primary (heterozygous familial & non-familial) hypercholesterolemia. In combination w/ fenofibrate as adjunct to diet for reduction of evaluated total-C, LDL-C, apo B & non-HDL-C in adults w/ mixed hyperlipidemia. In combination w/ statin for reduction of elevated total-C & LDL-C levels in adult & adolescent 10-17 yr w/ HoFH as adjunct to other lipid-lowering treatments eg, LDL apheresis. Adjunct to diet for reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial sitosterolemia. In combination w/ statin to reduce risk of CV events (CV death, non-fatal MI & stroke, hospitalization for unstable angina or need for revascularization) in patient w/ CHD. In combination w/ simvastatin to reduce risk of major CV events in patient w/ CKD.

Primary hypercholesterolemia, HoFH, homozygous sitosterolemia Adult & childn ≥10 yr 10 mg once daily. Fixed combination w/ simvastatin for management of HoFH Adult 10 mg ezetimibe & 40 mg simvastatin once daily in the evening. Prevention of CV disease 10 mg w/ statin. May be used alone or in combination w/ statin or fenofibrate & administered at the same time as statin or fenofibrate. In combination w/ bile acid sequestrants Administer at least 2 hr before or 4 hr after. CKD & estimated GFR <60 mL/min/1.73 m² 10 mg ezetimibe & 20 mg simvastatin once daily in the evening.

May be taken with or without food.

Hypersensitivity. Patients w/ active liver disease or unexplained, persistent increases in serum aminotransferase (transaminase) conc (when combined w/ HMG-CoA reductase inhibitors). Concomitant use of ezetimibe & simvastatin fixed combination w/ potent CYP450 3A4 inhibitors eg, cyclosporine, danazol or gemfibrozil.

Discontinue treatment immediately if myopathy is suspected or confirmed (symptomatic patient w/ creatinine phosphokinase >10x ULN). Consider discontinuation of ezetimibe &/or statin for persistently elevated transaminase (ALT or AST ≥3x ULN). Increased risk of myopathy w/ concomitant statin or fibrate; in patients >65 yr or w/ hypothyroidism; w/ higher dosage statin. Higher incidence of elevated transaminases (≥3x ULN) w/ concomitant use of statin. Severe (CrCl ≤30 mL/min/1.73 m²) & moderate to severe renal impairment CrCl <60 mL/min/1.73 m²). Mild hepatic impairment (Child-Pugh score 5-6, class A). Not recommended in moderate or severe hepatic impairment (Child-Pugh score 7-9, class B or >9, class C). Contraindicated in pregnant women required to take combination of ezetimibe w/ HMG-CoA reductase inhibitor. Not to be used in lactation. Ped patients <6 yr.

Fatigue; diarrhea; increased serum transaminases; flu; arthralgia, pain in extremity; sinusitis, URTI.

May enhance adverse/toxic effect w/ bezafibrate, fenofibrate & derivatives, gemfibrozil. May decrease absorption w/ bile acid sequestrants. May increase serum conc w/ systemic cyclosporine. Decreased AUC & peak plasma conc w/ Al- & Mg hydroxide-containing antacids. Decreased AUC & increased peak plasma conc w/ HMG-COA reductase inhibitors eg, atorvastatin, fluvastatin, lovastatin, pravastatin or rosuvastatin. Increased INR w/ warfarin.

Dyslipidaemic Agents

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

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