Ezetrol

Ezetrol

ezetimibe

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ezetimibe
Indications/Uses
Primary hypercholesterolemia, homozygous familial hypercholesterolemia, homozygous sitosterolemia (phytosterolemia). Prevention of CV disease. Prevention of major CV events in chronic kidney disease.
Dosage/Direction for Use
Patient w/ primary hypercholesterolemia 10 mg once daily, alone or in combination w/ statin or fenofibrate. Renal impairment/chronic kidney disease Monotherapy: No dosage adjustment necessary. Combination therapy w/ simvastatin in patient w/ mild renal impairment (GFR approx >60 mL/min/1.73 m2) No dosage adjustment necessary. Patient w/ chronic kidney disease (GFR approx <60 mL/min/1.73 m2) Ezetrol 10 mg & simvastatin 20 mg once daily in the evening.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Perform liver function tests at initiation of therapy w/ a statin. Discontinue if myopathy or any unexplained muscle pain, tenderness or weakness develops during concomitant use w/ statin. Moderate or severe hepatic insufficiency. Co-administration w/ fibrates other than fenofibrate. Monitor cyclosporine conc. Consider alternative lipid-lowering therapy if cholelithiasis is suspected w/ concomitant use w/ fenofibrate. Monitor INR if administered w/ warfarin or fluindione. Pregnancy. Not to be used during lactation. Not recommended in childn <6 yr.
Adverse Reactions
Monotherapy: Abdominal pain, diarrhea, flatulence, fatigue. Combination therapy w/ statin: Increased ALT &/or AST, headache, myalgia. Combination therapy w/ fenofibrate: Abdominal pain.
Drug Interactions
Decreased absorption w/ antacids. Decreased mean AUC w/ cholestyramine; increased mean AUC w/ cyclosporine. Not recommended w/ fibrates (other than fenofibrate). Increased INR w/ warfarin & fluindione.
ATC Classification
C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.
Presentation/Packing
Form
Ezetrol tab 10 mg
Packing/Price
30's (P1,275/pack)
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