Acute, subacute and chronic toxicity studies of naltrexone have been conducted on a number of rodents and non-rodents. No unusual observations were made.
Carcinogenicity studies have been conducted on rats and mice. The results of these studies show that naltrexone is not carcinogenic under the applied conditions.
An extensive in-vitro and in-vivo trial yielded no relevant mutagenic potential.
Naltrexone (100 mg/kg, approximately 140 times the human therapeutic dose) caused a significant increase in pseudo-pregnancy in the rat. A decrease in the pregnancy rate of mated female rats also occurred. The relevance of these observations to human fertility is not known.
Naltrexone has been shown to have an embryocidal effect in the rat and rabbit when given in doses approximately 140 times the human therapeutic dose (see section 4.6). This effect was demonstrated in rats dosed with 100 mg/kg of naltrexone prior to and throughout gestation, and rabbits treated with 60 mg/kg of naltrexone during the period of organogenesis.
Acute, subacute and chronic toxicity studies of naltrexone have been conducted on a number of rodents and non-rodents. No unusual observations were made.
Carcinogenicity studies have been conducted on rats and mice. The results of these studies show that naltrexone is not carcinogenic under the applied conditions.
An extensive in-vitro and in-vivo trial yielded no relevant mutagenic potential.
Naltrexone has been shown to have an embryocidal effect in the rat and rabbit when given in doses approximately 140 times the human therapeutic dose (see section 4.6). This effect was demonstrated in rats dosed with 100 mg/kg of naltrexone prior to and throughout gestation, and rabbits treated with 60 mg/kg of naltrexone during the period of organogenesis.