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| __NOTOC__
| | #REDIRECT [[Ezetimibe]] |
| {{Ezetimibe}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Warnings and Precautions==
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| ===Use with [[statin]]s or [[fenofibrate]]===
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| Concurrent administration of ZETIA with a specific [[statin]] or [[fenofibrate]] should be in accordance with the product labeling for that medication.
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| ===Liver Enzymes===
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| In controlled clinical monotherapy studies, the incidence of consecutive elevations (≥3 × the upper limit of normal [ULN]) in hepatic transaminase levels was similar between ZETIA (0.5%) and placebo (0.3%).
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| In controlled clinical combination studies of ZETIA initiated concurrently with a [[statin]], the incidence of consecutive elevations (≥3 × ULN) in hepatic transaminase levels was 1.3% for patients treated with ZETIA administered with [[statin]]s and 0.4% for patients treated with [[statin]]s alone. These elevations in transaminases were generally asymptomatic, not associated with cholestasis, and returned to baseline after discontinuation of therapy or with continued treatment. When ZETIA is coadministered with a [[statin]], liver tests should be performed at initiation of therapy and according to the recommendations of the [[statin]]. Should an increase in ALT or AST ≥3 × ULN persist, consider withdrawal of ZETIA and/or the [[statin]].
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| ===Myopathy/Rhabdomyolysis===
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| In clinical trials, there was no excess of myopathy or rhabdomyolysis associated with ZETIA compared with the relevant control arm (placebo or [[statin]] alone). However, myopathy and rhabdomyolysis are known adverse reactions to [[statin]]s and other lipid-lowering drugs. In clinical trials, the incidence of creatine phosphokinase (CPK) >10 × ULN was 0.2% for ZETIA vs. 0.1% for placebo, and 0.1% for ZETIA coadministered with a [[statin]] vs. 0.4% for [[statin]]s alone. Risk for skeletal muscle toxicity increases with higher doses of [[statin]], advanced age (>65), hypothyroidism, renal impairment, and depending on the [[statin]] used, concomitant use of other drugs.
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| In post-marketing experience with ZETIA, cases of [[myopathy]] and [[rhabdomyolysis]] have been reported. Most patients who developed [[rhabdomyolysis]] were taking a [[statin]] prior to initiating ZETIA. However, [[rhabdomyolysis]] has been reported with ZETIA monotherapy and with the addition of ZETIA to agents known to be associated with increased risk of [[rhabdomyolysis]], such as fibrates. ZETIA and any [[statin]] or fibrate that the patient is taking concomitantly should be immediately discontinued if [[myopathy]] is diagnosed or suspected. The presence of muscle symptoms and a CPK level >10 × the ULN indicates myopathy.
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| ===Hepatic Impairment===
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| Due to the unknown effects of the increased exposure to ezetimibe in patients with moderate to severe hepatic impairment, ZETIA is not recommended in these patients.[See Clinical Pharmacology (12.3).]<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a773b0b2-d31c-4ff4-b9e8-1eb2d3a4d62a | publisher = | date = | accessdate = 11 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Hypolipidemic agents]]
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| [[Category:Lactams]]
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| [[Category:Merck]]
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| [[Category:Schering-Plough]]
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| [[Category:Azetidines]]
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| [[Category:Organofluorides]]
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| [[Category:Phenols]]
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| [[Category:Cardiovasuclar Drugs]]
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| [[Category:Drugs]]
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