Fospropofol use while Breastfeeding
Drugs containing Fospropofol: Lusedra
Medically reviewed by Drugs.com. Last updated on May 23, 2020.
Fospropofol Levels and Effects while Breastfeeding
Summary of Use during Lactation
No information is available on the clinical use of fospropofol during breastfeeding. However, fospropofol is rapidly metabolized to propofol in the body. Amounts of propofol in milk are very small and are not expected to be absorbed by the infant. Although one expert panel recommends withholding nursing for an unspecified time after propofol administration, most recommend that breastfeeding can be resumed as soon as the mother has recovered sufficiently from general anesthesia to nurse and that discarding milk is unnecessary. 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 propofol as a component for induction may delay the onset of lactation.In one study, breastfeeding before general anesthesia induction reduced requirements of propofol and sevoflurane compared to those of nursing mothers whose breastfeeding was withheld or nonnursing women. In one case, milk was noted to be green in color 8 hours after a procedure in which propofol was administered; however, several other medications were also used during the procedure.
Fospropofol is rapidly metabolized to propofol, formaldehyde and phosphate after administration. Information on propofol during breastfeeding is listed below. Maternal Levels. Five women who had undergone general anesthesia with propofol intravenously shortly after delivery had colostrum propofol levels measured. All of the women received 2 mg/kg intravenously over 20 seconds at time zero followed by a continuous infusion. In 3 women who received 0.25 to 0.37 mg/kg/minute, propofol was detectable in colostrum, but not quantifiable because of technical difficulties. In a woman who received 0.42 mg/kg/minute for 7 minutes, the highest colostrum level was 1.53 mg/L at 15 minutes after the start of the infusion. Colostrum levels decreased to 0.12 mg/L over the next 8 hours. Another woman who received 0.18 mg/kg/minute for 6 hours, the highest colostrum level was 4.91 mg/L at 30 minutes after the start of the infusion.
Four women received a single intravenous bolus dose of propofol 2.5 mg/kg prior to cesarean section. Colostrum levels averaged 0.17 mg/L (range 0.14 to 0.24 mg/L) in 3 of the women 4 hours after the dose and 0.14 mg/L (range 0.089 to 0.19 mg/L) in 4 of the women 8 hours after the dose. In the same report, 3 women received a bolus dose of propofol 2.5 mg/kg followed by a continuous infusion of 5 mg/kg/hour. In one patient, colostrum level was 0.33 mg/L at 4 hours after the bolus; a second patient had levels of 0.74 mg/L at 5 hours and 0.048 mg/L at 8 hours after the bolus; a third patient had a colostrum level of 0.036 mg/L at 6 hours after the bolus.
Five women who were 6 to 15 weeks postpartum were given a single dose of 2.5 mg/kg of propofol intravenously before undergoing general anesthesia. Several milk samples were collected between 5 and 24 hours after the injection from each woman. The authors estimated that the infants would receive an average of 0.0052 mg/kg in the 24 hours after a single dose of propofol. This corresponds to 0.02% of the maternal weight-adjusted dosage. The women's milk output following the surgical procedure was less than half of the normal milk output of nursing mothers. The authors concluded that this amount of propofol in milk is unlikely to affect a healthy, term infant. The infants of mothers not undergoing a surgical procedure might receive a greater dose of propofol in breastmilk, but it would be unlikely to be a large dose.
A woman received 474 mg of propofol by controlled infusion during a procedure to terminate an ectopic pregnancy. The first milk she pumped 8 hours after the procedure was green in color. Although the authors suspect that propofol was the cause of the discoloration, the woman had also received several other medications during the procedure. Thirty hours later, propofol was detected in a milk sample at a concentration of 24 mcg/L, completely as unconjugated propofol.
Two mothers who were breastfeeding their infants were given propofol doses that targeted a serum concentration of 6.5 mcg/L for anesthesia induction. Propofol was stopped as xenon anesthesia was started. One mother received a total of 350 mg of propofol intravenously and had an operative time of 35 minutes. Her milk propofol level was 0.13 mg/L at 300 minutes after extubation. The other mother received a total of 443 mg of propofol intravenously and had an operative time of 35 minutes. Her milk propofol level was 2.78 mg/L at 90 minutes after extubation and 0.84 mg/L 300 minutes after extubation.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Four mothers who were breastfeeding their infants received propofol as part of their general anesthesia for surgical procedures. All patients also received intravenous remifentanil and rocuronium, and inhaled xenon as part of the anesthesia. They were given doses of propofol that targeted a serum concentration of 6.5 mcg/L for induction and stopped as xenon anesthesia was started. Operation times ranged from 35 to 45 minutes. Individual infants were first breastfed as follows: 1.5 hours, 2.8 hours, 4.6 hours, and 5 hours after extubation. No signs of sedation were observed in any of the infants.
Effects on Lactation and Breastmilk
A woman underwent emergency laparoscopic surgery using propofol as well as fentanyl, remifentanil, mivacurium, and dipyrone during the surgery and metamizole, piritramide, dipyrone, butylscopolamine, and metoclopramide postoperatively. Eight hours postoperatively, her milk turned bluish green, then green. Both propofol and metoclopramide have caused green urine. Thirty hours after the milk color change, propofol but not metoclopramide, was detected in milk.
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 rocuronium 0.6 mg/kg for induction, followed by sevoflurane and rocuronium 0.15 mg/kg as needed. Fentanyl 1 to 1.5 mcg/kg was administered after delivery. 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.
A randomized, double-blind study compared the effects of intravenous propofol 0.25 mg/kg, ketamine 0.25 mg/kg, ketamine 25 mg plus propofol 25 mg, and saline placebo for pain control in mothers post-cesarean section in mothers post-cesarean section. A single dose was given immediately after clamping of the umbilical cord. The time to the first breastfeeding was 58 minutes in those who received placebo, 42.6 minutes with propofol and 25.8 minutes with propofol plus ketamine. The time was significantly shorter than the other groups with the combination.
Vargo JJ, Delegge MH, Feld AD et al. Multisociety sedation curriculum for gastrointestinal endoscopy. Gastroenterology. 2012;143:e18-41. [PubMed: 22624720]
Dailland P, Cockshott ID, Didier Lirzin J et al. Intravenous propofol during cesarean section: placental transfer, concentrations in breast milk, and neonatal effects. A preliminary study. Anesthesiology. 1989;71:827-34. [PubMed: 2589672]
Nitsun M, Szokol JW, Saleh HJ, Murphy GS, Vender JS, Luong L et al. Pharmacokinetics of midazolam, propofol, and fentanyl transfer to human breast milk. Clin Pharmacol Ther. 2006;79:549-57. [PubMed: 16765143]
Shergill AK, Ben-Menachem T, Chandrasekhara V et al. Guidelines for endoscopy in pregnant and lactating women. Gastrointest Endosc. 2012;76:18-24. [PubMed: 22579258]
Bhaskara B, Dayananda VP, Kannan S et al. Effect of breastfeeding on haemodynamics and consumption of propofol and sevoflurane: A state entropy guided comparative study. Indian J Anaesth. 2016;60:180-6. [PMC free article: PMC4800934] [PubMed: 27053781]
Schmitt JP, Schwoerer D, Diemunsch P et al. [Passage of propofol in the colostrum. Preliminary data]. Ann Fr Anesth Reanim. 1987;6:267-8. [PubMed: 3498397]
Birkholz T, Eckardt G, Renner S et al. Green breast milk after propofol administration. Anesthesiology. 2009;111:1168-9. [PubMed: 19858894]
Stuttmann R, Schafer C, Hilbert P et al. The breast feeding mother and xenon anaesthesia: four case reports. Breast feeding and xenon anaesthesia. BMC Anesthesiol. 2010;10:1. [PMC free article: PMC2837001] [PubMed: 20167123]
Kutlucan L, Seker IS, Demiraran Y et al. Effects of different anesthesia protocols on lactation in the postpartum period. J Turkish German Gynecol Assoc Artemis. 2014;15:233-8. [PMC free article: PMC4285212] [PubMed: 25584032]
Jaafarpour M, Vasigh A, Khajavikhan J et al. Effect of ketofol on pain and complication after Caesarean delivery under spinal anaesthesia: A randomized double-blind clinical trial. J Clin Diagn Res. 2017;11:UC04-UC07. DOI: 10.7860/JCDR/2017/21437.9434. [PMC free article: PMC5427408] [PubMed: 28511482] [CrossRef]
CAS Registry Number
Hypnotics and Sedatives
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.