Isradipine nonclinical toxicology: Difference between revisions

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#REDIRECT [[Isradipine#Nonclinical Toxicology]]
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==Nonclinical Toxicology==
 
===Carcinogenesis, Mutagenesis, Impairment of Fertility===
 
Treatment of male rats for 2 years with 2.5, 12.5, or 62.5 mg/kg/day isradipine admixed with the diet (approximately 6, 31, and 156 times the maximum recommended daily dose based on a 50 kg man) resulted in dose dependent increases in the incidence of benign Leydig cell tumors and testicular [[hyperplasia]]relative to untreated control animals. These findings, which were replicated in a subsequent experiment, may have been indirectly related to an effect of isradipine on circulating gonadotropin levels in the rats; a comparable endocrine effect was not evident in male patients receiving therapeutic doses of the drug on a chronic basis. Treatment of mice for two years with 2.5, 15, or 80 mg/kg/day isradipine in the diet (approximately 6, 38, and 200 times the maximum recommended dose based on a 50 kg man) showed no evidence of oncogenicity. There was no evidence of mutagenic potential based on the results of a battery of mutagenic tests. No effect on fertility was observed in male and female rats treated with up to 60 mg/kg/day isradipine.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = ISRADIPINE CAPSULE [COBALT LABORATORIES] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=bf3425e0-428d-4bdb-ac9a-3b9d483df83a | publisher =  | date =  | accessdate = 28 February 2014 }}</ref>
 
==References ==
{{Reflist|2}}
 
[[Category:Calcium channel blockers]]
[[Category:Dihydropyridines]]
[[Category:Benzoxadiazoles]]
[[Category:Carboxylate esters]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]

Latest revision as of 02:02, 22 July 2014