Generic Name
Trimebutine MaleateTherapeutic Class: Gastro-Intestinal Disorders
Indications: 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.
Presentation:
Trimebutine Maleate Tablet: Each film-coated tablet contains Trimebutine Maleate INN 100 mg.
Description:
Trimebutine Maleate is a noncompetitive spasmolytic agent & lower gastrointestinal tract regulator. 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 strips of colon and ileum. However, it does not alter normal motility but regulates abnormal intestinal activity.
Dosage & Administration:
For adults: 100-200 mg (1-2 tablets), 3 times per day before meals.
Use in children: Trimebutine is not recommended for use in children under 12 years of age.
Side Effects:
Trimebutine Maleate is generally well tolerated. The infrequently reported adverse effects are as follows: a) Gastrointestinal: Dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea, constipation, b) CNS: Drowsiness, fatigue, dizziness, hot/cold sensations, headache, etc.
Use in Pregnancy & Lactation:
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 whether Trimebutine Maleate passes into breast milk or not. This medication should be used while breastfeeding only if the potential benefits outweigh the risks to the nursing infants.
Interaction:
Trimebutine maleate increases the duration of d-tubocurarine-induced curarization. No other drug interactions have been observed during clinical trials or otherwise reported.
Overdose:
No evidence of overdosage has been reported to date. However, if overdosage should occur following oral administration of Trimebutine Maleate, gastric lavage is recommended. Treatment should be made according to the symptoms observed.
Storage:
Store in a cool and dry place, protected from light and moisture. Keep out of the reach of children.