Last update June 21, 2022

N03AF01

Compatible

Safe product and/or breastfeeding is the best option.

It is a dibenzazepine derivative with antiepileptic and psychotropic properties. It is used in the treatment of certain epilepsies, trigeminal neuralgia, multiple sclerosis pain, and bipolar disorder. Oral administration 2 to 4 times a day.

It is excreted in breast milk in small amount. (Kacirova 2021, Antonucci 2018, Lopes 2012, Zhao 2010, Shimoyama 2000, Brent 1998, Merlob 1992, Meyer 1988, Froescher 1984, Kuhnz 1983, Kok 1982, Niebyl 1979, Kaneko 1979, Pynnönen 1977 y 1975)

Most infants do not have short-term or long-term clinical or developmental problems (Vajda 2014, Meador 2014 & 2010, Veiby 2013, Johannessen 2005, Wisner 1998, Ito 1993, Niebyl 1979, Pynnönen 1977), although isolated cases of drowsiness, poor feeding, and transient liver dysfunction with cholestasis have been reported. (Antonucci 2018, Frey 2002, Merlob 1992, Frey 1990, Kuhnz 1983)

Plasma levels in the infants were between 5% and 40% of the corresponding maternal levels and always below the lower limit of the usual therapeutic range (Mercadé 2012: 4-12 mg/L) for carbamazepine. (Kacirova 2021, Birnbaum 2020, Antonucci 2018, Grover 2015, Wisner 1998, Merlob 1992, Kuhnz 1983, Kok 1982, Pynnönen 1977 y 1975)

One case of Deprivation Syndrome has been reported after sudden discontinuation of medication. (Knott 1987)

Several medical societies and expert authors consider the use of this medication possible during breastfeeding (Hale, LactMed, Uguz 2021, Crettenand 2018, Briggs 2015, Schaefer 2015, Davanzo 2013, Rowe 2013, Mintzer 2011, O'Connor 2009, Harden 2009, Sharma 2009, Even 2006, Pack 2006, Pennell 2006, O'Brien 2005, Bar-Oz 2000, Hägg 2000). The American Academy of Pediatrics rates it as usually compatible with Breastfeeding (AAP 2001). Eleventh WHO Model List of Essential Drugs 2002: Compatible with breastfeeding. (WHO 2002)


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Alternatives

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

N03AF01 is Carbamazepine in ATC Code/s.

Is written in other languages:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 75 - 85 %
Molecular weight 236 daltons
Protein Binding 75 - 80 %
VD 0.7 - 1.4 l/Kg
pKa 15.96 -
Tmax 6 ± 2 hours
12 - 17; (1 dosis: 25-40) hours
M/P ratio 0.2 -0.9 -
Theoretical Dose 0.1 - 0.7 mg/Kg/d
Relative Dose 0.8 - 8.3 %
Ped.Relat.Dose 3.75 - 6.75 %

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. Uguz F. A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation. Am J Ther. 2021 Jan-Feb 01;28(1):e118-e126. Abstract
  4. Kacirova I, Grundmann M, Brozmanova H. Therapeutic monitoring of carbamazepine and its active metabolite during the 1st postnatal month: Influence of drug interactions. Biomed Pharmacother. 2021 May;137:111412. Abstract Full text (link to original source) Full text (in our servers)
  5. Birnbaum AK, Meador KJ, Karanam A, Brown C, May RC, Gerard EE, Gedzelman ER, Penovich PE, Kalayjian LA, Cavitt J, Pack AM, Miller JW, Stowe ZN, Pennell PB; MONEAD Investigator Group.. Antiepileptic Drug Exposure in Infants of Breastfeeding Mothers With Epilepsy. JAMA Neurol. 2020 Apr 1;77(4):441-450. Abstract Full text (link to original source)
  6. Antonucci R, Cuzzolin L, Manconi A, Cherchi C, Oggiano AM, Locci C. Maternal Carbamazepine Therapy and Unusual Adverse Effects in a Breastfed Infant. Breastfeed Med. 2018 Mar;13(2):155-157. Abstract
  7. Crettenand M, Rossetti AO, Buclin T, Winterfeld U. [Use of antiepileptic drugs during breastfeeding : What do we tell the mother?] Nervenarzt. 2018 Abstract
  8. 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)
  9. Grover S, Avasthi A. Mood stabilizers in pregnancy and lactation. Indian J Psychiatry. 2015 Abstract Full text (link to original source) Full text (in our servers)
  10. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, Third Edition. 2015
  11. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  12. Vajda F. Epilepsy: Effects of exposure to antiepileptic drugs during development. Nat Rev Neurol. 2014 Jan;10(1):11-2. Abstract
  13. Meador KJ, Baker GA, Browning N, Cohen MJ, Bromley RL, Clayton-Smith J, Kalayjian LA, Kanner A, Liporace JD, Pennell PB, Privitera M, Loring DW; Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) Study Group. Breastfeeding in children of women taking antiepileptic drugs: cognitive outcomes at age 6 years. JAMA Pediatr. 2014 Abstract Full text (link to original source) Full text (in our servers)
  14. 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)
  15. Veiby G, Engelsen BA, Gilhus NE. Early child development and exposure to antiepileptic drugs prenatally and through breastfeeding: a prospective cohort study on children of women with epilepsy. JAMA Neurol. 2013 Abstract Full text (link to original source) Full text (in our servers)
  16. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  17. Lopes BR, Barreiro JC, Baraldi PT, Cass QB. Quantification of carbamazepine and its active metabolite by direct injection of human milk serum using liquid chromatography tandem ion trap mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2012 Abstract
  18. 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)
  19. Mintzer S. To test our guess that breast is best: anticonvulsants and breastfeeding. Epilepsy Curr. 2011 Abstract Full text (link to original source) Full text (in our servers)
  20. Meador KJ, Baker GA, Browning N, Clayton-Smith J, Combs-Cantrell DT, Cohen M, Kalayjian LA, Kanner A, Liporace JD, Pennell PB, Privitera M, Loring DW; NEAD Study Group. Effects of breastfeeding in children of women taking antiepileptic drugs. Neurology. 2010 Nov 30;75(22):1954-60. Abstract Full text (link to original source) Full text (in our servers)
  21. Zhao M, Yang L, Wei Y, Xiong X, Zhou Y, Zhai SD. [A case report of monitoring on carbamazepine in breast feeding woman]. Beijing Da Xue Xue Bao. 2010 Abstract Full text (link to original source) Full text (in our servers)
  22. Sharma V, Burt VK, Ritchie HL. Bipolar II postpartum depression: Detection, diagnosis, and treatment. Am J Psychiatry. 2009 Abstract Full text (link to original source) Full text (in our servers)
  23. 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)
  24. 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)
  25. Pack AM. Therapy insight: clinical management of pregnant women with epilepsy. Nat Clin Pract Neurol. 2006 Abstract
  26. 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)
  27. Even C, Dorocant ES, Thuile J, Kalck-stern M, Guelfi JD. [Pregnancy, breast feeding and mood stabilisers: review and recommendations for practice]. Encephale. 2006 Abstract
  28. 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)
  29. Johannessen SI, Helde G, Brodtkorb E. Levetiracetam concentrations in serum and in breast milk at birth and during lactation. Epilepsia. 2005 May;46(5):775-7. Abstract Full text (link to original source) Full text (in our servers)
  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. Frey B, Braegger CP, Ghelfi D. Neonatal cholestatic hepatitis from carbamazepine exposure during pregnancy and breast feeding. Ann Pharmacother. 2002 Abstract
  32. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  33. Shimoyama R, Ohkubo T, Sugawara K. Monitoring of carbamazepine and carbamazepine 10,11-epoxide in breast milk and plasma by high-performance liquid chromatography. Ann Clin Biochem. 2000 Abstract
  34. 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
  35. Hägg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000 Jun;22(6):425-40. Review. Abstract
  36. Brent NB, Wisner KL. Fluoxetine and carbamazepine concentrations in a nursing mother/infant pair. Clin Pediatr (Phila). 1998 Abstract
  37. Wisner KL, Perel JM. Serum levels of valproate and carbamazepine in breastfeeding mother-infant pairs. J Clin Psychopharmacol. 1998 Abstract
  38. Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993 May;168(5):1393-9. Abstract
  39. Merlob P, Mor N, Litwin A. Transient hepatic dysfunction in an infant of an epileptic mother treated with carbamazepine during pregnancy and breastfeeding. Ann Pharmacother. 1992 Abstract
  40. Frey B, Schubiger G, Musy JP. Transient cholestatic hepatitis in a neonate associated with carbamazepine exposure during pregnancy and breast-feeding. Eur J Pediatr. 1990 Abstract
  41. Meyer FP, Quednow B, Potrafki A, Walther H. [Pharmacokinetics of anticonvulsants in the perinatal period]. Zentralbl Gynakol. 1988 Abstract
  42. Knott C, Reynolds F, Clayden G. Infantile spasms on weaning from breast milk containing anticonvulsants. Lancet. 1987 Abstract
  43. Froescher W, Eichelbaum M, Niesen M, Dietrich K, Rausch P. Carbamazepine levels in breast milk. Ther Drug Monit. 1984 Abstract
  44. Kuhnz W, Jäger-Roman E, Rating D, Deichl A, Kunze J, Helge H, Nau H. Carbamazepine and carbamazepine-10,11- epoxide during pregnancy and postnatal period in epileptic mother and their nursed infants: pharmacokinetics and clinical effects. Pediatr Pharmacol (New York). 1983 Abstract
  45. Kok TH, Taitz LS, Bennett MJ, Holt DW. Drowsiness due to clemastine transmitted in breast milk. Lancet. 1982 Abstract
  46. 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)
  47. Niebyl JR, Blake DA, Freeman JM, Luff RD. Carbamazepine levels in pregnancy and lactation. Obstet Gynecol. 1979 Abstract
  48. Pynnönen S, Kanto J, Sillanpää M, Erkkola R. Carbamazepine: placental transport, tissue concentrations in foetus and newborn, and level in milk. Acta Pharmacol Toxicol (Copenh). 1977 Abstract
  49. Pynnönen S, Sillanpää M. Letter: Carbamazepine and mother's milk. Lancet. 1975 Abstract

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