Is Trimebutine maleate compatible with breastfeeding? Do we have alternatives for Trimebutine maleate?

Trimebutine maleate

January 4, 2015 (Low Risk)

Antispasmodic drug used for treatment of Irritable Colon Syndrome.

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

Pharmacokinetic data support the likelihood of significant excretion into breast milk, despite of the excretion in the milk of animals has shown to be poor (less than 0.1%).

Side effects of Trimebutine are rare and generally mild.

This medication is not authorized for children under 12 years old. However, it has been used in neonates and infants in some countries.

Anticholinergic drugs may reduce milk production. Use the minimal necessary dose as possible and avoid long-term use whenever a decrease in milk production would appear. Do not use it soon after birth or in case of premature infant.

Alternatives

We do not have alternatives for Trimebutine maleate.

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

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

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Synonyms

  • Тримебутина Малеат
  • トリメブチンマレイン酸塩

References

  1. 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. 2014Abstract
  2. Trimebutina. Ficha técnica. 2014 Full text (in our servers)
  3. Trimebutine. Drug Summary. 2011 Full text (in our servers)
  4. Trimebutina. Ficha técnica. 2008 Full text (in our servers)
  5. Laboratorios Carnot. Libertrim pediátrico suspensión. Ficha técnica. 2008 Full text (in our servers)
  6. 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. 2004Abstract
  7. Trimebutina. Ficha técnica. 2001 Full text (in our servers)