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| __NOTOC__
| | #REDIRECT [[Hydralazine#Nonclinical Toxicology]] |
| {{Hydralazine}}
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| {{CMG}}; {{AE}} {{AK}}
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| ==Nonclinical Toxicology==
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| ===Carcinogenesis, Mutagenesis, Impairment of Fertility===
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| In a lifetime study in Swiss albino mice, there was a statistically significant increase in the incidence of lung tumors ([[adenomas ]]and [[adenocarcinomas]]) of both male and female mice given hydralazine continuously in their drinking water at a dosage of about 250 mg/kg per day (about 80 times the maximum recommended human dose). In a 2-year carcinogenicity study of rats given hydralazine by gavage at dose levels of 15, 30 and 60 mg/kg/day (approximately 5 to 20 times the recommended human daily dosage), microscopic examination of the liver revealed a small, but statistically significant increase in benign neoplastic nodules in male and female rats from the high-dose group and in female rats from the intermediate-dose group. Benign interstitial cell tumors of the testes were also significantly increased in male rats from the high-dose group. The tumors observed are common in aged rats and a significantly increased incidence was not observed until 18 months of treatment. Hydralazine was shown to be mutagenic in bacterial systems (Gene Mutation and DNA Repair) and in one of two rats and one rabbit hepatocyte in vitro DNA repair studies. Additional in vivo and in vitro studies using lymphoma cells, germinal cells and fibroblasts from mice, bone marrow cells from Chinese hamsters and fibroblasts from human cell lines did not demonstrate any mutagenic potential for hydralazine.
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| The extent to which these findings indicate a risk to man is uncertain. While long-term clinical observation has not suggested that human cancer is associated with hydralazine use, epidemiologic studies have so far been insufficient to arrive at any conclusions.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c3797028-c625-4f70-ae69-8a5f6f23f1b8 | publisher = | date = | accessdate = 10 March 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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