|
|
| (One intermediate revision by one other user not shown) |
| Line 1: |
Line 1: |
| __NOTOC__
| | #REDIRECT [[Ticagrelor#Nonclinical Toxicology]] |
| {{Ticagrelor}}
| |
| {{CMG}}; {{AE}} {{JH}}
| |
| | |
| ==Nonclinical Toxicology==
| |
| | |
| ===Carcinogenesis, Mutagenesis, Impairment of Fertility===
| |
| | |
| <u>Carcinogenesis</u>
| |
| Ticagrelor was not [[carcinogenic]] in the mouse at doses up to 250 mg/kg/day or in the male rat at doses up to 120 mg/kg/day (19 and 15 times the MRHD of 90 mg twice daily on the basis of AUC, respectively). Uterine carcinomas, uterine adenocarcinomas and [[hepatocellular adenoma]]s were seen in female rats at doses of 180 mg/kg/day (29-fold the maximally recommended dose of 90 mg twice daily on the basis of AUC), whereas 60 mg/kg/day (8-fold the MRHD based on AUC) was not carcinogenic in female rats.
| |
| | |
| <u>Mutagenesis</u>
| |
| | |
| Ticagrelor did not demonstrate [[genotoxicity]] when tested in the Ames bacterial mutagenicity test, mouse lymphoma assay and the rat micronucleus test. The active O-demethylated metabolite did not demonstrate [[genotoxicity]] in the Ames assay and mouse lymphoma assay.
| |
| | |
| <u>Impairment of Fertility</u>
| |
| | |
| Ticagrelor had no effect on male [[fertility]] at doses up to 180 mg/kg/day or on female fertility at doses up to 200 mg/kg/day (>15-fold the MRHD on the basis of AUC). Doses of ≥10 mg/kg/day given to female rats caused an increased incidence of irregular duration estrus cycles (1.5-fold the MRHD based on AUC). <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8 | publisher = | date = | accessdate = 26 February 2014 }}</ref>
| |
| | |
| | |
| ==References==
| |
| | |
| <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8 | publisher = |date = | accessdate = 26 February 2014 }}</ref>
| |
| {{Reflist|2}}
| |
| | |
| {{Antithrombotics}}
| |
| | |
| [[Category:ADP receptor inhibitors]]
| |
| [[Category:Triazolopyrimidines]]
| |
| [[Category:Organofluorides]]
| |
| [[Category:Alcohols]]
| |
| [[Category:AstraZeneca]]
| |
| [[Category:Cardiovascular Drugs]]
| |
| [[Category:Drugs]]
| |