Last update: July 31, 2017

Zonisamide

Low Risk for breastfeeding


Moderately safe. Probably compatible.
Mild risk possible. Follow up recommended.
Read the Comment.

Zonisamide is excreted in breast milk in amounts that could be clinically significant, since the infant receives a relative dose well above 10% (Pack 2006, Crawford 2005, Tomson 2005, Shimoyama 1999, Kimura 1998).

In spite of this high excretion in breast milk, infants who were breastfed by mothers taking zonisamide had no clinical problems (Shimoyama 1999) and their plasma zonisamide levels were only 15 to 17% of those measured in the mother (Kawada 2002, abstracts-P55 2011).

Due to poor pharmacokinetics for breastfeeding with low protein binding and slow drug elimination (Jacob 2016) and the limited existing literature in relation to breastfeeding (Reimers 2014), it may be advisable to choose antiepileptics whose safety is better known (Hutchinson 2013, Davanzo 2013).

If it is administered during breastfeeding, use the minimum effective dose (Reimers 2014) and monitor the infant's appetite, weight curve, psychomotor development, irritability, diarrhea, dehydration or acidosis, and it may be desirable to measure monthly plasma levels in the infant (Davanzo 2013, Pennell 2003).

Some authors propose partial breastfeeding to decrease the dose that the infant receives through breast milk (Ando 2014).

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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

Zonisamide in other languages or writings:

Group

Zonisamide belongs to this group or family:

Tradenames

Main tradenames from several countries containing Zonisamide in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 65 - 100 %
Molecular weight 212 daltons
Protein Binding 40 - 50 %
VD 1,45 l/Kg
Tmax 2 - 5 hours
T1/2 50 - 70 hours
M/P ratio 0,4 - 1,0 -
Theoretical Dose 1,3 - 1,6 mg/Kg/d
Relative Dose 15 - 37 %
Relat.Ped.Dose 15 - 35 %

References

  1. Crettenand M, Rossetti AO, Buclin T, Winterfeld U. [Use of antiepileptic drugs during breastfeeding : What do we tell the mother?] Nervenarzt. 2018 Abstract
  2. Jacob S, Nair AB. An Updated Overview on Therapeutic Drug Monitoring of Recent Antiepileptic Drugs. Drugs R D. 2016 Abstract Full text (link to original source) Full text (in our servers)
  3. Ando H, Matsubara S, Oi A, Usui R, Suzuki M, Fujimura A. Two nursing mothers treated with zonisamide: Should breast-feeding be avoided? J Obstet Gynaecol Res. 2014 Abstract
  4. Reimers A. New antiepileptic drugs and women. Seizure. 2014 Abstract Full text (link to original source) Full text (in our servers)
  5. Hutchinson S, Marmura MJ, Calhoun A, Lucas S, Silberstein S, Peterlin BL. Use of common migraine treatments in breast-feeding women: a summary of recommendations. Headache. 2013 Abstract Full text (link to original source) Full text (in our servers)
  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. 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)
  8. 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)
  9. Hovinga CA, Pennell PB. Antiepileptic drug therapy in pregnancy II: fetal and neonatal exposure. Int Rev Neurobiol. 2008 Abstract
  10. Pack AM. Therapy insight: clinical management of pregnant women with epilepsy. Nat Clin Pract Neurol. 2006 Abstract
  11. Tomson T. Gender aspects of pharmacokinetics of new and old AEDs: pregnancy and breast-feeding. Ther Drug Monit. 2005 Abstract
  12. Crawford P. Best practice guidelines for the management of women with epilepsy. Epilepsia. 2005 Abstract Full text (link to original source) Full text (in our servers)
  13. Pennell PB. Antiepileptic drug pharmacokinetics during pregnancy and lactation. Neurology. 2003 Abstract
  14. Kawada K, Itoh S, Kusaka T, Isobe K, Ishii M. Pharmacokinetics of zonisamide in perinatal period. Brain Dev. 2002 Abstract
  15. Shimoyama R, Ohkubo T, Sugawara K. Monitoring of zonisamide in human breast milk and maternal plasma by solid-phase extraction HPLC method. Biomed Chromatogr. 1999 Abstract
  16. Kimura S. [Zonisamide:its placental transport, biological half-life in the newborn, and transport to mother's milk--a study of a case of an infant born of a mother who had been treated with zonisamide alone during pregnancy]. No To Hattatsu. 1998 Abstract

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