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| __NOTOC__
| | #REDIRECT [[Bisoprolol#Nonclinical Toxicology]] |
| {{Bisoprolol }}
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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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| Long-term studies were conducted with oral bisoprolol fumarate administered in the feed of mice (20 and 24 months) and rats (26 months). No evidence of carcinogenic potential was seen in mice dosed up to 250 mg/kg/day or rats dosed up to 125 mg/kg/day. On a body weight basis, these doses are 625 and 312 times, respectively, the maximum recommended human dose (MRHD) of 20 mg, (or 0.4 mg/kg/day based on a 50 kg individual); on a body surface area basis, these doses are 59 times (mice) and 64 times (rats) the MRHD. The mutagenic potential of bisoprolol fumarate was evaluated in the microbial mutagenicity (Ames) test, the point mutation and chromosome aberration assays in Chinese hamster V79 cells, the unscheduled DNA synthesis test, the micronucleus test in mice, and the cytogenetics assay in rats. There was no evidence of mutagenic potential in these in vitro and in vivo assays.
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| Reproduction studies in rats did not show any impairment of fertility at doses up to 150 mg/kg/day of bisoprolol fumarate, or 375 and 77 times the MRHD on the basis of body weight and body surface area, respectively.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ZEBETA (BISOPROLOL FUMARATE) TABLET [DURAMED PHARMACEUTICALS, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a11548a0-9c0f-4729-907c-75d8f99a6c85 | publisher = | date = | accessdate = 4 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Beta blockers]] | | [[Category:Beta blockers]] |
| [[Category:Cardiovascular Drugs]] | | [[Category:Cardiovascular Drugs]] |
| [[Category:Drugs]] | | [[Category:Drugs]] |
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