Pharmacology
MODULON (trimebutine maleate) is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked antiserotonin activity especially on “M” 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.
Indications
For the treatment and relief of symptoms associated with the irritable bowel syndrome (spastic colon). In postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.
Precautions
Animal studies have shown that trimebutine maleate increases the duration of d-tubocurarine-induced curarization. No other drug interactions have been observed during clinical trials or otherwise reported.
Supplied
Each white, round, biconvex tablet, bisected on one side, contains: trimebutine maleate 200 mg. Nonmedicinal ingredients: lactose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and sodium starch glycolate. Bottles of 100. Store at room temperature (15 to 30°C).
Contraindications
MODULON (trimebutine maleate) is contraindicated in patients with known hypersensitivity to trimebutine or any of the excipients.
No other contraindications have been identified at this time.
Warnings
Not recommended for use in children under 12 years of age.
Although teratological studies have not shown any drug related adverse effects on the course and outcome of pregnancy in laboratory animals by both oral and parenteral routes, the use of MODULON (trimebutine maleate) in pregnant women is not recommended.
Adverse Effects
Menstrual problems, painful enlargement of breasts, anxiety, urine retention and slight deafness were also infrequently reported.
Drowsiness, fatigue, dizziness, hot/cold sensations and headaches were reported in 3.3%.
Dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea and constipation were reported in a total of 3.1% of the patient population.
rash in 0.4% of the patients.
Overdose
No evidence of overdosage have been reported to date. However, if overdosage should occur following oral administration of MODULON (trimebutine maleate), gastric lavage is recommended. Treatment should be made according to the symptoms observed.
Dosage
The adult recommended dose is up to 600 mg daily in divided doses. It is administered as one 200 mg tablet three times daily before meals.
