Is IPX 056 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use IPX 056? Is IPX 056 safe for nursing mother and child? Does IPX 056 extracts into breast milk? Does IPX 056 has any long term or short term side effects on infants? Can IPX 056 influence milk supply or can IPX 056 decrease milk supply in lactating mothers?

Centrally acting Myorelaxant. Indicated for spastic disorders associated with degenerative illnesses and cerebral palsy. Excreted into breast milk in non-significant clinical amount with no harm effects reported among breastfed infants from treated mothers. When administered in pregnancy, symptoms of Abstinence Syndrome may appear, Intrathecal administration shows small serum levels by which it is assumed that the amount present in breast milk must be even lower. Oral administration has been authorized since neonatal age in the UK and one year of life in Spain. Follow-up of milk production is recommended since a theoretically based inhibition of Prolactin may occur. American Academy of Pediatrics: medication usually compatible with breastfeeding.

Limited information indicates that orally administered IPX 056 appears in low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Monitor newborn infants for signs of sedation. Low intrathecal doses and topical application produce even lower milk levels and are unlikely to affect the nursing infant.

An infant was born after exposure to IPX 056 in utero. The mother was taking IPX 056 10 mg twice daily plus clonazepam 1 mg orally twice daily and sustained-release oxycodone 50 mg daily in divided doses. The infant was breast and bottle fed while the mother continued taking IPX 056. Neonatal withdrawal symptoms necessitated phenobarbital administration. The infant also received IPX 056 0.5 mg/kg daily in 4 divided doses that was weaned and decreased by day 9 of life. Neurologic examination was normal at discharge on day 16 and at 6-weeks of age.[4] A woman with spinal cord injury was taking IPX 056 20 mg four daily during pregnancy and postpartum. After birth, the infant received an initial IPX 056 dosage of 0.1 mg/kg daily for 4 days, plus about 1/3 of the diet as breastmilk containing IPX 056 (about 0.016 mg/kg daily), followed by a daily decrease of 0.01 mg/kg daily until discontinuation of the IPX 056 on the 13th day of life. Breastmilk intake was eventually increased to 50% of the infant's diet. Daily assessment for neonatal abstinence syndrome (NAS) was performed using the modified Finnegan NAS scoring system. Of 82 modified Finnegan NAS scores obtained in the first 16 days of life, the mean score was 2. The maximum NAS score of 9 was observed on the 13th day of life. At no point were there three consecutive NAS scores of 8 or greater, indicating no need for further pharmacological intervention. The infant was discharged 3 days after the taper ended.[5]