Last update Aug. 22, 2019

N01BB01

Compatible

Safe product and/or breastfeeding is the best option.

Topical anesthetic used for infiltrations and nerve blocks, including epidural.

It is excreted in breastmilk in clinically insignificant amounts (Bolat 2014, Ortega 1999, Baker 1989) and no problems have been observed in infants whose mothers were given it (Ortega 1999). The plasma levels of these infants were undetectable, even after intrapleural administration to the mother (Baker 1989).

In addition, its low oral bioavailability (due to minimal oral absorption) impedes transfer from breastmilk to infant plasma (Reece 2017).

According to the manufacturer, there is no risk for the infant due to the small amounts excreted in breastmilk (Pfizer 2018, AEMPS 2014).

There is controversy over whether drug analgesia during childbirth (epidural with local anesthetics with the addition or not of fentanyl) can affect the onset of breastfeeding, whether due to delayed lactogenesis II, or due to impairment of the infant's own competencies (French 2016, Herrera 2015, Howie 2006).

There are studies that show that with epidural anesthesia there is a greater risk of delaying the lactogenesis II period (stimulation of milk production) beyond 3 days (Herrera 2015, Lind 2014) and lower frequency and duration of breastfeeding (Thorvaldsen 2006), although they do not affect the initial weight loss of the newborn.
In some studies, the newborn appears to be at greater risk of delaying the first breastfeeding, due to having a higher body temperature and presenting irritability or drowsiness (Ransjö 2001). This being the case, more support will be needed for breastfeeding mothers who have received analgesia ante- and intra-partum (Zuppa 2014).

But other studies do not find significant problems in the initiation and maintenance of breastfeeding due to epidural anesthesia in childbirth or caesarean section (Mahomed 2019, Xu 2019, Grant 2019, Lee 2017, Mauri 2015, Shrestha 2014, Wilson 2010, Wieczorek 2010, Goma 2008, Chen 2008, Wang 2005, Chang 2005, Radzyminski 2003, Abouleish 1978).

The onset of breastfeeding was earlier and with more frequent feeds in vaginal delivery than after caesarean section and with epidural anesthesia than with general anesthesia (Kutlucan 2014, Sener 2003).
Regarding the epidural, general anesthesia was associated less frequently with breastfeeding and exclusive breastfeeding at 6 weeks (Orbach 2018) and at 6 months (Karasu 2018).

Prolactin levels decrease less with epidural anesthesia during childbirth (Jouppila 1980).

Postoperative pain control with continous epidural bupivacaine continues for 3 days after caesarean section improved breastmilk production and infant weight gain (Hirose 1996), but the opposite occurred when buprenorphine was associated (Hirose 1997).

The use of local anesthetics and regional anesthesia (spinal, epidural or peripheral block) decreases the need for opioids and other analgesics which can interfere with breastfeeding (Reece 2017).

There is consensus that there is greater milk production and greater neonate weight gain if pain is adequately controlled pharmacologically after delivery or cesarean section.

The manufacturer (Pfizer 2018, AEMPS 2014) and various medical associations and expert consensus consider the use of this medication to be safe during breastfeeding (Reece 2017, Cobb 2015, Lee 1993).

List of WHO essential medicines: compatible with breastfeeding (WHO / UNICEF 2002).


See below the information of this related product:

Alternatives

We do not have alternatives for N01BB01 since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

N01BB01 is Bupivacaine in ATC Code/s.

Is written in other languages:

N01BB01 is also known as

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 0 %
Molecular weight 288 daltons
Protein Binding 95 %
Tmax 0.2 - 0.5 hours
1.2 - 4.6 hours
Theoretical Dose 0.06 mg/Kg/d
Relative Dose 0.2 - 6 %
Ped.Relat.Dose 0.1 - 0.24 %

References

  1. Xu Q, Wu ZF, Yang NN, Shi M, Zhu ZQ. Impact of epidural analgesia during labor on breastfeeding initiation and continuation: a retrospective study. J Matern Fetal Neonatal Med. 2020 Nov;33(22):3816-3819. Abstract
  2. Grant GJ, Agoliati AP, Echevarria GC, Lax J. Epidural Analgesia to Facilitate Breastfeeding in a Grand Multipara. J Hum Lact. 2019 Feb;35(1):165-167. Abstract
  3. Mahomed K, Wild K, Brown C, Green A. Does fentanyl epidural analgesia affect breastfeeding: A prospective cohort study. Aust N Z J Obstet Gynaecol. 2019 Apr 8. Abstract
  4. Pfizer. Bupivacaine (Marcaine). Drug Summary. 2018 Full text (in our servers)
  5. Karasu D, Yilmaz C, Ozgunay SE, Cansabuncu S, Korfali G. A comparison of the effects of general anaesthesia and spinal anaesthesia on breastfeeding. C R Acad Bulg Sci . 2018;71:993-1000. Abstract Full text (in our servers)
  6. Orbach-Zinger S, Landau R, Davis A, Oved O, Caspi L, Fireman S, Fein S, Ioscovich A, Bracco D, Hoshen M, Eidelman LA. The Effect of Labor Epidural Analgesia on Breastfeeding Outcomes: A Prospective Observational Cohort Study in a Mixed-Parity Cohort. Anesth Analg. 2018 May 25. Abstract
  7. Lee AI, McCarthy RJ, Toledo P, Jones MJ, White N, Wong CA. Epidural Labor Analgesia-Fentanyl Dose and Breastfeeding Success: A Randomized Clinical Trial. Anesthesiology. 2017 Oct;127(4):614-624. Abstract
  8. Reece-Stremtan Sarah, Campos Matilde, Kokajko Lauren, and The Academy of Breastfeeding Medicine. Breastfeeding Medicine. ABM Clinical Protocol #15: Analgesia and Anesthesia for the Breastfeeding Mother, Revised 2017. Breastfeed Med. 2017 Nov;12(9):500-506. Full text (link to original source) Full text (in our servers)
  9. French CA, Cong X, Chung KS. Labor Epidural Analgesia and Breastfeeding: A Systematic Review. J Hum Lact. 2016 Aug;32(3):507-20. Abstract
  10. Mauri PA, Contini NN, Giliberti S, Barretta F, Consonni D, Negri M, Di Benedetto I. Intrapartum epidural analgesia and onset of lactation: a prospective study in an Italian birth centre. Matern Child Health J. 2015 Mar;19(3):511-8. Abstract
  11. Herrera-Gómez A, García-Martínez O, Ramos-Torrecillas J, De Luna-Bertos E, Ruiz C, Ocaña-Peinado FM. Retrospective study of the association between epidural analgesia during labour and complications for the newborn. Midwifery. 2015 Jun;31(6):613-6. Abstract
  12. Bolat E, Bestas A, Bayar MK, Ozcan S, Erhan OL, Ustundag B. Evaluation of levobupivacaine passage to breast milk following epidural anesthesia for cesarean delivery. Int J Obstet Anesth. 2014 Abstract
  13. Lind JN, Perrine CG, Li R. Relationship between Use of Labor Pain Medications and Delayed Onset of Lactation. J Hum Lact. 2014 Abstract Full text (link to original source)
  14. AEMPS-Braun. Bupivacaína. Ficha técnica. 2014 Full text (in our servers)
  15. Kutlucan L, Seker İS, Demiraran Y, Ersoy Ö, Karagöz İ, Sezen G, Köse SA. Effects of different anesthesia protocols on lactation in the postpartum period. J Turk Ger Gynecol Assoc. 2014 Dec 1;15(4):233-8. Abstract Full text (link to original source)
  16. Shrestha B, Devgan A, Sharma M. Effects of maternal epidural analgesia on the neonate - a prospective cohort study. Ital J Pediatr. 2014 Abstract Full text (link to original source) Full text (in our servers)
  17. Zuppa A, Alighieri G, Riccardi R, Cavani M, Iafisco A, Cota F, Romagnoli C. Epidural analgesia, neonatal care and breastfeeding. Ital J Pediatr. 2014 Abstract Full text (link to original source) Full text (in our servers)
  18. Gizzo S, Di Gangi S, Saccardi C, Patrelli TS, Paccagnella G, Sansone L, Barbara F, D'Antona D, Nardelli GB. Epidural analgesia during labor: impact on delivery outcome, neonatal well-being, and early breastfeeding. Breastfeed Med. 2012 Aug;7:262-8. Abstract
  19. Wieczorek PM, Guest S, Balki M, Shah V, Carvalho JC. Breastfeeding success rate after vaginal delivery can be high despite the use of epidural fentanyl: an observational cohort study. Int J Obstet Anesth. 2010 Jul;19(3):273-7. Abstract
  20. Wilson MJ, MacArthur C, Cooper GM, Bick D, Moore PA, Shennan A; COMET Study Group UK. Epidural analgesia and breastfeeding: a randomised controlled trial of epidural techniques with and without fentanyl and a non-epidural comparison group. Anaesthesia. 2010 Abstract Full text (link to original source) Full text (in our servers)
  21. Chen YM, Li Z, Wang AJ, Wang JM. [Effect of labor analgesia with ropivacaine on the lactation of paturients]. Zhonghua Fu Chan Ke Za Zhi. 2008 Jul;43(7):502-5. Chinese. Abstract
  22. Goma HM, Said RN, El-Ela AM. Study of the newborn feeding behaviors and fentanyl concentration in colostrum after an analgesic dose of epidural and intravenous fentanyl in cesarean section. Saudi Med J. 2008 May;29(5):678-82. Abstract
  23. Torvaldsen S, Roberts CL, Simpson JM, Thompson JF, Ellwood DA. Intrapartum epidural analgesia and breastfeeding: a prospective cohort study. Int Breastfeed J. 2006 Abstract Full text (link to original source) Full text (in our servers)
  24. Howie WO, McMullen PC. Breastfeeding problems following anesthetic administration. J Perinat Educ. 2006 Abstract Full text (link to original source) Full text (in our servers)
  25. Wang BP, Li QL, Hu YF. [Impact of epidural anesthesia during delivery on breast feeding]. Di Yi Jun Yi Da Xue Xue Bao. 2005 Abstract Full text (link to original source) Full text (in our servers)
  26. Chang ZM, Heaman MI. Epidural analgesia during labor and delivery: effects on the initiation and continuation of effective breastfeeding. J Hum Lact. 2005 Abstract
  27. Nice FJ, De Eugenio D, Dimino TA, Freeny IC, Rovnack MB, Gromelski JS. Medications and Breast-Feeding: A Guide for Pharmacists, Pharmacy Technicians, and Other Healthcare Professionals. Part I. J Pharm Technol 2004;20:17-27. doi: 10.1177/875512250402000106.
  28. Sener EB, Guldogus F, Karakaya D, Baris S, Kocamanoglu S, Tur A. Comparison of neonatal effects of epidural and general anesthesia for cesarean section. Gynecol Obstet Invest. 2003 Abstract
  29. Radzyminski S. The effect of ultra low dose epidural analgesia on newborn breastfeeding behaviors. J Obstet Gynecol Neonatal Nurs. 2003 Abstract
  30. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Abstract Full text (link to original source) Full text (in our servers)
  31. Ransjö-Arvidson AB, Matthiesen AS, Lilja G, Nissen E, Widström AM, Uvnäs-Moberg K. Maternal analgesia during labor disturbs newborn behavior: effects on breastfeeding, temperature, and crying. Birth. 2001 Abstract
  32. Ortega D, Viviand X, Lorec AM, Gamerre M, Martin C, Bruguerolle B. Excretion of lidocaine and bupivacaine in breast milk following epidural anesthesia for cesarean delivery. Acta Anaesthesiol Scand. 1999 Abstract
  33. Hirose M, Hosokawa T, Tanaka Y. Extradural buprenorphine suppresses breast feeding after caesarean section. Br J Anaesth. 1997 Abstract Full text (link to original source) Full text (in our servers)
  34. Hirose M, Hara Y, Hosokawa T, Tanaka Y. The effect of postoperative analgesia with continuous epidural bupivacaine after cesarean section on the amount of breast feeding and infant weight gain. Anesth Analg. 1996 Abstract
  35. Lee JJ, Rubin AP. Breast feeding and anaesthesia. Anaesthesia. 1993 Jul;48(7):616-25. Review. Abstract Full text (link to original source) Full text (in our servers)
  36. Baker PA, Schroeder D. Interpleural bupivacaine for postoperative pain during lactation. Anesth Analg. 1989 Sep;69(3):400-2. No abstract available. Abstract
  37. Jouppila R, Jouppila P, Moilanen K, Pakarinen A. The effect of segmental epidural analgesia on maternal prolactin during labour. Br J Obstet Gynaecol. 1980 Abstract
  38. Abouleish E, Donck AV, Meeuwis H, Taylor F. Effect of anaesthesia for delivery on the weight of infants during the first 5 days of life. Br J Anaesth. 1978 Abstract

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