9,10 Esketamine is the purified s-ketamine enantiomer and is only used intranasally. 8 Different formulations of ketamine are used intravenously as anesthetics for pain-relief and sedation. 4,6 The antidepressant effects long outlast the duration that the drug is in the body. It is a potent NMDA receptor antagonist, but also has antidepressant and pain modifying effects through unknown mechanisms. Ketamine is a 1:1 racemic mixture of r-ketamine and s-ketamine. To begin this evaluation, first we must understand the drug in the mother.Ĭharacteristics of Esketamine Estimates of Esketamine Transfer to Milk Without a clear answer from research, we have to turn to our understanding of pharmacokinetics to estimate an infant’s exposure to esketamine through breastmilk. There have been studies of the impact of ketamine use during cesarean sections, but milk supply in these studies had not yet been established, therefore milk transfer could not be evaluated. 2 However, a report by another manufacturer (Pfizer) states that injectable esketamine “is excreted into breast milk, but an effect on the child seems unlikely when using therapeutic doses.” 7 The research referenced in this document has not been published, and our requests for information thus far have been disregarded. 2 Other than detectable esketamine in the blood, no other details were listed regarding the effects of esketamine on this group of animal subjects. Animal studies conducted on the offspring of lactating animal-subjects stated that their young (not given esketamine) had detectable plasma concentrations of the drug when drinking milk from the mother taking intranasal esketamine. Because of the prolonged exposure, it is difficult to assess whether the results are correlated to exposure during gestational development, lactation, or both. The manufacturer (Janssen) conducted animal studies that showed sensorimotor delays in offspring born from animals given intranasal esketamine during gestation and lactation. There are no reports of adverse effects in breastfed infants, but we don’t know how many infants have previously been exposed to the drug through breastmilk. 6 However, this is a common response by pharmaceutical companies in response to a lack of available human data. Per the product manufacturer, women are advised not to breastfeed if using esketamine. Even without considering drug transfer into breastmilk, a mother’s capacity to care for her child will likely be impacted during this period of time.īreastfeeding and esketamine Limited observations and evidence After patients return home, they are asked to avoid activities that require complete alertness for a day after treatment. 2 For these reasons, patients are required to be monitored by medical personnel for at least two hours following each dose. In adults, intranasal esketamine can cause hypertension, dizziness, anxiety, lethargy, vertigo, sedation, dissociative reactions, nausea, and vomiting. 1,2,5 Specifics can be found on the Spravato website. Doses can be as high as 84 mg twice per week or as low as 56 mg every two weeks for maintenance therapy. 1,2,4 Doses and schedules vary by indication and phase of treatment. Intranasal esketamine (S-ketamine, SPRAVATO) is used as adjunct therapy for treatment-resistant depression and major depressive disorder with suicidality. Like its chemical parent ketamine, esketamine acts on NMDA receptors within the central nervous system. 3 More information about the pharmacokinetics of this drug may help a breastfeeding mother make an informed decision regarding lactation and concurrent use of intranasal esketamine. 2,3 Due to its chemical properties, esketamine likely penetrates breastmilk to a low degree. Nasal Esketamine (Spravato) and BreastfeedingĮsketamine can be part of the psychiatric management of treatment-resistant depression 1,2 and its compatibility with breastfeeding is currently unknown.
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