Information about ZETIA (ezetimibe)

The information on this site is intended for healthcare professionals in the United States and is not intended for the general public.

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Important Information About ZETIA

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bullet gif The effect of ZETIA on cardiovascular morbidity and mortality has not been determined.
bullet gif ZETIA, administered alone or in combination with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated TOTAL-C, LDL-C, and Apo B in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia when diet alone is not enough.
SELECTED CAUTIONARY INFORMATION
bullet gif ZETIA is not recommended in patients with moderate to severe hepatic impairment.
bullet gif The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is adequately studied.
bullet gif Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to both drugs is increased. Cyclosporine concentrations should be monitored in these patients.
bullet gif ZETIA should be used in pregnant or nursing women only if the benefit outweighs the risk.
bullet gif In clinical trials, regardless of causality assessment, the most frequent side effects for ZETIA coadministered with a statin vs statin alone included nasopharyngitis (3.7% vs 3.3%), myalgia (3.2% vs 2.7%), upper respiratory tract infection (2.9% vs 2.8%), arthralgia (2.6% vs 2.4%), and diarrhea (2.5% vs 2.2%); for ZETIA administered alone vs placebo: upper respiratory tract infection (4.3% vs 2.5%), diarrhea (4.1% vs 3.7%), arthralgia (3.0% vs 2.2%), sinusitis (2.8% vs 2.2%), pain in extremity (2.7% vs 2.5%), and fatigue (2.4% vs 1.5%).

Before prescribing ZETIA, please read the Prescribing Information.

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21050228(1)-06/10-ZET