Document Detail

Transfer of olanzapine into breast milk, calculation of infant drug dose, and effect on breast-fed infants.
MedLine Citation:
PMID:  12900304     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: This study characterized infant drug doses and breast-milk-to-plasma area-under-the-curve ratios for olanzapine and determined plasma concentrations and effects of this drug on breast-feeding infants. METHOD: Seven mother-infant nursing pairs were studied. Olanzapine was measured in plasma and milk with high-performance liquid chromatography over a dose interval (for six patients) or at a single time after dose ingestion (for one patient) at steady state. Infant drug exposure was estimated as the product of an assumed milk production rate and average drug concentration in milk, normalized to body weight, and expressed as a percentage of maternal drug dose, normalized to body weight. RESULTS: The median infant dose of olanzapine ingested through milk was 1.02% of the maternal dose; the median milk-to-plasma area-under-the-curve ratio was 0.38 for the six patients with data collected over the dose interval. Corresponding values in the patient with single-point data were 1.13% and 0.75. Olanzapine was not detected in the plasma of the six infants with an evaluable plasma sample. All of the infants were healthy and experienced no side effects. CONCLUSIONS: Breast-fed infants were exposed to a calculated olanzapine dose of approximately 1%-well below the 10% notional level of concern. In infant plasma, olanzapine was below the detection limit; there were no adverse effects on the infants. These data support the use of olanzapine during breast-feeding. However, the authors recommend that breast-fed infants be monitored closely and the decision to breast-feed be made after individual risk-benefit analysis.
Sharon J Gardiner; Judith H Kristensen; Evan J Begg; L Peter Hackett; Debbie A Wilson; Kenneth F Ilett; Rolland Kohan; Jonathan Rampono
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The American journal of psychiatry     Volume:  160     ISSN:  0002-953X     ISO Abbreviation:  Am J Psychiatry     Publication Date:  2003 Aug 
Date Detail:
Created Date:  2003-08-05     Completed Date:  2003-09-05     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  0370512     Medline TA:  Am J Psychiatry     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1428-31     Citation Subset:  AIM; IM    
Department of Clinical Pharmacology, Christchurh Hospital, New Zealand.
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MeSH Terms
Antipsychotic Agents / analysis,  blood,  pharmacokinetics*
Area Under Curve
Breast Feeding*
Chromatography, High Pressure Liquid
Dose-Response Relationship, Drug
Milk, Human / chemistry,  metabolism*
Pirenzepine / analogs & derivatives*,  analysis,  blood,  pharmacokinetics*
Reg. No./Substance:
0/Antipsychotic Agents; 12794-10-4/Benzodiazepines; 132539-06-1/olanzapine; 28797-61-7/Pirenzepine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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