Ticlopidine nonclinical toxicology: Difference between revisions

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__NOTOC__
#REDIRECT [[Ticlopidine#Nonclinical Toxicology]]
{{Ticlopidine}}
{{CMG}}; {{AE}} {{AZ}}


==Nonclinical Toxicology==
[[Category: Cardiovascular Drugs]]
:*'''Carcinogenesis'''
[[Category: Drug]]
:*'''Mutagenesis'''
[[Category:Antiplatelet drugs]]
:*'''Impairment of Fertility'''
 
In a 2-year oral carcinogenicity study in rats, ticlopidine at daily doses of up to 100 mg/kg (610 mg/m2 ) was not tumorigenic. For a 70-kg person (1.73 m2 body surface area) the dose represents 14 times the recommended clinical dose on a mg/kg basis and two times the clinical dose on body surface area basis. In a 78-week oral carcinogenicity study in mice, ticlopidine at daily doses up to 275 mg/kg (1180 mg/m2 ) was not tumorigenic. The dose represents 40 times the recommended clinical dose on a mg/kg basis and four times the clinical dose on body surface area basis.
 
Ticlopidine was not mutagenic in vitro in the Ames test, the rat hepatocyte DNA-repair assay, or the Chinese-hamster fibroblast chromosomal aberration test; or in vivo in the mouse spermatozoid morphology test, the Chinese-hamster micronucleus test, or the Chinese-hamster bone-marrow-cell sister-chromatid exchange test. Ticlopidine was found to have no effect on fertility of male and female rats at oral doses up to 400 mg/kg/day.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = TICLOPIDINE HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=707127cb-cdcd-81b0-274d-3c11fefa6824 | publisher =  | date =  | accessdate = }}</ref>
 
==References==
{{Reflist}}
 
{{FDA}}
 
[[Category:Drugs]]

Latest revision as of 17:16, 20 August 2015