Ezetrol

Ezetrol

ezetimibe

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ezetimibe
Indications/Uses
Primary hypercholesterolaemia: Administered alone or w/ HMG-CoA reductase inhibitor (statin) indicated as adjunctive therapy to diet in patients w/ primary (heterozygous familial & non-familial) hypercholesterolaemia. Administered 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. Homozygous familial hypercholesterolaemia (HoFH): Administered w/ statin for patients w/ HoFH. Patients may also receive adjunctive treatments (eg, LDL apheresis). Homozygous sitosterolaemia (phytosterolaemia): Reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial sitosterolemia.
Dosage/Direction for Use
10 mg once daily, used alone or w/ statin. When co-administered w/ statin, consult dosage instructions for that particular statin. The stepwise increase of statin dose in combination treatment results in relatively small additional decrease of LDL-C, but increases risk of dose-related adverse events of the statin. This has to be considered for the risk-benefit-assessment when statin dose is considered. Co-administration w/ bile acid sequestrants: Dosing of Ezetrol should occur either ≥2 hr before or ≥4 hr after administration of bile acid sequestrants.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Combination w/ HMG-CoA reductase inhibitor in patients w/ active liver disease or unexplained persistent elevations in serum transaminases.
Special Precautions
When co-administered w/ statin, perform liver function tests at baseline & according to the recommendations of the statin. Not recommended for moderate (Child-Pugh scores 7-9) or severe (Child-Pugh score >9) liver dysfunction. Co-administration w/ fibrates not recommended. Caution when initiating Ezetrol in the setting of cyclosporine. Monitor cyclosporine conc. Pregnancy & lactation. Not recommended for childn <10 yr.
Adverse Reactions
Ezetrol alone: Headache, abdominal pain, diarrhea. Co-administered w/ statin: Headache, fatigue; abdominal pain, constipation, diarrhea, flatulence, nausea, increased ALT, increased AST, myalgia, elevations of CPK (≥10x ULN).
Drug Interactions
Antacids, cholestyramine, cyclosporine, fibrates.
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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