Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment

Objective: The aim of the present study was to estimate the dose of buprenorphine and its primary metabolite norbuprenorphine that a breastfed infant would receive during maternal maintenance treatment with buprenorphine. Study Design: Seven pregnant opioid-dependent women taking buprenorphine (medi...

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Main Authors: Ilett, K., Hackett, L., Gower, Shelley, Doherty, D., Hamilton, D., Bartu, Anne
Format: Journal Article
Published: Mary Ann Liebert, Inc. Publishers 2012
Online Access:http://hdl.handle.net/20.500.11937/6542
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author Ilett, K.
Hackett, L.
Gower, Shelley
Doherty, D.
Hamilton, D.
Bartu, Anne
author_facet Ilett, K.
Hackett, L.
Gower, Shelley
Doherty, D.
Hamilton, D.
Bartu, Anne
author_sort Ilett, K.
building Curtin Institutional Repository
collection Online Access
description Objective: The aim of the present study was to estimate the dose of buprenorphine and its primary metabolite norbuprenorphine that a breastfed infant would receive during maternal maintenance treatment with buprenorphine. Study Design: Seven pregnant opioid-dependent women taking buprenorphine (median, 7mg/day; range, 2.4–24 mg) and who intended to breastfeed were recruited. After lactation was established, several milk samples were collected from each subject over a 24-hour dose interval, and buprenorphine and norbuprenorphine concentrations were measured by liquid chromatography–tandem mass spectrometry. The average concentration (Cavg) across the dose interval was estimated as for both buprenorphine and norbuprenorphine (as buprenorphine equivalents). Absolute infant dose (AID), defined as Cavg daily milk intake, and relative infant dose (RID), defined as 100 AID/weight-adjusted maternal daily dose, via milk were calculated, assuming a milk intake of 0.15 L/kg/day. The infant’s health and progress were assessed directly and by questionnaire on the study day. Results: Mean (95% confidence interval) norbuprenorphine concentration in milk and AID values (1.94 [0.79–3.08] μg/L and 0.29 [0.12–0.46] μg/kg/day, respectively) were approximately half those for buprenorphine (3.65[1.61–5.7] μg/L and 0.55 [0.24–0.85] μg/kg/day, respectively). Similarly, the mean RID values were 0.18% (0.11–0.25%) for norbuprenorphine and 0.38% (0.23–0.53%) for buprenorphine. The breastfed infants showed no adverse effects, were all in good health, and were progressing as expected. Conclusion: Thus the dose of buprenorphine and norbuprenorphine received via milk is unlikely to cause any acute adverse effects in the breastfed infant.
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spelling curtin-20.500.11937-65422017-09-13T15:54:29Z Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment Ilett, K. Hackett, L. Gower, Shelley Doherty, D. Hamilton, D. Bartu, Anne Objective: The aim of the present study was to estimate the dose of buprenorphine and its primary metabolite norbuprenorphine that a breastfed infant would receive during maternal maintenance treatment with buprenorphine. Study Design: Seven pregnant opioid-dependent women taking buprenorphine (median, 7mg/day; range, 2.4–24 mg) and who intended to breastfeed were recruited. After lactation was established, several milk samples were collected from each subject over a 24-hour dose interval, and buprenorphine and norbuprenorphine concentrations were measured by liquid chromatography–tandem mass spectrometry. The average concentration (Cavg) across the dose interval was estimated as for both buprenorphine and norbuprenorphine (as buprenorphine equivalents). Absolute infant dose (AID), defined as Cavg daily milk intake, and relative infant dose (RID), defined as 100 AID/weight-adjusted maternal daily dose, via milk were calculated, assuming a milk intake of 0.15 L/kg/day. The infant’s health and progress were assessed directly and by questionnaire on the study day. Results: Mean (95% confidence interval) norbuprenorphine concentration in milk and AID values (1.94 [0.79–3.08] μg/L and 0.29 [0.12–0.46] μg/kg/day, respectively) were approximately half those for buprenorphine (3.65[1.61–5.7] μg/L and 0.55 [0.24–0.85] μg/kg/day, respectively). Similarly, the mean RID values were 0.18% (0.11–0.25%) for norbuprenorphine and 0.38% (0.23–0.53%) for buprenorphine. The breastfed infants showed no adverse effects, were all in good health, and were progressing as expected. Conclusion: Thus the dose of buprenorphine and norbuprenorphine received via milk is unlikely to cause any acute adverse effects in the breastfed infant. 2012 Journal Article http://hdl.handle.net/20.500.11937/6542 10.1089/bfm.2011.0096 Mary Ann Liebert, Inc. Publishers fulltext
spellingShingle Ilett, K.
Hackett, L.
Gower, Shelley
Doherty, D.
Hamilton, D.
Bartu, Anne
Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment
title Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment
title_full Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment
title_fullStr Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment
title_full_unstemmed Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment
title_short Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment
title_sort estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment
url http://hdl.handle.net/20.500.11937/6542