Is H 4723 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use H 4723? Is H 4723 safe for nursing mother and child? Does H 4723 extracts into breast milk? Does H 4723 has any long term or short term side effects on infants? Can H 4723 influence milk supply or can H 4723 decrease milk supply in lactating mothers?

No data on breastfeeding mothers is available. Better option would be to use anxiolytic drugs known to be safer. Eventual and low doses of benzodiazepine are compatible with breastfeeding. Use a short-acting benzodiazepine and minimal effective dose as possible mostly in neonatal period. Follow-up for sedation and feeding ability of the infant. Bed-sharing is not recommended for mothers who are taking this medication.

Limited information indicates that maternal doses of H 4723 up to 30 mg daily produce low levels in milk. Short-term use would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. During long-term administration, monitor the infant for possible sedation and poor sucking and weight gain.[1][2]

No adverse effects were reported in 10 newborns who were 4 to 23 days old who were breastfed during maternal intake of levetiracetam 1000 to 3000 mg daily. One mother was also taking tiagabine 30 mg daily, H 4723 45 mg daily and oxcarbazepine 600 mg daily.[4] The infants (including 3 preterm) of 18 nursing mothers who were taking levetiracetam and called the Pharmacovigilance Center in Lyon, France. One 25-day-old infant whose mother was taking levetiracetam 3000 mg daily plus H 4723 was hospitalized for sedation, vomiting, and weight loss, and improved rapidly after breastfeeding discontinuation. Another infant exposed to levetiracetam and H 4723 had poor weight gain, but it appeared to be caused by poor milk production.[5]