Last update Dec. 10, 2022

Trimebutine maleate

Low Risk

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

Antispasmodic drug with antimuscarinic and weak opioid agonist effects used for treatment of Irritable Colon Syndrome and in the treatment of infant and young child vomiting (Pediamecum 2015). Oral administration.

At latest update, no relevant published data concerning excretion into breast milk were found.

Side effects of Trimebutine are rare and generally mild. (CADTH 2015, Paquette 2014)

Authorized use in some countries during the neonatal and infant period. (Pediamecum 2015, Carnot 2008)

Although antimuscarinics can 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.

In 2017, a mother reported to us a complete decrease in milk production when taking trimebutine (time and dose not reported).

Occasional use and at a sufficient minimum dose may be compatible with breastfeeding. Monitor drowsiness and milk production. Do not use it soon after birth or in case of premature infant.

Alternatives

  • Atropine ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Linaclotide ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Otilonium Bromide (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • 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

Trimebutine maleate in other languages or writings:

Group

Trimebutine maleate belongs to this group or family:

Tradenames

Main tradenames from several countries containing Trimebutine maleate in its composition:

Pharmacokinetics

Variable Value Unit
Molecular weight 504 daltons
Protein Binding 5 %
VD 1.2 l/Kg
Tmax 1 - 2 hours
3 - 12 hours

References

  1. CADTH. Trimebutine Maleate and Pinaverium Bromide for Irritable Bowel Syndrome: A Review of the Clinical Effectiveness, Safety and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Nov 30. Abstract
  2. Comité de Medicamentos de la Asociación Española de Pediatría. Trimebutina. Pediamecum. 2015 Full text (link to original source) Full text (in our servers)
  3. Gador. Trimebutina. Ficha técnica. 2014 Full text (in our servers)
  4. Paquette JM, Rufiange M, Iovu Niculita M, Massicotte J, Lefebvre M, Colin P, Telmat A, Ranger M. Safety, tolerability and pharmacokinetics of trimebutine 3-thiocarbamoylbenzenesulfonate (GIC-1001) in a randomized phase I integrated design study: single and multiple ascending doses and effect of food in healthy volunteers. Clin Ther. 2014 Nov 1;36(11):1650-64. Abstract
  5. Aptalis Pharm. Trimebutine. Drug Summary. 2011 Full text (in our servers)
  6. Carnot. Libertrim pediátrico suspensión. Ficha técnica. 2008 Full text (in our servers)
  7. Jiang H, Ding L, Yang J, Huang X, Liu GY, Zhang ZX. [Pharmacokinetics and bioequivalence of trimebutine dispersive tablet in healthy subjects]. Yao Xue Xue Bao. 2004 Abstract
  8. 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
  9. 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

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