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An oxazolidinone compound with antihistamine, anti-inflammatory and bronchodilatory actions which have not been thoroughly studied.
Indicated in the symptomatic treatment of coughing and expectoration caused by inflammatory bronchial and lung diseases (Medana 2015, Quartulli 1998).
Since the last update we have not found published data on its excretion in breastmilk.
In the absence of knowing the percentage of plasma protein binding, its known pharmacokinetic data (Medana 2015, Montes 1993) (low molecular weight, half-life of more than 12 hours) makes it likely it will transfer to milk in amounts that could be significant and that could reach infant plasma (high oral bioavailability).
Its possible adverse effects are mild and not very frequent (Medana 2015).
Authorized pediatric use from two years of age.
This product has been little studied in humans, with very few bibliographical references and is sold in very few countries.
Until there is more published data on this drug in relation to breastfeeding, safer known alternatives may be preferable, especially during the neonatal period and in case of prematurity.
In 2019, the National Agency (France) for Drug Safety suspended the marketing authorization for Fenspiride due to the risk of QT prolongation (ANSM 2019).