Last update: Feb. 13, 2019

Fenspiride Hydrochloride

Low Risk for breastfeeding


Moderately safe. Probably compatible.
Mild risk possible. Follow up recommended.
Read the Comment.

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).

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Fenspiride Hydrochloride is also known as


Fenspiride Hydrochloride in other languages or writings:

Tradenames

Main tradenames from several countries containing Fenspiride Hydrochloride in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 90 %
Molecular weight 297 daltons
VD 3,0 l/Kg
Tmax 2,3 -6 hours
T1/2 12 - 16 hours

References

  1. ANSM -Agence nationale de sécurité du médicament et des produits de santé. Fenspiride (Pneumorel) : Suspension des autorisations de mise sur le marché le 8 février 2019. Lettre aux professionnels de santé. 2019 Full text (link to original source) Full text (in our servers)
  2. Medana Pharma. Fenspiride. Drug Summary. 2015 Full text (link to original source) Full text (in our servers)
  3. Quartulli F, Pinelli E, Broué-Chabbert A, Gossart S, Girard V, Pipy B. Fenspiride inhibits histamine-induced responses in a lung epithelial cell line. Eur J Pharmacol. 1998 Abstract
  4. Montes B, Catalan M, Roces A, Jeanniot JP, Honorato JM. Single dose pharmacokinetics of fenspiride hydrochloride: phase I clinical trial. Eur J Clin Pharmacol. 1993 Abstract

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