Clopidogrel nonclinical toxicology: Difference between revisions

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#REDIRECT [[Clopidogrel#Nonclinical Toxicology]]
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==Nonclinical Toxicology==
 
====13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility====
 
There was no evidence of tumorigenicity when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats at dosages up to 77 mg/kg per day, which afforded plasma exposures >25 times that in humans at the recommended daily dose of 75 mg.
 
Clopidogrel was not genotoxic in four in vitro tests (Ames test, DNA-repair test in rat hepatocytes, gene mutation assay in Chinese hamster fibroblasts, and metaphase chromosome analysis of human lymphocytes) and in one in vivo test (micronucleus test by oral route in mice).
 
Clopidogrel was found to have no effect on fertility of male and female rats at oral doses up to 400 mg/kg per day (52 times the recommended human dose on a mg/m2 basis).<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB/SANOFI PHARMACEUTICALS PARTNERSHIP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=01b14603-8f29-4fa3-8d7e-9d523f802e0b | publisher =  | date =  | accessdate = }}</ref>
 
==References==
{{Reflist}}
 
{{FDA}}
 
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]

Latest revision as of 02:22, 22 July 2014