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| __NOTOC__
| | #REDIRECT [[Ezetimibe]] |
| {{Ezetimibe}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Use In Specific Populations==
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| ===Pregnancy===
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| '''Pregnancy Category C'''
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| There are no adequate and well-controlled studies of ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
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| In oral (gavage) embryo-fetal development studies of ezetimibe conducted in rats and rabbits during organogenesis, there was no evidence of embryolethal effects at the doses tested (250, 500, 1000 mg/kg/day). In rats, increased incidences of common fetal skeletal findings (extra pair of thoracic ribs, unossified cervical vertebral centra, shortened ribs) were observed at 1000 mg/kg/day (~10 × the human exposure at 10 mg daily based on AUC0–24hr for total ezetimibe). In rabbits treated with ezetimibe, an increased incidence of extra thoracic ribs was observed at 1000 mg/kg/day (150 × the human exposure at 10 mg daily based on AUC0–24hr for total ezetimibe). Ezetimibe crossed the placenta when pregnant rats and rabbits were given multiple oral doses.
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| Multiple-dose studies of ezetimibe given in combination with [[statins]] in rats and rabbits during organogenesis result in higher ezetimibe and statin exposures. Reproductive findings occur at lower doses in combination therapy compared to monotherapy.
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| All [[statins]] are contraindicated in pregnant and nursing women. When ZETIA is administered with a statin in a woman of childbearing potential, refer to the pregnancy category and product labeling for the statin. [See Contraindications (4).]
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| ===Nursing Mothers===
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| It is not known whether ezetimibe is excreted into human breast milk. In rat studies, exposure to total ezetimibe in nursing pups was up to half of that observed in maternal plasma. Because many drugs are excreted in human milk, caution should be exercised when ZETIA is administered to a nursing woman. ZETIA should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant.
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| ===Pediatric Use===
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| The effects of ZETIA coadministered with [[simvastatin]] (n=126) compared to [[simvastatin]] monotherapy (n=122) have been evaluated in adolescent boys and girls with [[heterozygous familial hypercholesterolemia]] (HeFH). In a multicenter, double-blind, controlled study followed by an open-label phase, 142 boys and 106 postmenarchal girls, 10 to 17 years of age (mean age 14.2 years, 43% females, 82% Caucasians, 4% Asian, 2% Blacks, 13% multi-racial) with HeFH were randomized to receive either ZETIA coadministered with [[simvastatin]] or [[simvastatin]] monotherapy. Inclusion in the study required 1) a baseline LDL-C level between 160 and 400 mg/dL and 2) a medical history and clinical presentation consistent with HeFH. The mean baseline LDL-C value was 225 mg/dL (range: 161–351 mg/dL) in the ZETIA coadministered with [[simvastatin]] group compared to 219 mg/dL (range: 149–336 mg/dL) in the [[simvastatin]] monotherapy group. The patients received coadministered ZETIA and [[simvastatin]] (10 mg, 20 mg, or 40 mg) or [[simvastatin]] monotherapy (10 mg, 20 mg, or 40 mg) for 6 weeks, coadministered ZETIA and 40-mg [[simvastatin]] or 40-mg [[simvastatin]] monotherapy for the next 27 weeks, and open-label coadministered ZETIA and [[simvastatin]] (10 mg, 20 mg, or 40 mg) for 20 weeks thereafter.
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| The results of the study at Week 6 are summarized in Table 3. Results at Week 33 were consistent with those at Week 6.</div>
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| <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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