Modulon: Indications, Dosage, Precautions, Adverse Effects
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Modulon - Product Information

Manufacture: Actavis
Country: Canada
Condition: Irritable Bowel Syndrome, Intestinal Obstruction
Class: Gastrointestinal agents
Form: Tablets
Ingredients: trimebutine maleate, lactose, microcrystalline cellulose, povidone, sodium starch glycolate, silicon dioxide, magnesium stearate

(trimebutine maleate)

Clinical Pharmacology

MODULON (trimebutine maleate) is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked anti-serotonin 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 and Clinical Use

MODULON (trimebutine maleate) is indicated:

  • for the treatment and relief of symptoms associated with the irritable bowel syndrome (spastic colon), and
  • in postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.

Contraindications

MODULON (trimebutine maleate) is contraindicated in patients with known hypersensitivity to trimebutine maleate or any of the excipients.

No other contraindications have been identified at this time.

Warnings

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.

Children

Not recommended for use in children under 12 years of age.

Precautions

Drug Interactions

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.

Adverse Reactions

In clinical studies, adverse effects of mild to moderate nature occurred in 7% of the patients treated with MODULON (trimebutine maleate). No single side effect occurred in more than 1.8% of the patients and some of these might have been related to the patient’s condition rather than the medication. The commonly reported adverse effects are as follows: a) Gastrointestinal: Dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea and constipation were reported in total of 3.1% of the patient population; b) CNS: Drowsiness, fatigue, dizziness, hot/cold sensations and headaches were reported in 3.3%; c) Allergic reactions: Rash in 0.4% of the patients; and d) Miscellaneous effects: Menstrual problems, painful enlargement of breast, anxiety, urine retention and slight deafness were also infrequently reported.

Symptoms and Treatment of Overdosage

No evidence of overdosage has 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 and Administration

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.