Trimotil

• Approved Indications:
• Treatment of functional gastrointestinal disorders (FGIDs) including irritable bowel syndrome (IBS) characterized by abdominal pain and altered bowel habits.
• Relief of symptoms associated with gastrointestinal motility disorders, such as abdominal cramps, bloating, and irregular bowel movements.
• Management of postoperative ileus to improve gastrointestinal motility.
• Off-label Uses:
• Adjunctive therapy for functional dyspepsia.
• Symptomatic relief in other non-ulcer dyspepsia and motility-related gastrointestinal complaints.

• Adults:
• Typical oral dose: 100 mg to 200 mg three times daily, before meals.
• Dosage may be adjusted according to symptom severity and clinical response.
• Pediatrics:
• Safety and efficacy not well established; use with caution and under specialist guidance.
• Elderly:
• No specific dose adjustment recommended; start at lower dose if needed, monitor for tolerability.
• Special Populations:
• Limited data on renal or hepatic impairment; use cautiously in severe dysfunction.
• Administration Route:
• Oral tablets or capsules, taken preferably before meals.

Trimebutine maleate acts as a modulator of gastrointestinal motility by exerting a spasmolytic effect through peripheral opioid receptor agonism (primarily µ, δ, and κ receptors) in the gut. It normalizes abnormal gastrointestinal motility by either stimulating or inhibiting smooth muscle contractions depending on the existing motility state, thereby relieving spasms and regulating bowel movements. Additionally, it has mild analgesic properties by modulating visceral sensory pathways.

• Absorption: Well absorbed orally with moderate bioavailability; peak plasma levels reached within 1 to 2 hours.
• Distribution: Widely distributed in body tissues, including the gastrointestinal tract.
• Metabolism: Extensively metabolized in the liver mainly by demethylation and conjugation.
• Elimination: Primarily excreted via the urine as metabolites.
• Half-life: Approximately 2 to 4 hours.
• Onset of Action: Symptom relief typically occurs within hours to days of initiation.

• Pregnancy:
• FDA pregnancy category not assigned; limited human data. Use only if benefits justify potential risks.
• Lactation:
• Unknown if excreted in human milk; caution advised. Breastfeeding not recommended during treatment unless clearly necessary.

• Primary Class: Gastrointestinal motility modulator
• Subclass: Peripheral opioid receptor agonist with spasmolytic effects

• Known hypersensitivity to trimebutine or any formulation excipients.
• Mechanical gastrointestinal obstruction.
• Severe hepatic or renal impairment (relative contraindication; use cautiously).
• Paralytic ileus.

• Use with caution in patients with severe hepatic or renal dysfunction.
• Monitor for signs of intestinal obstruction or worsening abdominal symptoms.
• Not recommended for use in patients with known opioid hypersensitivity.
• Use cautiously in elderly patients due to possible altered pharmacodynamics.
• Avoid abrupt discontinuation if long-term therapy is used.

• Common:
• Nausea, dry mouth, dizziness, fatigue.
• Mild abdominal discomfort or bloating.
• Less Common/Rare:
• Allergic reactions such as rash or pruritus.
• Headache, mild sedation.
• Side effects are usually mild and transient.

• No significant CYP450 enzyme interactions reported.
• Potential additive CNS depressant effects if used with sedatives or alcohol.
• Use caution when combined with other gastrointestinal motility agents.

• Continued use recommended as a symptomatic treatment for IBS and FGIDs in recent clinical guidelines.
• No major changes in dosing or safety warnings noted in recent regulatory updates.
• Ongoing studies evaluating broader applications in functional gastrointestinal disorders.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep in a tightly closed container.
• Do not freeze.
• Keep out of reach of children.