Last update Dec. 10, 2022

Otilonium Bromide

Low Risk

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

Anticholinergic drug used as spasmolytic for functional gastrointestinal disorders.

At latest update relevant published data on excretion into breast milk were not found.

It acts locally on the intestinal mucosa. Absorption through the intestine is practically absent (Evangelista 2004, Catalogo 2008), with an excretion being almost 100% unmodified in feces that is determinant for the extremely low levels reached in the plasma: <0.02 mg / L (Zhao 2010), which causes the passage through breastmilk in significant amounts must be very unlikely.

Its very low oral bioavailability minimizes the passage into plasma of the infant from ingested breast milk, except in the premature and in the immediate neonatal period in which there may be greater intestinal permeability.

Although antimuscarinics are thought to decrease prolactin production (Müller 1983, Masala 1982), once lactation is established, milk production depends more on the repeated stimulation of suckling than on prolactin levels.

Side effects are mild and very rarely seen. 

The literature on this drug is scarce and it is sold in few countries.


  • Atropine ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Linaclotide ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Rifaximin ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

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

Otilonium Bromide in other languages or writings:


Otilonium Bromide belongs to this group or family:


Main tradenames from several countries containing Otilonium Bromide in its composition:


Variable Value Unit
Oral Bioavail. 3 %
Molecular weight 564 daltons
Tmax 1.5 hours


  1. AEMPS. Otilonio. Ficha técnica. 2015 Full text (in our servers)
  2. Zhao YR, Ding L, Fan HW, Yu Y, Qi XM, Leng Y, Rao YK. Determination of the unstable drug otilonium bromide in human plasma by LC-ESI-MS and its application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2010 Abstract
  3. Catalioto RM, Triolo A, Giuliani S, Altamura M, Evangelista S, Maggi CA. Increased paracellular absorption by bile salts and P-glycoprotein stimulated efflux of otilonium bromide in Caco-2 cells monolayers as a model of intestinal barrier. J Pharm Sci. 2008 Abstract
  4. Evangelista S. Quaternary ammonium derivatives as spasmolytics for irritable bowel syndrome. Curr Pharm Des. 2004 Abstract
  5. Müller EE, Locatelli V, Cella S, Peñalva A, Novelli A, Cocchi D. Prolactin-lowering and -releasing drugs. Mechanisms of action and therapeutic applications. Drugs. 1983 Apr;25(4):399-432. Review. Abstract
  6. Masala A, Alagna S, Devilla L, Rovasio PP, Rassa S, Faedda R, Satta A. Muscarinic receptor blockade by pirenzepine: effect on prolactin secretion in man. J Endocrinol Invest. 1982 Jan-Feb;5(1):53-5. Abstract

Total visits


Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at

e-lactancia is a resource recommended by El Parto Es Nuestro of Spain

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM