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| __NOTOC__
| | #REDIRECT [[Sotalol#Nonclinical Toxicology]] |
| {{Sotalol}}
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| {{CMG}}
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| ==Nonclinical Toxicology==
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| ====13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility====
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| No evidence of carcinogenic potential was observed in rats during a 24-month study at 137-275 mg/kg/ day (approximately 30 times the maximum recommended human oral dose (MRHD) as mg/kg or 5 times the MRHD as mg/m2) or in mice, during a 24-month study at 4141-7122 mg/kg/day (approximately 450-750 times the MRHD as mg/kg or 36-63 times the MRHD as mg/m2). Sotalol has not been evaluated in any specific assay of mutagenicity or clastogenicity.
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| No significant reduction in fertility occurred in rats at oral doses of 1000 mg/kg/day (approximately 100 times the MRHD as mg/kg or 9 times the MRHD as mg/m2) prior to mating, except for a small reduction in the number of offspring per litter.
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| Reproduction studies in rats and rabbits during organogenesis at 100 and 22 times the MRHD as mg/kg (9 and 7 times the MRHD as mg/m2), respectively, did not reveal any teratogenic potential associated with sotalol HCl. In rabbits, a high dose of sotalol HCl (160 mg/kg/day) at 16 times the MRHD as mg/kg (6 times the MRHD as mg/m2) produced a slight increase in fetal death likely due to maternal toxicity. Eight times the maximum dose (80 mg/kg/day or 3 times the MRHD as mg/m2) did not result in an increased incidence of fetal deaths. In rats, 1000 mg/kg/day sotalol HCl, 100 times the MRHD (18 times the MRHD as mg/m2), increased the number of early resorptions, while at 14 times the maximum dose (2.5 times the MRHD as mg/m2), no increase in early resorptions was noted. However, animal reproduction studies are not always predictive of human response.
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| ====13.2 Animal Toxicology and/or Pharmacology====
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| The LD50 of sotalol has been established in a variety of species. As the data in Table 5 show, LD50 is 100 to 1000 times more than the regular therapeutic dose:<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = SOTALOL HYDROCHLORIDE INJECTION [BIONICHE PHARMA USA LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2afe7385-2441-4e22-b63e-ab8614b275df | publisher = | date = | accessdate = }}</ref>
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| {|
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| | [[File:Sota23.png|800px|thumb]]
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Antiarrhythmic agents]]
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| [[Category:Beta blockers]]
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| [[Category:Drugs]]
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