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Pregnancy: Reproduction studies conducted in pregnant rats at doses up to 16 mg/kg (or about 25 times the human therapeutic dose) and in pregnant rabbits up to 40 mg/kg (or about 63 times the human therapeutic dose) did not show any evidence of a teratogenic potential. A non-significant increase in the incidence of minor skeletal abnormalities was noted at a dose of 16 mg/kg in rats.
No studies are available on the use of REMINYL in pregnant women. REMINYL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Breast-feeding: It is not known whether REMINYL is excreted in human breast milk and there are no studies in lactating women. Therefore, women on REMINYL should not breast-feed.
