Trimebutine Maleate

Treatment and relief of symptoms associated with irritable bowel syndrome (spastic colon). Postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.

Trimebutine maleate is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked anti-serotonin activity especially on 'mu' receptors. It induces regulation of spontaneous activity and increases synchronization between electrophysiological spikes and contractions in isolated guinea pig strips of colon and ileum. However, it does not alter normal motility, but regulates abnormal intestinal activity.

For adults: 100 mg to 200 mg, 3 times per day before meals.

Trimebutine maleate increases the duration of d-tubocurarine-induced curarization. No other druginteractions have been observed during clinical trial or otherwise reported.

Patients with known hypersensitivity to trimebutine maleate or any excipient.

Trimebutine maleate is generally well tolerated. The infrequently reported adverse effects are as follows: dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea, constipation, drowsiness, fatigue, dizziness, hot/cold sensations, headache etc.

Although teratological studies have not shown any drug related adverse effects on the course and outcome of pregnancy, the use of trimebutine maleate in pregnant women is not recommended.

It is not known if trimebutine maleate passes into breast milk. This medication should be used while breast feeding only if the potential benefits outweigh risks to the nursing infants.

Elderly, pregnancy and lactation

No evidence of overdosage have been reported to date. However, if overdosage should occur following oral administration, gastric lavage is recommended. Treatment should be made according to the symptoms observed.

Anticholinergics.

Store in a cool and dry place, protected from light and moisture. Keep out of the reach of children.