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A dose of 0.012 mg/kg/dayapproximately 1/7 the maximum recommended human doseduring the period of organogenesis in rats caused an increase in post-implantation embryofetal lossesThese losses could be due to the prolactin inhibitory properties of cabergoline in ratsAt daily doses of 0.5 mg/kg/dayapproximately 19 times the maximum recommended human doseduring the period of organogenesis in the rabbitcabergoline caused maternotoxicity characterized by a loss of body weight and decreased food consumptionDoses of 4 mg/kg/dayapproximately 150 times the maximum recommended human doseduring the period of organogenesis in the rabbit caused an increased occurrence of various malformationsHoweverin another study in rabbitsno treatment-related malformations or embryofetotoxicity were observed at doses up to 8 mg/kg/dayapproximately 300 times the maximum recommended human dose

There was a slight increase in the incidence of cervical and uterine leiomyomas and uterine leiomyosarcomas in miceIn ratsthere was a slight increase in malignant tumors of the cervix and uterus and interstitial cell adenomasThe occurrence of tumors in female rodents may be related to the prolonged suppression of prolactin secretion because prolactin is needed in rodents for the maintenance of the corpus luteumIn the absence of prolactinthe estrogen/progesterone ratio is increasedthereby increasing the risk for uterine tumorsIn male rodentsthe decrease in serum prolactin levels was associated with an increase in serum luteinizing hormonewhich is thought to be a compensatory effect to maintain testicular steroid synthesisSince these hormonal mechanisms are thought to be species-specificthe relevance of these tumors to humans is not known.

It is not known whether this drug is excreted in human milkBecause many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cabergolinea decision should be made whether to discontinue nursing or to discontinue the drugtaking into account the importance of the drug to the motherUse of DOSTINEX for the inhibition or suppression of physiologic lactation is not recommendedsee PRECAUTIONS section

Incidence of Reported Adverse Events During the 8-WeekDouble-Blind Period of the Comparative Trial With Bromocriptine.

Reproduction studies have been performed with cabergoline in miceratsand rabbits administered by gavageMultiples of the maximum recommended human dose in this section are calculated on a body surface area basis using total mg/mweek for animals and mg/mweek for a 50 kg human

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