Is R-4749 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use R-4749? Is R-4749 safe for nursing mother and child? Does R-4749 extracts into breast milk? Does R-4749 has any long term or short term side effects on infants? Can R-4749 influence milk supply or can R-4749 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 R-4749 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 R-4749 by patient-controlled analgesia postoperatively. On days 1 and 2 of life, the infants whose mothers received R-4749 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 R-4749 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 R-4749[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.