Evaluation of the Developmental Toxicity of Amlodipine Besylate in Mice

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Amlodipine besylate, a dihydropyridine calcium antagonist, was evaluated for its potential to cause embryonal fetal toxicity and teratogenicity in pregnant mice. Amlodipine was administered in drinking fluid at dose levels of 0.2,0.8 and 1.6mg/kg body weight on days 1 through 21 of gestation. Litters were examined on gestational day 21. There were significant (p<0.05) decreases in the absolute and relative weights of the maternal heart, liver, pancreas and vagina in the 0.8 and 1.6mg/kg body weight amlodipine, and non-significant decreases in these measurements in the 0.2mg/kg body weight dose level. There was no fetal growth retardation as shown by the crown rump length in the 0.2 and 0.8mg/kg body weight amlodipine. At dose size of 1.6mg/kg body weight, amlodipine caused embryo lethality. The no-observed-adverse-effect level (NOAEL) was found to be 0.2mg/kg amlodipine.
公益社団法人日本薬学会の論文
2000-02-01