Ezomib

Ezomib

ezetimibe

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ezetimibe
Indications/Uses
Monotherapy as adjunctive therapy to diet for use in patients w/ primary (heterozygous familial & non-familial) hypercholesterolaemia in whom a statin is considered inappropriate or not tolerated. In coadministration w/ statin as adjunctive therapy to diet in patients w/ primary (heterozygous familial & non-familial) hypercholesterolaemia who are inappropriately controlled w/ a statin alone; homozygous familial hypercholesterolaemia (HoFH); to reduce the risk of CV events (CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or for revascularization) in patients w/ CHD. Adjunctive therapy to diet in patients w/ homozygous familial sitosterolaemia. Reduce the risk of major CV events in patients w/ CKD.
Dosage/Direction for Use
Recommended dose: 10 mg daily. In combination w/ statin: CHD 10 mg w/ proven CV benefits. Renal impairment Patients w/ CKD w/ estimated GFR <60 mL/min/1.73 m2 10 mg ezomib + 20 mg simvastatin once daily in the evening. Co-administration w/ bile acid sequestrants Dosing should occur ≥2 hr prior to, or ≥4 hr after administration of bile sequestrants.
Administration
May be taken with or without food: Take either at least 2 hr before or 4 hr after administration of a bile acid sequestrant.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations in serum transaminases. Co-administration w/ statin. Pregnancy & lactation.
Special Precautions
Discontinue use if myopathy is suspected based on muscle symptoms or confirmed by creatine phosphokinase level >10x ULN; cholelithiasis & gall bladder diseases is suspected in a patient receiving treatment concomitantly w/ fenofibrate. Increased risk of rhabdomyolysis. Consecutive transaminase elevations (≥3x ULN). Perform LFTs at initiation of therapy. Monitor ciclosporin conc, & INR in patient receiving treatment concomitantly w/ ciclosporin, & warfarin, another coumarin anticoagulant, or fluindione, respectively. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not recommended in patients w/ moderate or severe hepatic impairment. Pregnancy. Not to be used during lactation. Childn <6 yr.
Adverse Reactions
Monotherapy: Abdominal pain, diarrhoea, flatulence; fatigue. In combination w/ statin: Headache; myalgia; increased ALT &/or AST. In combination w/ fenofibrate: Abdominal pain. W/ or w/o statin: Erythema multiforme.
Drug Interactions
Decreased absorption rate w/ antacid. Decreased mean AUC w/ cholestyramine. Increased total conc w/ gemfibrozil. Increased mean AUC w/ ciclosporin. Increased INR w/ warfarin or fluindione. Fibrates.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.
Presentation/Packing
Form
Ezomib tab 10 mg
Packing/Price
3 × 10's
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