Is Tramaliv Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Tramaliv? Is Tramaliv safe for nursing mother and child? Does Tramaliv extracts into breast milk? Does Tramaliv has any long term or short term side effects on infants? Can Tramaliv influence milk supply or can Tramaliv 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 Tramaliv into milk is low and even lower amounts of the active metabolite, O-desmethylTramaliv, 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 Tramaliv. Although Tramaliv is unlikely to adversely affect nursing infant,[1] the U.S. Food and Drug Administration recommends against the use of Tramaliv during breastfeeding.[2] If Tramaliv 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 Tramaliv 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 Tramaliv 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]

Tramaliv 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 Tramaliv 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 Tramaliv. Postpartum prolactin levels were higher in the Tramaliv group (348 mcg/L) than in the sufentanil group (314 mcg/L). The onset of lactation was sooner in the Tramaliv group (21.4 hours) than in the sufentanil group (25.1 hours). Both of these difference were statistically significant.[10] Note that injectable Tramaliv is not available in the United States.