Last update Dec. 4, 2020

Mirabegron

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

It is a beta3-adrenergic receptor agonist, used in overactive bladder (OAB) syndrome, to treat symptoms of urgency and increased frequency of urination, as well as incontinence.
It is administered orally once a day.

Since the last update we have not found published data on its excretion in breastmilk.

Its pharmacokinetic data (EMA 2017) makes it difficult to predict transfer into breastmilk, since while the low molecular weight, the pKa and the very long half-life would facilitate transfer, the very high volume of distribution would hinder it.

On the other hand, its low bioavailability implies minimal transfer into infant plasma, except in the neonatal period and in cases of prematurity when intestinal absorption may be increased.

Until there is more published data on this drug in relation to breastfeeding, known safer alternatives during the neonatal period and in the event of prematurity may be preferable.

Alternatives

  • Oxybutynin (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Tamsulosin (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

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

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

Mirabegron in other languages or writings:

Tradenames

Main tradenames from several countries containing Mirabegron in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 29 - 35 %
Molecular weight 397 daltons
Protein Binding 71 %
VD 27.8 l/Kg
pKa 13.8 -
Tmax 3.5 hours
50 hours

References

  1. EMA. Mirabegron (Betmiga). Ficha técnica. 2017 Full text (in our servers)
  2. EMA. Mirabegron (Betmiga). Drug Summary. 2017 Full text (in our servers)

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