Article ; Online: Transfer of cetirizine/levocetirizine into human breast milk and estimation of drug exposure to infants through breastfeeding: A human lactation study from the ConcePTION project.
Basic & clinical pharmacology & toxicology
2023 Volume 134, Issue 1, Page(s) 153–164
Abstract: Data on drug transfer into human breast milk are sparse. This study aimed to quantify concentrations of cetirizine and levocetirizine in breast milk and to estimate drug exposure to infants. Breastfeeding women at least 8 weeks postpartum and using ... ...
Abstract | Data on drug transfer into human breast milk are sparse. This study aimed to quantify concentrations of cetirizine and levocetirizine in breast milk and to estimate drug exposure to infants. Breastfeeding women at least 8 weeks postpartum and using cetirizine or its pure (R)-enantiomer levocetirizine were eligible to participate. Breast milk samples were collected at six predefined times during a dose interval (0, 2, 4, 8, 12 and 24 h after drug intake) at steady state. Infant drug exposure was estimated by calculating the absolute infant dose (AID) and the weight-adjusted relative infant dose (RID). In total, 32 women were eligible for final inclusion, 31 women using cetirizine and one woman using levocetirizine. Means of the individual maximum and average cetirizine milk concentrations were 41.0 and 16.8 μg/L, respectively. Maximum concentrations occurred on average 2.4 h after intake, and the mean half-life in milk was 7.0 h. Estimated AID and RID for cetirizine in a day were 2.5 μg/kg and 1.9%, respectively. The corresponding values for levocetirizine were 1.1 μg/kg and 1.9%. No severe adverse events were reported. Our findings demonstrate that the transfer of cetirizine and levocetirizine into breast milk is low and compatible with breastfeeding. |
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MeSH term(s) | Infant ; Humans ; Female ; Cetirizine/adverse effects ; Breast Feeding ; Milk, Human ; Lactation |
Chemical Substances | levocetirizine (6U5EA9RT2O) ; Cetirizine (YO7261ME24) |
Language | English |
Publishing date | 2023-11-13 |
Publishing country | England |
Document type | Journal Article |
ZDB-ID | 2134679-3 |
ISSN | 1742-7843 ; 1742-7835 |
ISSN (online) | 1742-7843 |
ISSN | 1742-7835 |
DOI | 10.1111/bcpt.13948 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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