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Estimation of rac-Amisulpride Transfer into Milk and of Infant Dose via Milk During Its Use in a Lactating Woman with Bipolar Disorder and Schizophrenia.
MedLine Citation:
PMID:  20925494     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Abstract This case describes the transfer of the antipsychotic drug amisulpride into milk and the estimation of infant exposure via breastfeeding. The dyad investigated was a 28-year-old lactating woman and her 13-month-old daughter. The woman had been taking 400 mg of amisulpride daily for 9 days and provided eight milk samples and one blood sample over a 24-hour dose interval. Amisulpride concentrations in these samples were measured by high-performance liquid chromatography, and infant dose was calculated by standard methods. The infant's health and progress were evaluated by a neonatal pediatrician. Transfer of amisulpride into milk was high, with a milk:plasma distribution ratio of 19.5 (5,188 μg/L in milk and 266 μg/L in plasma). The average amisulpride concentration in milk was 3,562 μg/L, which, when multiplied by an average milk intake of 0.15 L/kg/day, gave an absolute infant dose of 534 μg/kg/day. The relative infant dose was 10.7% of the maternal weight-adjusted dose (5,000 μg/kg/day), which is slightly above the usual 10% safety recommendation. The infant was in good health with an appropriate Denver development score for her age. She showed no acute drug-related adverse effects. Given that the infant had already benefited from 13 months of breastfeeding, that amisulpride has potential adverse effects, and that its relative infant dose was 10.7%, we recommended cessation of breastfeeding in the near-term.
Authors:
Stephanie Teoh; Kenneth F Ilett; L Peter Hackett; Rolland Kohan
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Publication Detail:
Type:  Journal Article     Date:  2010-10-06
Journal Detail:
Title:  Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine     Volume:  6     ISSN:  1556-8342     ISO Abbreviation:  Breastfeed Med     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-04-05     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101260777     Medline TA:  Breastfeed Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  85-8     Citation Subset:  IM    
Affiliation:
1 Department of Pharmacy, King Edward Memorial Hospital , Women and Newborn Health Services, Subiaco, Australia .
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