The Basics

What is Dexmedetomidine?

An anxiety reducing, sedative, and pain medication.

Brand names for Dexmedetomidine

Precedex

How Dexmedetomidine is classified

Hypnotics and Sedatives, Anesthetics – Intravenous, Adrenergic alpha-2 Receptor Agonists, Analgesics

Dexmedetomidine During Pregnancy

Dexmedetomidine pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Dexmedetomidine while pregnant

There are no adequate and well-controlled studies of Precedex use in pregnant women. In an in vitro 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, and Precedex should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 5 to 16) with doses up to 200 mcg/kg (representing a dose 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 (from gestation day 6 to 18) with doses up to 96 mcg/kg (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 of 200 mcg/kg. The no-effect dose in rats was 20 mcg/kg (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 at 8 and 32 mcg/kg (representing a dose less than the maximum recommended human intravenous dose based on a body surface area comparison) from gestation day 16 through weaning, lower offspring weights were observed. Additionally, when offspring of the 32 mcg/kg group were allowed to mate, elevated fetal and embryocidal toxicity and delayed motor development was observed in second generation offspring.

Taking Dexmedetomidine While Breastfeeding

What are recommendations for lactation if you're taking Dexmedetomidine?

Limited data indicate that very small amounts of dexmedetomidine are excreted into breastmilk for 6 hours after the end of an infusion. Because of the small amounts of colostrum secreted in the first day postpartum, the dose received by a neonate is unlikely to be of any consequence when the drug is used during delivery. The drug is absent from breastmilk by 24 hours after the end of an infusion. Dexmedetomidine would not be expected to cause adverse effects in breastfed infants or neonates.

Maternal / infant drug levels

Limited data indicate that very small amounts of dexmedetomidine are excreted into breastmilk for 6 hours after the end of an infusion. Because of the small amounts of colostrum secreted in the first day postpartum, the dose received by a neonate is unlikely to be of any consequence when the drug is used during delivery. The drug is absent from breastmilk by 24 hours after the end of an infusion. Dexmedetomidine would not be expected to cause adverse effects in breastfed infants or neonates.

Possible effects of Dexmedetomidine on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Dexmedetomidine

(Intravenous Sedation) Etomidate, Methohexital, Midazolam, Propofol.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Nakanishi R, Yoshimura M, Suno M et al. Detection of dexmedetomidine in human breast milk using liquid chromatography-tandem mass spectrometry: Application to a study of drug safety in breastfeeding after Cesarean section. J Chromatogr B Analyt Technol Biomed Life Sci. 2017;1040:208-13 PMID: 27856195
2. Yoshimura M , Kunisawa T, Suno M et al. Intravenous dexmedetomidine for cesarean delivery and its concentration in colostrum. Int J Obstet Anesth. 2017;32:28-32. PMID: 28687146

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

Read This Next

Methohexital

Methohexital and pregnancy or breastfeeding: Is it safe?

Read More

As seen in

Join our mailing list

Sign up for access to exclusive promotions, latest news and opportunites to test new pre-release products