Ezetrol Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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.

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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.

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Overdosage

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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. Pregnancy & lactation.

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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.

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Use In Pregnancy & Lactation

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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.

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Storage

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Description

View Ezetrol description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Dyslipidaemic Agents

ATC Classification

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

Regulatory Classification

Presentation/Packing

Form

Ezetrol tab 10 mg

Packing/Price

30's

Ezetrol

ezetimibe

Manufacturer:

Organon

Distributor:

Zuellig Pharma