Clopidogrel nonclinical toxicology: Difference between revisions
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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. | |||
<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> | 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== | ==References== | ||
Revision as of 16:56, 6 March 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]
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).[1]
References
Adapted from the FDA Package Insert.