Modulon (Trimebutine Maleate)


Axcan Pharma

Trimebutine Maleate

Lower Gastrointestinal Tract Motility Regulator

Action And Clinical Pharmacology: Trimebutine is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has a marked antiserotonin activity especially on “mu” receptors. It induces regulation of spontaneous activity and increases synchronization between electrophysiological spikes and contractions in isolated guinea pig taenia coli and ileum. However, it does not alter normal motility, but regulates abnormal intestinal activity. tag_IndicationsIndications

Indications And Clinical Uses: 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.

Contra-Indications: Known hypersensitivity to trimebutine or any of the excipients.

In addition to the above, trimebutine injectable is contraindicated in neonates.

No other contraindications have been identified at this time.

Manufacturers’ Warnings In Clinical States: Pregnancy: 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 trimebutine in pregnant women is not recommended.

Caution should be exercised when administering trimebutine parenterally to patients under antihypertensive therapy.

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

Precautions: Drug Interactions : Animal studies have shown that trimebutine 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 trimebutine. No single side effect occurred in more than 1.8% of the patients and some of these might have been related to the patients’ conditions rather than the medication. The commonly reported adverse effects are as follows:

Oral: Gastrointestinal: Dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea and constipation were reported in a total of 3.1% of the patient population.

CNS: Drowsiness, fatigue, dizziness, hot/cold sensations and headaches were reported in 3.3%.

Allergic Reactions: Rash in 0.4% of the patients.

Miscellaneous effects: Menstrual problems, painful enlargement of breasts, anxiety, urine retention and slight deafness were also infrequently reported.

Injectable: The most frequently reported side effects were dizziness (1.8%), hypotension/vagal episode (1.0%), diarrhea (0.6%) and lightheadedness (0.5%). Isolated cases of convulsions, nausea, vomiting, malaise, lipothymic reaction, confusion, sweating, bradycardia, cramps and reaction at injection site were also reported.

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

Dosage And Administration: Tablets: The adult recommended dose is up to 600 mg daily in divided doses. It may be administered as two 100 mg tablets 3 times daily before meals or one 200 mg tablet 3 times daily before meals.

Parenteral Solution: Dosage should be individually tailored according to response, but the total parenteral daily dose should not exceed 300 mg. The usual adult dose is 50 to 100 mg 3 times daily, administered as an i.m. injection, as a 3 minute i.v. injection or as a 60 minute i.v. infusion (in dextrose 5% injection or in sodium chloride injection), until resumption of intestinal motility.

Availability And Storage: Tablets: 100 mg: Each white, round, biconvex tablet, bisected on one side and embossed “J” on the other side, contains: trimebutine maleate 100 mg. Nonmedicinal ingredients: cornstarch, gelatin, lactose spray, magnesium stearate, manitol, polyethylene glycol and sucrose. Bottles of 250. Store at room temperature.

200 mg: Each white, round, biconvex tablet, bisected on one side and embossed “J” on the other side, contains: trimebutine maleate 200 mg. Nonmedicinal ingredients: lactose, magnesium stearate, microcrystalline cellulose, polyvidone, silica gel and sodium carboxymethyl ether. Bottles of 100. Store at room temperature.

Parenteral Solution: Each 5 mL ampul contains: trimebutine maleate 50 mg. Nonmedicinal ingredients: benzyl alcohol, sodium chloride and water for injection. Boxes of 5. Store in refrigerated place (5°C). At room temperature it should be used within 48 hours. (Shown in Product Recognition Section)

MODULON® Axcan Pharma Trimebutine Maleate Lower Gastrointestinal Tract Motility Regulator

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