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It is a benzoxazine with an anxiolytic effect (Vicente 2020, Sartori 2019, Stein 2015, Nguyen 2006).
Oral administration in two to three daily doses.
At the date of the last update we did not find any published data on its excretion in breast milk.
Its high plasma protein binding (Nuss 2019) make it unlikely its excretion into breast milk in significant amounts.
Product with very few bibliographic references and marketed in few countries. Drug not approved by the FDA or the EMA (Sartori 2019); pending review of the risk / benefit ratio of this medicine (EMA 2021, Malta 2021).
It produces temporary drowsiness. Serious skin reactions, liver and intestinal toxicity, and menstrual disturbances have been reported (EMA 2021, Malta 2021, Sartori 2019, Cottin 2016, Moch 2012, Mennecier 2003).
Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable, especially during the neonatal period and in the event of prematurity.
Somnolence and adequate feeding of the infant should be monitored.
Bed-sharing with the baby is not recommended if drugs are used due to increased risk of suffocation or sudden infant death (ABM 2019, UNICEF 2020 & 2008, 2017, 2014 & 2013, Landa 2012, ABM 2008, UNICEF 2006).