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Pregnancy: There are no or limited amount of data from the use of dexmedetomidine in pregnant women. Studies in animals have shown reproductive toxicity. HYDEX is not recommended during pregnancy and in women of childbearing potential not using contraception.
Lactation: Available data in the rat have shown excretion of dexmedetomidine or metabolites in milk. A risk to infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue dexmedetomidine therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
