Ezetimibe Sandoz

Ezetimibe Sandoz





Zuellig Pharma
Concise Prescribing Info
As adjunctive therapy to diet for patients w/ primary (heterozygous familial & non-familial) hypercholesterolaemia in combination w/ statins, who are not appropriately controlled w/ statins alone, or as monotherapy in whom a statin is considered inappropriate or not tolerated. Adjunctive therapy to diet in patients w/ homozygous familial hypercholesterolaemia (HoFH). Adjunctive therapy to diet in patients w/ homozygous familial sitosterolaemia (phytosterolaemia). Reduction of risk of major CV events in patients w/ chronic kidney disease in combination w/ simvastatin. Reduction of risk of CV events (CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or need for revascularization) in patients w/ CHD in combination w/ a statin.
Dosage/Direction for Use
10 mg daily. Concomitant use w/ bile acid sequestrants Dosing should occur either ≥2 hr before or ≥4 hr after bile acid sequestrant administration.
May be taken with or without food.
Hypersensitivity. Concomitant use w/ statins: Active liver disease or unexplained persistent elevations in serum transaminases, pregnancy & lactation.
Special Precautions
Perform liver function test at initiation of therapy & according to recommendations of the statin. Risk of myopathy & rhabdomyolysis. Discontinue if creatine phosphokinase (CPK) level >10 x ULN & cholelithiasis occurs. Moderate or severe hepatic impairment. Concomitant use w/ fibrates, ciclosporin, & warfarin, another coumarin anticoagulant or fluindione. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Pregnancy & lactation. Ped patients <6 yr; w/ simvastatin dose >40 mg daily: 10-17 yr; w/ simvastatin: ≤10 yr; long-term efficacy of therapy: <17 yr.
Adverse Reactions
Abdominal pain, diarrhea, flatulence; fatigue; headache; myalgia; increased ALT &/or AST.
Drug Interactions
Decreased AUC w/ cholestyramine. Possible risk of cholelithiasis & gallbladder disease w/ fenofibrate. Concomitant use w/ ciclosporin. Increased INR w/ warfarin or fluindione.
ATC Classification
C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.
Ezetimibe Sandoz tab 10 mg
3 × 10's
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