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| __NOTOC__
| | #REDIRECT [[Irbesartan#Nonclinical Toxicology]] |
| {{Irbesartan}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Nonclinical Toxicology==
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| ===Carcinogenesis, Mutagenesis, Impairment of Fertility===
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| No evidence of carcinogenicity was observed when irbesartan was administered at doses of up to 500/1000 mg/kg/day (males/females, respectively) in rats and 1000 mg/kg/day in mice for up to 2 years. For male and female rats, 500 mg/kg/day provided an average systemic exposure to irbesartan (AUC0–24 hour, bound plus unbound) about 3 and 11 times, respectively, the average systemic exposure in humans receiving the maximum recommended dose (MRD) of 300 mg irbesartan/day, whereas 1000 mg/kg/day (administered to females only) provided an average systemic exposure about 21 times that reported for humans at the MRD. For male and female mice, 1000 mg/kg/day provided an exposure to irbesartan about 3 and 5 times, respectively, the human exposure at 300 mg/day.
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| Irbesartan was not mutagenic in a battery of in vitro tests (Ames microbial test, rat hepatocyte DNA repair test, V79 mammalian-cell forward gene-mutation assay). Irbesartan was negative in several tests for induction of chromosomal aberrations (in vitro-human lymphocyte assay; in vivo-mouse micronucleus study).
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| Irbesartan had no adverse effects on fertility or mating of male or female rats at oral doses ≤650 mg/kg/day, the highest dose providing a systemic exposure to irbesartan (AUC0–24 hour, bound plus unbound) about 5 times that found in humans receiving the maximum recommended dose of 300 mg/day.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = AVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98 | publisher = | date = | accessdate = 20 February 2014 }}</ref>
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| ==References==
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| {{Reflist}}
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| {{Angiotensin II receptor antagonists}}
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| [[Category:Angiotensin II receptor antagonists]]
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| [[Category:Sanofi]]
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| [[Category:Bristol-Myers Squibb]]
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| [[Category:Tetrazoles]]
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| [[Category:Biphenyls]]
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| [[Category:Lactams]]
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| [[Category:Spiro compounds]]
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| [[Category:Nitrogen heterocycles]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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