Ezetimibe
Efficacy
• Long-term effects on cardiovascular morbidity and mortality are unknown. • LDL-cholesterol lowered about 18%. • Additive LDL-cholesterol reduction when used in combination with statins.
• FDA approved Ezetimibe with fenofibrate.
Safety
• Short-term tolerability is similar to placebo. Long-term safety is unknown. • Not recommended for use in patients with moderate to severe hepatic impairment based on Child-Pugh score. The AUC of ezetimibe increased fourfold in patients with moderate hepatic impairment (Child-Pugh score 7 to 9). • Co-administration with cyclosporine increased ezetimibe blood level 12-fold in one renal transplant patient. Patients on cyclosporine and ezetimibe should be monitored carefully. • Cholestyramine co-administration decreased the mean AUC of total ezetimibe by 55%. Ezetimibe should be given two hours before or four hours after bile-acid sequestrants.
Dosing
• 10 mg daily without regard to meals or time of day.
• When combined with a statin, ezetimibe may be taken at the same time.
Exetimibe/Statin Combination Product
• Ezetimibe plus simvastatin. • Ezetimibe 10 mg/simvastatin 10 mg.
• Ezetimibe 10 mg/simvastatin 20 mg. • Ezetimibe 10 mg/simvastatin 40 mg. • Ezetimibe 10 mg/simvastatin 80 mg.
Efficacy
• Additive effects on LDL-cholesterol reduction.
Safety
• Please refer to information in the ezetimibe and statin sections of this appendix.
Dosing
• Please refer to dosing for simvastatin.
Please consult manufacturer's product labeling insert, or PDF for full prescribing information. (Dujovne, 2002 [C]; Gagne, 2002 [C]; McKenney, 2002 [R])
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