Last update Nov. 5, 2024

Fenspiride Hydrochloride

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

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)

Alternatives

  • Albuterol (Safe product and/or breastfeeding is the best option.)
  • Budesonide (Safe product and/or breastfeeding is the best option.)
  • Dextromethorphan (Safe product and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

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

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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:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 90 %
Molecular weight 297 daltons
VD 3.0 l/Kg
pKa 12.29 -
Tmax 2.3 -6 hours
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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