Last update Sept. 1, 2022

C8 H16 O2

Compatible

Safe product and/or breastfeeding is the best option.

Drug used in the treatment of various forms of epilepsy, in the manic phase of bipolar disorder and in the prophylaxis of migraine. Twice daily oral administration. Possible intravenous administration.

It is excreted in human milk in a clinically non-significant amount. (Abstract 238-240 2011, Meyer 1988, Tsuru 1988, Philbert 1985, von Unruh 1984, Nau 1981, Alexander 1979, Dickinson 1979)

Neither short-term nor long-term growth nor cognitive development problems have been observed in infants whose mothers took it. (Aydin 2015, Meador 2014, Mintzer 2011, Johannessen 2005, Piontek 2000, Wisner 1998, Philbert 1985, Alexander 1979)

The plasma levels of these infants were very low or below the detection limit. (Abstract 238-240 2011, Piontek 2000, Birnbaum 1999, Wisner 1998, Philbert 1985, Alexander 1979).

One infant developed thrombopenic purpura and anemia that recovered when the mother was withdrawn from valproate (Stahl 1997), but there were doubts as to whether it was post-viral idiopathic thrombopenic purpura.

A 4-month-old infant whose mother was taking valproate developed alopecia that disappeared when the mother discontinued the medication. (Govindan 2021)

Administration of valproic acid does not affect prolactin levels. (Hering 1992)

Various medical societies and expert consensus consider it generally safe to use this medication during breastfeeding. (LacMed, Uguz 2021, Crettenand 2018, Grover 2015, Davanzo 2014 and 2013, Rowe 2013, Veiby 2013, Pringsheim 2012, Mercadé 2012, O'Connor 2009, Harden 2009, Sharma 2009, Stowe 2007, Pennell 2006, Pack 2006, Even 2006, Tomson 2005, O'Brien 2005, Rubin 2004, Hägg 2000, Bar-Oz 2000, Austin 1998)

American Academy of Pediatrics: medication usually compatible with breastfeeding. (AAP 2001)

WHO 2002 List of Essential Medicines: compatible with breastfeeding. (WHO/UNICEF 2002)

Alternatives

We do not have alternatives for C8 H16 O2 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.

Group

C8 H16 O2 belongs to this group or family:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 144 daltons
Protein Binding 90 - 95 %
VD 0.1 - 0.4 l/Kg
pKa 5.14 -
Tmax 1 - 4 hours
8 - 20 hours
M/P ratio 0.01 - 0.4 -
Theoretical Dose 0.1 - 0.8 mg/Kg/d
Relative Dose 1 - 5 %
Ped.Relat.Dose 1.3 - 3 %

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. Govindan K, Mandadi GD. Alopecia in Breastfed Infant Possibly Due to Mother Getting Valproate. Indian J Pediatr. 2021 May;88(5):519-520. Abstract
  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. Rybakowski J, Cubała WJ, Gałecki P, Rymaszewska J, Samochowiec J, Szulc A, Dudek D. Recommendations of the Polish Psychiatric Association regarding the treatment of affective disorders in women of childbearing age. Part II: Bipolar disorder. Psychiatr Pol. 2019 Apr 30;53(2):263-276. Abstract Full text (link to original source)
  5. Crettenand M, Rossetti AO, Buclin T, Winterfeld U. [Use of antiepileptic drugs during breastfeeding : What do we tell the mother?] Nervenarzt. 2018 Abstract
  6. Aydin B, Nayir T, Sahin S, Yildiz A. Olanzapine and quetiapine use during breastfeeding: excretion into breast milk and safe breastfeeding strategy. J Clin Psychopharmacol. 2015 Apr;35(2):206-8. Abstract
  7. 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)
  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. Larsen ER, Damkier P, Pedersen LH, Fenger-Gron J, Mikkelsen RL, Nielsen RE, Linde VJ, Knudsen HE, Skaarup L, Videbech P. Use of psychotropic drugs during pregnancy and breast-feeding. Acta Psychiatr Scand Suppl. 2015 Abstract
  10. 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)
  11. Davanzo R, Bua J, Paloni G, Facchina G. Breastfeeding and migraine drugs. Eur J Clin Pharmacol. 2014 Abstract
  12. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  13. 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)
  14. 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)
  15. Pringsheim T, Davenport W, Mackie G, Worthington I, Aubé M, Christie SN, Gladstone J, Becker WJ; Canadian Headache Society Prophylactic Guidelines Development Group. Canadian Headache Society guideline for migraine prophylaxis. Can J Neurol Sci. 2012 Abstract Full text (in our servers)
  16. 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)
  17. Abstracts of the 10th Congress of the European Association for Clinical Pharmacology and Therapeutics. Zonisamide (P55), Lamotrigine (P238,239,244), Valproic (P238,240. Basic Clin Pharmacol Toxicol. 2011 Abstract Full text (link to original source) Full text (in our servers)
  18. 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)
  19. 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)
  20. 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)
  21. 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)
  22. 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)
  23. Stowe ZN. The use of mood stabilizers during breastfeeding. J Clin Psychiatry. 2007 Abstract Full text (link to original source)
  24. 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
  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. 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)
  28. 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)
  29. Tomson T. Gender aspects of pharmacokinetics of new and old AEDs: pregnancy and breast-feeding. Ther Drug Monit. 2005 Abstract
  30. 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
  31. 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)
  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. 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
  34. Hägg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000 Jun;22(6):425-40. Review. Abstract
  35. Piontek CM, Baab S, Peindl KS, Wisner KL. Serum valproate levels in 6 breastfeeding mother-infant pairs. J Clin Psychiatry. 2000 Abstract
  36. Birnbaum CS, Cohen LS, Bailey JW, Grush LR, Robertson LM, Stowe ZN. Serum concentrations of antidepressants and benzodiazepines in nursing infants: A case series. Pediatrics. 1999 Abstract Full text (link to original source)
  37. Austin MP, Mitchell PB. Use of psychotropic medications in breast-feeding women: acute and prophylactic treatment. Aust N Z J Psychiatry. 1998 Abstract
  38. Wisner KL, Perel JM. Serum levels of valproate and carbamazepine in breastfeeding mother-infant pairs. J Clin Psychopharmacol. 1998 Abstract
  39. Stahl MM, Neiderud J, Vinge E. Thrombocytopenic purpura and anemia in a breast-fed infant whose mother was treated with valproic acid. J Pediatr. 1997 Abstract
  40. Hering R, Gilad I, Laron Z, Kuritzky A. Effect of sodium valproate on the secretion of prolactin, cortisol and growth hormone in migraine patients. Cephalalgia. 1992 Abstract
  41. Meyer FP, Quednow B, Potrafki A, Walther H. [Pharmacokinetics of anticonvulsants in the perinatal period]. Zentralbl Gynakol. 1988 Abstract
  42. Tsuru N, Maeda T, Tsuruoka M. Three cases of delivery under sodium valproate--placental transfer, milk transfer and probable teratogenicity of sodium valproate. Jpn J Psychiatry Neurol. 1988 Abstract
  43. Philbert A, Pedersen B, Dam M. Concentration of valproate during pregnancy, in the newborn and in breast milk. Acta Neurol Scand. 1985 Abstract
  44. von Unruh GE, Froescher W, Hoffmann F, Niesen M. Valproic acid in breast milk: how much is really there? Ther Drug Monit. 1984 Abstract
  45. Nau H, Rating D, Koch S, Häuser I, Helge H. Valproic acid and its metabolites: placental transfer, neonatal pharmacokinetics, transfer via mother's milk and clinical status in neonates of epileptic mothers. J Pharmacol Exp Ther. 1981 Abstract
  46. Alexander FW. Sodium valproate and pregnancy. Arch Dis Child. 1979 Abstract Full text (link to original source) Full text (in our servers)
  47. Dickinson RG, Harland RC, Lynn RK, Smith WB, Gerber N. Transmission of valproic acid (Depakene) across the placenta: half-life of the drug in mother and baby. J Pediatr. 1979 May;94(5):832-5. No abstract available. Abstract

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