EZB

EZB

ezetimibe

Manufacturer:

Millimed

Distributor:

Prosp Pharma

Marketer:

Prosp Pharma
Concise Prescribing Info
Contents
Ezetimibe
Indications/Uses
Alone or in combination w/ HMG-CoA reductase inhibitors (statins) as adjunctive therapy to diet in patients w/ primary (heterozygous familial & non-familial) hypercholesterolaemia. In combination w/ fenofibrate as adjunctive therapy to diet for reduction of elevated total-C, LDL-C, Apo B & non-HDL-C in patients w/ mixed hyperlipidemia. In combination w/ statin to reduce risk of major CV events (CV death, non-fatal MI & stroke, hospitalization for unstable angina or need for revascularization) in patients w/ chronic kidney disease, CHD & history of acute coronary syndrome; homozygous familial hypercholesterolaemia. Reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial sitosterolemia.
Dosage/Direction for Use
Recommended dose: 10 mg once daily alone or in combination w/ statin or fenofibrate. Combination w/ bile acid sequestrants Administer either at least 2 hr prior or 4 hr after. CHD & acute coronary syndrome event history 10 mg w/ statin. Chronic kidney disease (estimated GFR <60 mL/min/1.73 m2) 10 mg ezetimibe w/ 20 mg simvastatin once daily in the evening.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Consecutive transaminase elevation (≥3x ULN). Increased risk of myopathy or rhabdomyolysis in concomitant use w/ statin or fibrate. Discontinue if symptoms of myopathy or rhabdomyolysis; creatinine phosphokinase >10x ULN occur. Suspected cholelithiasis. Perform liver function tests at initiation of therapy. Monitor cyclosporine conc; INR. Not recommended in co-administration w/ fibrates (other than fenofibrate). Concomitant use w/ cyclosporine; warfarin, another coumarin anticoagulant, or fluindione. Not recommended in moderate or severe hepatic impairment (Child-Pugh class B or C). Pregnancy. Not to be used during lactation. Not recommended in childn <6 yr.
Adverse Reactions
Monotherapy: Diarrhea, flatulence. Co-administration w/ statin: Increased ALT &/or AST; headache; myalgia. Monotherapy & co-administration w/ fenofibrate: Abdominal pain.
Drug Interactions
Decreased mean AUC w/ cholestyramine. Increased serum conc w/ cyclosporine. Increased cholesterol excretion into the bile w/ fibrates. Increased total conc w/ fenofibrate; gemfibrozil. Increased INR w/ warfarin or fluindione.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.
Presentation/Packing
Form
EZB tab 10 mg
Packing/Price
3 × 10's
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