Document Detail


Use of a sparse sampling study design to assess transfer of tramadol and its O-desmethyl metabolite into transitional breast milk.
MedLine Citation:
PMID:  18294329     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: There are presently no published data on tramadol transfer into breast milk or on its effects in the breastfed infant.
WHAT THIS STUDY ADDS: We have provided quantitative data on the absolute and relative infant doses of rac-tramadol and it rac-O-desmethyl metabolite for the breastfed infant. We have also demonstrated a novel sparse sampling data collection method for investigating infant exposure via milk.
AIMS: To investigate the transfer of rac-tramadol and its rac-O-desmethyl metabolite into transitional milk, and assess unwanted effects in the breastfed infant.
METHODS: Tramadol HCl (100 mg six hourly) was administered to 75 breastfeeding mothers for postoperative analgesia on days 2-4 after Caesarian section. Milk and plasma samples were collected after administration of four or more doses. Rac-tramadol and rac-O-desmethyltramadol were measured by high performance liquid chromatography. Milk : plasma ratio (M : P) and infant doses were calculated by standard methods. The behavioural characteristics of the exposed breastfed infants and a matched control group of infants not exposed to tramadol were also studied. RESULTS At steady-state, mean (95% CI) M : P was 2.2 (2.0, 2.4) for rac-tramadol and 2.8 (2.5, 3.1) for rac-O-desmethyltramadol. The estimated absolute and relative infant doses were 112 (102, 122) microg kg(-1) day(-1) and 30 (28, 32) microg kg(-1) day(-1), and 2.24% (2.04, 2.44)% and 0.64% (0.59, 0.69)% for rac-tramadol and rac-O-desmethyltramadol, respectively. The exposed infants and control breastfed infants had similar characteristics, including Apgar scores at birth and Neurologic and Adaptive Capacity Scores.
CONCLUSIONS: The combined relative infant dose of 2.88% at steady-state was low. The similarity of NACS in exposed infants and controls suggests that there were no significant behavioural adverse effects. We conclude that short-term maternal use of tramadol during establishment of lactation is compatible with breastfeeding.
Authors:
Kenneth F Ilett; Michael J Paech; Madhu Page-Sharp; Sherwin K Sy; Judith H Kristensen; Raymond Goy; Sebastian Chua; Tracey Christmas; Karen L Scott
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2008-02-20
Journal Detail:
Title:  British journal of clinical pharmacology     Volume:  65     ISSN:  1365-2125     ISO Abbreviation:  Br J Clin Pharmacol     Publication Date:  2008 May 
Date Detail:
Created Date:  2008-04-23     Completed Date:  2008-07-23     Revised Date:  2012-09-10    
Medline Journal Info:
Nlm Unique ID:  7503323     Medline TA:  Br J Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  661-6     Citation Subset:  IM    
Affiliation:
Pharmacology and Anaesthesiology Unit, School of Medicine and Pharmacology, University of Western Australia, Crawley, Australia. ken.ilett@uwa.edu.au
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MeSH Terms
Descriptor/Qualifier:
Adult
Analgesics, Opioid / pharmacokinetics*
Breast Feeding*
Case-Control Studies
Chromatography, High Pressure Liquid
Female
Humans
Infant, Newborn
Milk, Human / metabolism*
Pregnancy
Tramadol / analogs & derivatives*,  metabolism,  pharmacokinetics*
Chemical
Reg. No./Substance:
0/Analgesics, Opioid; 27203-92-5/Tramadol; 73986-53-5/O-demethyltramadol
Comments/Corrections

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