Ticlopidine nonclinical toxicology: Difference between revisions
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==Nonclinical Toxicology== | ==Nonclinical Toxicology== | ||
:*'''Carcinogenesis''':*'''Mutagenesis''':*'''Impairment of Fertility''' | :*'''Carcinogenesis''' | ||
:*'''Mutagenesis''' | |||
:*'''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. | 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> | 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== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Revision as of 16:56, 6 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Nonclinical Toxicology
- Carcinogenesis
- Mutagenesis
- 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.[1]
References
Adapted from the FDA Package Insert.