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  • Suboxone

    Is there more current information/studies on breastfeeding newborns whose mothers are prescribed Suboxone than in the 2010 MMM? Any information would be appreciated.

  • #2

    This is all the data we have.

    Tom Hale


    In one patient who received 4 mg/day buprenorphine to facilitate withdrawal from other opiates, the amount of buprenorphine transferred via milk was only 3.28 µg/day, an amount that was clinically insignificant.[3] No symptoms were noted in this breastfed infant. In another study of continuous epidural bupivacaine and buprenorphine in post cesarean women for 3 days[4], it was suggested that buprenorphine may suppress the production of milk (and infant weight gain) although this was not absolutely clear. In another study of one patient on buprenorphine maintenance for 7 months, and who received 8 mg daily sublingually over 4 days, milk levels of buprenorphine and norbuprenorphine ranged from 1.0 to 14.7 ng/mL and 0.6 to 6.3 ng/mL, respectively.[5] Plasma concentrations of both analytes ranged from 0.2 to 20.1 ng/mL (buprenorphine) and 1.2 to 4.4 ng/mL (norbuprenorphine) over 4 days of study. Using peak levels only, the concentration of buprenorphine and norbuprenorphine were 1.47 and 0.63 µg/100 mL of breast milk, respectively. Assuming an intake of 150 mL/kg/day, the authors estimated the daily dose would be less than 10 µg for a 4 kg infant, a dose that is probably far subclinical. In a recent study of 7 women[6] who were taking a median of 0.32 mg/kg/day buprenorphine, the median area under the curve estimates of milk levels were 0.12 mg.h/L for buprenorphine and 0.10 mg.h/L for norbuprenorphine. Levels of buprenorphine and norbuprenorphine in the infant plasma were approximately 4.5% and 11.7% of maternal levels. Based on these studies it can be concluded that although experience with the use of buprenorphine in breastfeeding women is limited, there is no evidence that the use of this drug will have an adverse effect in the breastfed infant. The relative infant dose of buprenorphine is 0.09-1.9%.

    Naloxone is commonly used for the treatment of opiate overdose, and now to prevent opiate abuse in patients undergoing withdrawal treatment. Naloxone is poorly absorbed orally and plasma levels in adults are undetectable (<0.05ng/mL) two hours after oral doses. Following intravenous use (0.4 mg), plasma naloxone levels averaged <0.084 &#181;g/mL. Side effects are minimal except in narcotic-addicted patients. The AAP has advised that naloxone should not be administered (directly) to infants of narcotic-dependent mothers. Its use in breastfeeding mothers would be unlikely to cause problems as its milk levels would likely be low and its oral absorption is minimal to nil.

    In summary, it is unlikely that the breastmilk levels of buprenorphine and noloxone will be significant. It can therefore be stated that the use of buprenorphine + naloxone combination is probably safe during breastfeeding.


    • #3

      Subutex (Buprenorphine) & Suboxone (Buprenorphine & Narcan)
      Any upper limit for not breastfeeding?
      Have had experiences of moms being decreased before delivery to help with withdrawl of neonate then go back up to usual doseage. Why increase again? Thanks so much.


      • #4

        Upper limits depend on two things. One, just how high is the dose, and two, is the infant already tolerant of the dose, say following 3 months or more of gestation.

        I suggest, that if an infant has been exposed extensively during pregnancy, they are already tolerant of high doses, and are at less risk of high maternal/breastfeeding doses. That said, if a mom swings repeatedly between high and low doses, then the infant is a great risk.

        So moms on high doses of these drugs should increase their dose gently, or decrease gently over a long period of time, and not bounce back and forth between 100 mg one day, and 250 mg the next day. Consistency is important to prevent overdosing the infant.

        We know from years of experience with methadone, that infants can become quite tolerant of extraordinary high doses of this opioid, and they can do just fine.

        I would assume the same for Subutex, but we don't really have much data on this is breastfed infants.

        I'd just recommend, that if you use higher doses, remember the infant will become quite tolerant and dependent on these doses. Also, in these infants, other opioids would become nonfunctional, if they were needed for analgesia such as following a painful procedure or surgery.

        Tom Hale Ph.d.


        • #5
          Dr. Hale,
          When you refer above to daily dose of 100mg-250mg that is Methadone and not Subutex or Suboxone, correct? I have heard of doses up to 32mg with Subutex or Suboxone. (Still trying to garner more information about this medication as it is becoming more widely used in the population.) Thank you


          • #6

            Yes, I was referring to methadone, not subutex.