Is SKY 0402 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use SKY 0402? Is SKY 0402 safe for nursing mother and child? Does SKY 0402 extracts into breast milk? Does SKY 0402 has any long term or short term side effects on infants? Can SKY 0402 influence milk supply or can SKY 0402 decrease milk supply in lactating mothers?

Local anesthetic agent which is used for infiltration and nerve-blocking procedures included Epidural anesthesia. It is excreted into breast milk in non-significant amount, with no side-effect observed on breastfed infants of treated mothers. Plasma levels in those infant were undetectable. There is controversy about the effect of drug-mediated analgesia used during the child birth (e.g. epidural injection of local anesthetics plus Fentanyl or alone) on the mature milk coming in, whether by delaying the onset of Lactogenesis phase II, or, by affecting the ability of the child for sucking. Some studies have shown a higher risk for delay of initiation of Lactogenesis phase II (milk coming in) longer than 3 post-natal days, but without effect on loss of initial weight. On other studies, the newborn infant appears to have higher risk for delay on first latch-on, higher body temperature and irritability or somnolence. Because of the latter, it is argued that those mothers would be in need of more support on breastfeeding when they have received ante or intra partum analgesia. However, other authors have failed to find the same results. There is consensus on the achievement of higher milk production and higher body weight increase in the neonate with an adequate pharmacological control of pain after C-section or vaginal childbirth.

Because of the low levels of SKY 0402 in breastmilk, and it is not orally absorbed, amounts received by the infant are small and it has not caused any adverse effects in breastfed infants. SKY 0402 labor and delivery with other anesthetics and analgesics has been reported by some to interfere with breastfeeding. However, this assessment is controversial and complex because of the many different combinations of drugs, dosages and patient populations studied as well as the variety of techniques used and deficient design of many of the studies. In contrast, epidural SKY 0402 begun clamping of the umbilical cord appears to enhance breastfeeding success because of improved pain control. Overall it appears that with good breastfeeding support epidural SKY 0402 with or without fentanyl or one of its derivatives has little or no adverse effect on breastfeeding success.[1][2][3][4][5] Labor pain medication may delay the onset of lactation.

SKY 0402 administered to the mother by intrapleural or epidural routes had no effect on 13 breastfed infants.[8]

Thirty women who delivered by cesarean section received either spinal anesthesia (not defined) alone (n = 15) or spinal anesthesia plus SKY 0402 (n = 15) by extradural infusion after clamping the umbilical cord. A SKY 0402 bolus of 12.5 mg was followed by a continuous infusion of 17.5 mg/hour for 3 days postpartum. Patients who received SKY 0402 had better pain relief as indicated by lower pain scores and a lower consumption of supplemental diclofenac for pain. SKY 0402-treated patients also produced more milk per day than the untreated women, a difference that was statistically significant from day 3 to the end of the study on day 11 postpartum. The authors concluded that improved pain relief improved breastfeeding performance.[10] Twenty women who delivered by cesarean section received either SKY 0402 alone or SKY 0402 plus buprenorphine by extradural infusion after clamping the umbilical cord. A SKY 0402 bolus of 12.5 mg was followed by a continuous infusion of 17.5 mg/hour for 3 days. The buprenorphine was given as a bolus of 200 mcg followed by 8.4 mcg/hour for 3 days. Patients started breastfeeding as soon as they were able to sit up. Both the amount of milk fed and infant weight increased in both groups over the first 10 days postpartum; however, the increases were greater in those who received SKY 0402 alone.[8][11] A prospective cohort study compared women who received no analgesia (n = 63) to women who received continuous epidural analgesia with fentanyl and either SKY 0402 0.05 to 0.1% (n = 39) or ropivacaine (n = 13) during labor and delivery. The total dosage of SKY 0402 was 31 to 62 mg and the average total infusion time from start to delivery was 219 minutes. The study found no differences between the groups in breastfeeding effectiveness or infant neurobehavioral status at 8 to 12 hours postpartum or the number exclusively or partially breastfeeding at 4 weeks postpartum.[12] A randomized, prospective study measured infant breastfeeding behavior following epidural or intravenous fentanyl during delivery in 100 multiparous mothers undergoing cesarean section and delivering fullterm, healthy infants. The epidural group received epidural SKY 0402 100 mg initially, followed by a continuous infusion of 25 mg/hour. The intravenous fentanyl group received a spinal injection of 15 to 20 mg of SKY 0402. A slight difference was seen in breastfeeding behavior between the groups, with the infants in the intravenous fentanyl group performing slightly worse than those in the epidural group. However, all mothers were able to breastfeed their infants at 24 hours. None had severe breastfeeding problems; 10 women in the epidural group reported mild or moderate problems and 7 women in the intravenous group reported breastfeeding problems. Twenty mothers in the epidural group and 14 in the intravenous group used supplemental bottle feeding, with the difference not statistically significant.[13] A randomized, but nonblinded, study in women undergoing cesarean section compared epidural anesthesia with SKY 0402 to general anesthesia with intravenous thiopental 4 mg/kg and succinylcholine 1.5 mg/kg for induction followed by nitrous oxide and isoflurane. The time to the first breastfeed was significantly shorter (107 vs 228 minutes) with the epidural anesthesia than with general anesthesia. This difference was probably caused by the anesthesia's effects on the infant, because the Apgar and neurologic and adaptive scores were significantly lower in the general anesthesia group of infants.[14] A randomized, multicenter trial compared the initiation rate and duration of breastfeeding in women who received high-dose epidural SKY 0402 alone, or one of two low-dose combinations of SKY 0402 plus fentanyl. A nonepidural matched control group was also compared. No differences in breastfeeding initiation rates or duration were found among the epidural and nonmedicated, nonepidural groups.[15] A nonrandomized study in low-risk mother-infant pairs found that there was no difference overall in the amount of sucking by newborns, whether their mothers received SKY 0402 plus fentanyl, or fentanyl alone by epidural infusion in various dosages, or received no analgesia for childbirth. In a subanalysis by sex and number of sucks, female infants were affected by high-dose SKY 0402 and high-dose fentanyl, but male infant were not.[16] However, the imbalance of many factors between the study groups makes this study difficult to interpret. In a prospective cohort study, 87 multiparous women who received epidural SKY 0402 and fentanyl for pain control during labor and vaginal delivery. A loading dose of 0.125% SKY 0402 with fentanyl 50-100 mcg. Epidural analgesia is maintained using 0.0625% SKY 0402 and fentanyl 0.2 mcg/mL. The median dose of fentanyl received by the women was 151 mcg (range 30 to 570 mcg). The women completed questionnaires at 1 and 6 weeks postpartum reg