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| __NOTOC__
| | #REDIRECT [[Cilostazol#Nonclinical Toxicology]] |
| {{Cilostazol}}
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| {{CMG}}; {{AE}} {{AZ}}
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| ==Nonclinical Toxicology==
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| ===Carcinogenesis, Mutagenesis, Impairment of Fertility===
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| Dietary administration of cilostazol to male and female rats and mice for up to 104 weeks, at doses up to 500 mg/kg/day in rats and 1000 mg/kg/day in mice, revealed no evidence of carcinogenic potential. The maximum doses administered in both rat and mouse studies were, on a systemic exposure basis, less than the human exposure at the MRHD of the drug. Cilostazol tested negative in bacterial gene mutation, bacterial [[DNA]] repair, mammalian cell gene mutation, and mouse in vivo bone marrow chromosomal aberration assays. It was, however, associated with a significant increase in chromosomal aberrations in the in vitro Chinese Hamster Ovary Cell assay.
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| Cilostazol did not affect [[fertility ]]or mating performance of male and female rats at doses as high as 1000 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound cilostazol were less than 1.5 times in males, and about 5 times in females, the exposure in humans at the MRHD.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = PLETAL (CILOSTAZOL) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24d75b58-bafb-4440-b8d7-4f4079c08b0b | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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