Dexmedetomidine Pregnancy and Breastfeeding Warnings

Dexmedetomidine is also known as: Precedex

Dexmedetomidine Pregnancy Warnings

Teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine during the period of fetal organogenesis (gestation day 5 to 16) with doses approximately equal to the maximum recommended human intravenous dose based on body surface area or in rabbits following intravenous administration of dexmedetomidine during the period of fetal organogenesis (gestation day 6 to 18) with doses representing approximately half the human exposure at the maximum recommended dose based on plasma area under the time curve comparison. However, fetal toxicity, as evidenced by increased post implantation losses and reduced live pups, was observed in rats at a subcutaneous dose representing a dose less than the maximum recommended human intravenous dose based on a body surface area comparison. In another reproductive toxicity study when dexmedetomidine was administered subcutaneously to pregnant rats from gestation day 16 through weaning, lower offspring weights were observed. Additionally, when offspring of the group were allowed to mate, elevated fetal and embryocidal toxicity and delayed motor development was observed in second generation offspring.

Dexmedetomidine has been assigned to pregnancy category C. There are no adequate and well controlled studies of dexmedetomidine use in pregnant women. In an invitro human placenta study, placental transfer of dexmedetomidine occurred. In a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. Thus, fetal exposure should be expected in humans. Dexmedetomidine is only recommended for use during pregnancy if the potential benefits justify the potential risk to the fetus.

Dexmedetomidine Breastfeeding Warnings

There are no data on the excretion of dexmedetomidine into human milk. Radiolabeled dexmedetomidine administered subcutaneously to lactating female rats was excreted in milk. Because many drugs are excreted into human milk, caution should be exercised when dexmedetomidine is administered to a nursing woman.

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