Last update Feb. 2, 2025

苯巴比妥

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Long-acting barbiturate due to its long half-life. Used in epilepsy as an anticonvulsant. Oral, intravenous and intramuscular administration.

Excreted in breast milk in highly variable proportions, reaching concentrations that could be clinically significant  (O'Connor 2005, Shimoyama 2000, Gomita 1995, , Meyer 1988, Kaneko 1979). More recent authors consider the passage of phenobarbital into breast milk to be of no clinical concern. (Davanzo 2013, Mercadé 2012, Harden 2009)

Plasma levels exceeding the limits of the therapeutic range (15-40 µg/ml) have been measured in the plasma of infants born to mothers taking phenobarbital. (Pediamecum 2025, Pote 2004, Gomita 1995, Kuhnz 1988)

Sedation described in infants of mothers taking it but also withdrawal syndrome with spasms after sudden weaning, mostly in newborns. (Rauchenzauner 2011, Kuhnz 1988, Juul 1969, Knott 1987)

Should be used with caution during breastfeeding (Pennell 2006). To monitor alertness and sufficient feeding in infants. Monitoring of plasma levels in the infant may be indicated, both if sedation occurs and to guide progressive weaning.

Several medical societies and expert authors consider the use of phenobarbital during breastfeeding to be compatible with careful monitoring of the infant, including plasma levels if there are signs of drowsiness, poor feeding or poor weight gain. (Crettenand 2018, Veiby 2015, Davanzo 2013, Mercadé 2012, Rauchenzauner 2011, Pack 2006, O'Brien 2005, Moretti 2000)

WHO essential medicines list: compatible with breastfeeding. (WHO-UNICEF 2002)

Other antiepileptic drugs with more favourable pharmacological profiles are preferable during breastfeeding. (LactMed, Hale, Rubin 2004, Hägg 2000, Pons 1994), especially if the mother was not taking phenobarbital during pregnancy.


See below the information of this related product:

  • Maternal Epilepsy (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)

Alternatives

  • Carbamazepine (Safe product and/or breastfeeding is the best option.)
  • Gabapentin (Safe product and/or breastfeeding is the best option.)
  • Lamotrigine (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)
  • Lorazepam (Safe product and/or breastfeeding is the best option.)
  • Midazolam (Safe product and/or breastfeeding is the best option.)
  • Oxazepam (Safe product and/or breastfeeding is the best option.)
  • Oxcarbazepine (Safe product and/or breastfeeding is the best option.)
  • Phenytoin (Safe product and/or breastfeeding is the best option.)
  • Valproate, Valproic Acid (Safe product and/or breastfeeding is the best option.)
  • Vigabatrin (Safe product and/or breastfeeding is the best option.)

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

苯巴比妥 is Phenobarbital in Chinese.

Is written in other languages:

苯巴比妥 is also known as

Group

苯巴比妥 belongs to this group or family:

Tradenames

Main tradenames from several countries containing 苯巴比妥 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 70 - 90 %
Molecular weight 232 daltons
Protein Binding 20 - 45 %
VD 0.7 (0.3 - 1) l/Kg
Tmax 8 - 12 hours
96 (50 - 120) hours
M/P ratio 0.4 - 0.6 -
Theoretical Dose 0.4 - 1.14 mg/Kg/d
Relative Dose 12 - >100 %
Ped.Relat.Dose 5 - 23 %

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on April 16, 2024 Full text (link to original source)
  2. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  3. Tomson T, Battino D, Bromley R, Kochen S, Meador KJ, Pennell PB, Thomas SV. Breastfeeding while on treatment with antiseizure medications: a systematic review from the ILAE Women Task Force. Epileptic Disord. 2022 Dec 1;24(6):1020-1032. Abstract
  4. Crettenand M, Rossetti AO, Buclin T, Winterfeld U. [Use of antiepileptic drugs during breastfeeding : What do we tell the mother?] Nervenarzt. 2018 Abstract
  5. Veiby G, Bjørk M, Engelsen BA, Gilhus NE. Epilepsy and recommendations for breastfeeding. Seizure. 2015 May;28:57-65. Abstract Full text (link to original source)
  6. Davanzo R, Dal Bo S, Bua J, Copertino M, Zanelli E, Matarazzo L. Antiepileptic drugs and breastfeeding. Ital J Pediatr. 2013 Abstract Full text (link to original source) Full text (in our servers)
  7. Mercadé Cerdá JM, Sancho Rieger J, Mauri Llerda JA, López González FJ,Salas Puig X. Guías diagnósticas y terapéuticas de la Sociedad Española de Neurología 2012. 1. Guía oficial de práctica clínica en epilepsia. Guías SEN 2012 Full text (in our servers)
  8. Rauchenzauner M, Kiechl-Kohlendorfer U, Rostasy K, Luef G. Old and new antiepileptic drugs during pregnancy and lactation--report of a case. Epilepsy Behav. 2011 Abstract
  9. O'Connor SE, Zupanc ML. Women and epilepsy. J Pediatr Pharmacol Ther. 2009 Abstract Full text (link to original source) Full text (in our servers)
  10. Harden CL, Pennell PB, Koppel BS, Hovinga CA, Gidal B, Meador KJ, Hopp J, Ting TY, Hauser WA, Thurman D, Kaplan PW, Robinson JN, French JA, Wiebe S, Wilner AN, Vazquez B, Holmes L, Krumholz A, Finnell R, Shafer PO, Le Guen C; American Academy of Neurology; et al. Practice parameter update: management issues for women with epilepsy--focus on pregnancy (an evidence-based review): vitamin K, folic acid, blood levels, and breastfeeding: report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of... Neurology. 2009 Abstract Full text (link to original source) Full text (in our servers)
  11. Pack AM. Therapy insight: clinical management of pregnant women with epilepsy. Nat Clin Pract Neurol. 2006 Abstract
  12. Pennell PB. 2005 AES annual course: evidence used to treat women with epilepsy. Epilepsia. 2006 Abstract Full text (link to original source) Full text (in our servers)
  13. O'Brien MD, Gilmour-White SK. Management of epilepsy in women. Postgrad Med J. 2005 Abstract Full text (link to original source) Full text (in our servers)
  14. Tomson T. Gender aspects of pharmacokinetics of new and old AEDs: pregnancy and breast-feeding. Ther Drug Monit. 2005 Abstract
  15. Pote M, Kulkarni R, Agarwal M. Phenobarbital toxic levels in a nursing neonate. Indian Pediatr. 2004 Sep;41(9):963-4. No abstract available. Abstract Full text (link to original source)
  16. Rubin ET, Lee A, Ito S. When breastfeeding mothers need CNS-acting drugs. Can J Clin Pharmacol. 2004 Fall;11(2):e257-66. Epub 2004 Dec 8. Abstract
  17. Pennell PB. Antiepileptic drug pharmacokinetics during pregnancy and lactation. Neurology. 2003 Abstract
  18. 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)
  19. Moretti ME, Lee A, Ito S. Which drugs are contraindicated during breastfeeding? Practice guidelines. Can Fam Physician. 2000 Sep;46:1753-7. Review. Abstract Full text (link to original source) Full text (in our servers)
  20. Hägg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000 Jun;22(6):425-40. Review. Abstract
  21. Bar-Oz B, Nulman I, Koren G, Ito S. Anticonvulsants and breast feeding: a critical review. Paediatr Drugs. 2000 Mar-Apr;2(2):113-26. Review. Abstract
  22. Shimoyama R, Ohkubo T, Sugawara K. Characteristics of interaction between barbiturate derivatives and various sorbents on liquid chromatography and determination of phenobarbital in Japanese human breast milk. J Liq Chromatogr Relat Technol 2000;23:587-99. Abstract
  23. Gomita Y, Furuno K, Araki Y, Yamatogi Y, Ohtahara S. Phenobarbital in Sera of Epileptic Mothers and Their Infants. Am J Ther. 1995 Dec;2(12):968-971. Abstract
  24. Pons G, Rey E, Matheson I. Excretion of psychoactive drugs into breast milk. Pharmacokinetic principles and recommendations. Clin Pharmacokinet. 1994 Abstract
  25. Kuhnz W, Koch S, Helge H, Nau H. Primidone and phenobarbital during lactation period in epileptic women: total and free drug serum levels in the nursed infants and their effects on neonatal behavior. Dev Pharmacol Ther. 1988;11(3):147-54. Abstract
  26. Meyer FP, Quednow B, Potrafki A, Walther H. [Pharmacokinetics of anticonvulsants in the perinatal period]. Zentralbl Gynakol. 1988 Abstract
  27. Knott C, Reynolds F, Clayden G. Infantile spasms on weaning from breast milk containing anticonvulsants. Lancet. 1987 Abstract
  28. Kaneko S, Sato T, Suzuki K. The levels of anticonvulsants in breast milk. Br J Clin Pharmacol. 1979 Abstract Full text (link to original source) Full text (in our servers)
  29. Juul S. [Barbiturate poisoning via breast milk?]. Ugeskr Laeger. 1969 Dec 18;131(51):2257-8. Danish. No abstract available. Abstract

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