EZB

EZB Special Precautions

ezetimibe

Manufacturer:

Millimed

Distributor:

Prosp Pharma

Marketer:

Prosp Pharma
Full Prescribing Info
Special Precautions
Co-administration of ezetimibe with statins or fenofibrate, refer the package insert for the particular medication.
Liver enzyme: In controlled co-administration trials which receiving ezetimibe with a statin, consecutive transaminase elevation (≥3 X the upper limit normal [ULN]) have been observed. When ezetimibe is co-administered with statin, liver function tests should be performed at initiation of therapy and according to the recommendations of the statin.
Skeletal muscle: Myopathy and rhabdomyolysis have been rarely reported with ezetimibe; in clinical trials, there is no excess of myopathy or rhabdomyolysis associated with ezetimibe, risk may be increased with concomitant use of statin or fibrate. Should be immediately discontinued if these symptoms are present and creatinine phosphokinase (CPK) is > 10 times the upper limit of normal, ULN.
Hepatic impairment: Systemic exposure is increased in hepatic impairment. Use is not recommended in patients with moderate or severe hepatic impairment. Due to the unknown effects of the increased exposure of the ezetimibe in patients with moderate or severe hepatic insufficiency, ezetimibe is not recommended in these patients.
Fibrates: The co-administration of ezetimibe with fibrates other than fenofibrate has not been studied. Therefore, co-administration of ezetimibe and fibrates (other than fenofibrate) is not recommended.
Fenofibrate: If cholelithiasis is suspected in a patient receiving ezetimibe and fenofibrate, gallbladder studies and indicated and alternative lipid-lowering therapy should be considered.
Cyclosporine: Caution should be exercised when initiating ezetimibe in the setting of cyclosporine. Cyclosporine concentrations should be monitored in patients receiving ezetimibe and cyclosporine.
Anticoagulants: If ezetimibe is added to warfarin, another coumarin anticoagulant, or fluindione, the International Normalized Ratio (INR) should be appropriately monitored.
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