Is Ralivia ER Safe in Breastfeeding

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

Excretion into breast milk is non-significant. No harmful effects on breastfed infants from treated mothers have occurred. Because it is an opium-related medication, a minimal effective dose should be used together with a close follow-up of child's sedation and feeding difficulties.

The excretion of Ralivia ER into milk is low and even lower amounts of the active metabolite, O-desmethylRalivia ER, are excreted. With usual maternal dosage, the amount excreted into breastmilk is much less than the dose that has been given to newborn infants for analgesia. A study of breastfeeding in breastfed newborn infants found no adverse effects attributable to Ralivia ER. Although Ralivia ER is unlikely to adversely affect nursing infant,[1] the U.S. Food and Drug Administration recommends against the use of Ralivia ER during breastfeeding.[2] If Ralivia ER is used, monitor infants for increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties or limpness, and contact a physician immediately if any of these occur.

Seventy-five breastfed infants whose mothers were breastfeeding and taking Ralivia ER 100 mg every 6 hours following a cesarean section were compared to 75 matched infants at 2 to 4 days of age. Forty-nine percent of the mothers taking Ralivia ER and all of the control mothers were taking other opiates (primarily oxycodone) and 61% of and 58%, respectively, also were taking a nonsteroidal antiinflammatory agent (primarily diclofenac). Examination by a pediatrician revealed no difference between the groups using the Neurologic and Adaptive Capacity Score.[5]

Ralivia ER can increase serum prolactin.[8] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed. A randomized study compared Ralivia ER and naproxen for post-cesarean section pain. Patients received the drugs either on a fixed schedule or as needed. No difference in breastfeeding rates were seen among the groups.[9] In a study in China, women with a scheduled cesarean section were randomized to receive intravenous patient-controlled analgesia with either sufentanil or Ralivia ER. Postpartum prolactin levels were higher in the Ralivia ER group (348 mcg/L) than in the sufentanil group (314 mcg/L). The onset of lactation was sooner in the Ralivia ER group (21.4 hours) than in the sufentanil group (25.1 hours). Both of these difference were statistically significant.[10] Note that injectable Ralivia ER is not available in the United States.