Ezetrol

Ezetrol

ezetimibe

Manufacturer:

Organon

Distributor:

Zuellig 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 CV events (CV death, nonfatal MI & stroke, hospitalization for unstable angina or need for revascularization) in patients w/ CHD & history of acute coronary syndrome; HoFH. Reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial sitosterolaemia.
Dosage/Direction for Use
Primary hypercholesterolemia & CHD 10 mg once daily. Co-administration w/ bile acid sequestrants Administer either ≥2 hr prior or 4 hr after.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Combination w/ statin in patients w/ active liver disease or unexplained persistent serum transaminases elevation; in women of childbearing potential; during pregnancy & lactation.
Special Precautions
Discontinue use if myopathy is diagnosed or suspected. Perform LFTs prior to initiation of therapy & according to statin recommendations. Not recommended w/ other fibrates. Concomitant use fenofibrate, cyclosporine, warfarin, another coumarin anticoagulant or fluindione. Not recommended in moderate or severe hepatic insufficiency. Pregnancy. Not to be used during lactation. Not recommended in childn <10 yr.
Adverse Reactions
Monotherapy: Diarrhea, flatulence; fatigue. Combination w/ statin: Increased ALT &/or AST; headache; myalgia. Monotherapy & combination w/ fenofibrate: Abdominal pain.
Drug Interactions
Decreased mean AUC w/ cholestyramine. Increased mean AUC w/ cyclosporine. Increased cholesterol excretion w/ other fibrates. 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
Ezetrol tab 10 mg
Packing/Price
30's
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