Last update Aug. 13, 2024

Primidone

Likely Compatibility

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

Primidone is an antiepileptic used to treat focal, psychomotor, and tonic-clonic type epileptic seizures and essential tremor. It is partially metabolized to phenobarbital.  Oral administration in one or two daily doses.

It is excreted in breast milk in moderate amounts, with a relative dose of about 10%, sufficient to cause problems to the infant. (Harden 2009, Moretti 2000, Meyer 1988, Kaneko 1979, Niebyl 1979)

Plasma levels within the therapeutic range have been measured in some infants born to mothers taking primidone. (LactMed, Kuhnz 1988, Nau 1980)

Several cases of sedation, poor feeding and one case of death by suffocation in infants have been described, presumably attributed to primidone taken by their mothers.. (LacMed, Kuhnz 1984)

Newborns of mothers who took primidone during pregnancy and were not breastfed had withdrawal symptoms. (Rauchenzauner 2011, Kuhnz 1988)

A newborn whose mother was taking Primidone and carbamazepine during the first postpartum month did not present any problems. (Niebyl 1979)

Some authors consider this medication prorbablementre compatible with lactation, monitoring the appearance of sedation, apnea and feeding difficulties, especially during the neonatal period and assessing the desirability of measuring plasma levels in the infant. (LactMed, Crettenand 2018, Veiby 2015, Davanzo 2013, O'Connor 2009, Pennell 2006, O'Brien 2005)

Alternatives

  • Carbamazepine (Safe product and/or breastfeeding is the best option.)
  • Gabapentin (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.)

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.

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Other names

Primidone is also known as


Primidone in other languages or writings:

Group

Primidone belongs to this group or family:

Tradenames

Main tradenames from several countries containing Primidone in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 80 %
Molecular weight 218 daltons
Protein Binding 11 - 14 %
VD 0.5 - 0.8 l/Kg
pKa 11.5 -
Tmax 2 - 4 hours
T½ 7 - 22 hours
M/P ratio 0.5 - 1.1 -
Theoretical Dose 0.4 - 1.65 mg/Kg/d
Relative Dose 7. 2 -9.9 %
Ped.Relat.Dose 1.6 - 4.0 %

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. Crettenand M, Rossetti AO, Buclin T, Winterfeld U. [Use of antiepileptic drugs during breastfeeding : What do we tell the mother?] Nervenarzt. 2018 Abstract
  3. IARC - WHO. International Agency for research on Cancer. Some Drugs and Herbal Products. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 108. 2016 Full text (link to original source)
  4. 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)
  5. 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)
  6. 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)
  7. 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
  8. 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)
  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. 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)
  11. 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)
  12. 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)
  13. 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
  14. Meyer FP, Quednow B, Potrafki A, Walther H. [Pharmacokinetics of anticonvulsants in the perinatal period]. Zentralbl Gynakol. 1988 Abstract
  15. Nau H, Rating D, Häuser I, Jäger E, Koch S, Helge H. Placental transfer and pharmacokinetics of primidone and its metabolites phenobarbital, PEMA and hydroxyphenobarbital in neonates and infants of epileptic mothers. Eur J Clin Pharmacol. 1980 Jul;18(1):31-42. No abstract available. Abstract
  16. 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)
  17. Niebyl JR, Blake DA, Freeman JM, Luff RD. Carbamazepine levels in pregnancy and lactation. Obstet Gynecol. 1979 Abstract
  18. 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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