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Pregnant Women: There are no studies of pramipexole dihydrochloride monohydrate in pregnant women. Because animal reproduction studies are not always predictive of human response, APO-PRAMIPEXOLE should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
Nursing Women: The excretion of pramipexole into breast milk has not been studied in women. Since pramipexole dihydrochloride monohydrate suppresses lactation, it should not be administered to mothers who wish to breast-feed infants.
A single-dose, radio-labelled study showed that drug-related materials were excreted into the breast milk of lactating rats. Concentrations of radioactivity in milk were three to six times higher than concentrations in plasma at equivalent time points.
