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Oxazolidonic compound with antihistaminic, anti-inflammatory and bronchodilator actions not well studied. Indicated in the symptomatic treatment of cough and expectoration of bronchial and lung inflammatory diseases. (Medana 2015, Quartulli 1998)
At the date of last update we did not find published data on its excretion in breast milk.
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, make it likely to pass into milk in an amount that could be significant and that could reach the infant's plasma (high oral bioavailability).
Its possible adverse effects are mild and not very frequent. (Medana 2015)
Authorized pediatric use from two years of age. Product little studied in humans, with very few bibliographic references and marketed in very few countries.
Until more published data on this drug in relation to breastfeeding are known, 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 of Fenspiride because of the risk of QT prolongation. (ANSM 2019)