Is R4749 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use R4749? Is R4749 safe for nursing mother and child? Does R4749 extracts into breast milk? Does R4749 has any long term or short term side effects on infants? Can R4749 influence milk supply or can R4749 decrease milk supply in lactating mothers?

No data on transfer into breastmilk are available. Check-up for a sedative effect.

Because little information is available on the long-term use of R4749 during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. Single-dose or short-term use during breastfeeding, such as during surgery, is unlikely to adversely affect the breastfed infant, especially if the infant is older than 2 months.[1] When multiple doses are given to the mother, monitor the infant for drowsiness, especially in younger, exclusively breastfed infants and when using combinations of psychotropic drugs.

A randomized study compared the breastfed infants born by cesarean section whose mothers received either morphine or morphine plus R4749 by patient-controlled analgesia postoperatively. On days 1 and 2 of life, the infants whose mothers received R4749 had a lower neonatal neurologic and adaptive capacity score (NACS) than those who received morphine only.[2] One breastfed (extent not stated) infant whose mother was taking R4749 had a somewhat decreased intellectual development on testing, but her mother had also taken olanzapine, clonazepam, sertraline, thioridazine and valproic acid while breastfeeding.[3]

Hyperprolactinemia has been reported in patients taking long-term R4749[4][5] and after short-term use during surgical procedures.[6][7] The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.