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Incidence of Reported Adverse Events During the 8-WeekDouble-Blind Period of the Comparative Trial With Bromocriptine.
In 72 healthy volunteerssingle or multiple dosesup to 2 mgof cabergoline resulted in selective inhibition of prolactin with no apparent effect on other anterior pituitary hormonesGHFSHLHACTHand TSHor cortisol.
In animalsbased on total radioactivitycabergolineand/or its metaboliteshas shown extensive tissue distributionRadioactivity in the . pituitary exceeded that in plasma by100-fold and was eliminated with a half-life of approximately 60 hoursThis finding is consistent with the long-lasting prolactin-lowering effect of the drugWhole body autoradiography studies in pregnant rats showed no fetal uptake but high levels in the uterine wallSignificant radioactivityparent plus metabolitesdetected in the milk of lactating rats suggests a potential for exposure to nursing infantsThe drug is extensively distributed throughout the bodyCabergoline is moderately bound40to 42to human plasma proteins in a concentration-independent mannerConcomitant dosing of highly protein-bound drugs is unlikely to affect its disposition.
There arehoweverno adequate and well-controlled studies in pregnant womenBecause animal reproduction studies are not always predictive of human responsethis drug should be used during pregnancy only if clearly needed.
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