Document Detail

Transfer of reboxetine into breastmilk, its plasma concentrations and lack of adverse effects in the breastfed infant.
MedLine Citation:
PMID:  16699799     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To investigate the transfer of reboxetine into milk, the absolute and relative infant doses via milk and to assess plasma concentrations and adverse unwanted effects in the breastfed infant. METHODS: Multiple samples of blood and milk were obtained over a dose interval at steady-state from four women who were taking reboxetine for postnatal depression. Drug concentrations in plasma and milk were measured by high performance liquid chromatography and milk/plasma ratio (M/P), absolute infant dose and relative infant dose were estimated by standard methods. Their four, breastfed, infants were also examined clinically, and a blood sample was taken for drug analysis. RESULTS: The median (range) dose taken by the women was 6 (4-10) mg/day. There was no significant difference in reboxetine concentration between paired fore-and hind-milk samples. The mean (95% CI) M/P was 0.06 (0.03, 0.09). Absolute infant dose was 1.7 (0.7, 2.4) microg/kg/day for reboxetine while the relative infant dose was 2.0% (1.3, 2.7%). Three of the infants met normal developmental milestones and no adverse effects were seen in any infant. The fourth infant had developmental problems that were not associated with the maternal reboxetine therapy. The concentrations of reboxetine in plasma from the four infants were <4 microg/l, 2.6 microg/l, 2.3 microg/l and 5 microg/l, respectively. CONCLUSION: The study suggests that reboxetine use by lactating women is safe for the breastfed infant. Nevertheless, our study had only four mother/baby pairs, and each decision to breastfeed should always be made on the basis of an individual risk/benefit analysis.
L Peter Hackett; Kenneth F Ilett; Jonathan Rampono; Judith H Kristensen; Rolland Kohan
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't     Date:  2006-05-13
Journal Detail:
Title:  European journal of clinical pharmacology     Volume:  62     ISSN:  0031-6970     ISO Abbreviation:  Eur. J. Clin. Pharmacol.     Publication Date:  2006 Aug 
Date Detail:
Created Date:  2006-07-26     Completed Date:  2007-01-09     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  1256165     Medline TA:  Eur J Clin Pharmacol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  633-8     Citation Subset:  IM    
Clinical Pharmacology & Toxicology Laboratory, PathWest Laboratory Medicine, Nedlands, Australia.
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MeSH Terms
Antidepressive Agents / adverse effects*,  blood,  therapeutic use
Area Under Curve
Chromatography, High Pressure Liquid
Depression, Postpartum / drug therapy
Infant, Newborn
Milk, Human / chemistry*
Morpholines / adverse effects*,  blood,  therapeutic use
Reg. No./Substance:
0/Antidepressive Agents; 0/Morpholines; 98769-81-4/reboxetine

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