| Use of a sparse sampling study design to assess transfer of tramadol and its O-desmethyl metabolite into transitional breast milk. | |
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MedLine Citation:
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PMID: 18294329 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2008-02-20 |
Journal Detail:
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Title: British journal of clinical pharmacology Volume: 65 ISSN: 1365-2125 ISO Abbreviation: Br J Clin Pharmacol Publication Date: 2008 May |
Date Detail:
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Created Date: 2008-04-23 Completed Date: 2008-07-23 Revised Date: 2012-09-10 |
Medline Journal Info:
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Nlm Unique ID: 7503323 Medline TA: Br J Clin Pharmacol Country: England |
Other Details:
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Languages: eng Pagination: 661-6 Citation Subset: IM |
Affiliation:
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Pharmacology and Anaesthesiology Unit, School of Medicine and Pharmacology, University of Western Australia, Crawley, Australia. ken.ilett@uwa.edu.au |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/Analgesics, Opioid; 27203-92-5/Tramadol; 73986-53-5/O-demethyltramadol |
| Comments/Corrections | |
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