Question

I am a breastfeeding mother and i want to know if it is safe to use ORG 9426? Is ORG 9426 safe for nursing mother and child? Does ORG 9426 extracts into breast milk? Does ORG 9426 has any long term or short term side effects on infants? Can ORG 9426 influence milk supply or can ORG 9426 decrease milk supply in lactating mothers?

ORG 9426 lactation summary

ORG 9426 is safe in breastfeeding
  • DrLact safety Score for ORG 9426 is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of ORG 9426 is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that ORG 9426 does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of ORG 9426 safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About ORG 9426 usage in lactation

It is a non-depolarizing muscle relaxant drug with a peripheral action that is used as premedication for endotracheal intubation, general anesthesia and mechanical ventilation. Breastfed infants have not shown any problem after 1.5 to 5 hours of anesthesia time period with Rocuronio (additional drugs like Propofol, Remifentanil and Xenon were used). A high molecular weight may decrease excretion into breast milk as well as a rapid elimination time. In addition, a low oral bioavailability makes unlikely a pass from ingested mother's milk onto the infant's plasma. ORG 9426 should not prevent a mother from breast feeding her baby shortly after recovering from an anesthesia if she is in good condition.

Answer by DrLact: About ORG 9426 usage in lactation

Limited information on the use of ORG 9426 during breastfeeding indicates that no adverse infant effects occur. Because it is short acting, highly polar and poorly absorbed orally, it is not likely to reach the breastmilk in high concentration or to reach the bloodstream of the infant.[1][2] When a combination of anesthetic agents is used for a procedure, follow the recommendations for the most problematic medication used during the procedure. General anesthesia for cesarean section using ORG 9426 as a component may delay the onset of lactation.

ORG 9426 Side Effects in Breastfeeding

Four mothers who underwent general anesthesia were given propofol and remifentanil as induction agents and ORG 9426 for intubation. After induction, propofol was stopped and xenon inhalation was used to maintain anesthesia for between 57 and 70 minutes. Infants resumed breastfeeding from 1.5 to 5 hours after the end of surgery. None of the infants had noticeable symptoms of dizziness or drowsiness. All infants fared well at home after their mothers were discharged.[3]

ORG 9426 Possible Effects in Breastfeeding

A randomized study compared the effects of cesarean section using general anesthesia, spinal anesthesia, or epidural anesthesia, to normal vaginal delivery on serum prolactin and oxytocin as well as time to initiation of lactation. General anesthesia was performed using propofol 2 mg/kg and ORG 9426 0.6 mg/kg for induction, followed by sevoflurane and ORG 9426 0.15 mg/kg as needed. After delivery, patients in all groups received an infusion of oxytocin 30 international units in 1 L of saline, and 0.2 mg of methylergonovine if they were not hypertensive. Fentanyl 1 to 1.5 mcg/kg was administered after delivery to the general anesthesia group. Patients in the general anesthesia group (n = 21) had higher post-procedure prolactin levels and a longer mean time to lactation initiation (25 hours) than in the other groups (10.8 to 11.8 hours). Postpartum oxytocin levels in the nonmedicated vaginal delivery group were higher than in the general and spinal anesthesia groups.[4]
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