Product image of Motilex (Clebopride Hydrogen Maleate) supplied by GNH India

Motilex

Active Ingredient:
Clebopride Hydrogen Maleate
Origin:
EU

Motilex (Clebopride Hydrogen Maleate)

Clebopride hydrogen maleate, the active ingredient in Motilex, is a dopamine D2 receptor antagonist presented as an oral dosage form for oral use. It is employed to improve gastrointestinal motility in patients with functional dyspepsia, gastro‑oesophageal reflux disease and nausea or vomiting.

GNH India supplies Motilex as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Almirall, S.A.

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Indications & Clinical Uses

Motilex acts on dopamine D2 receptors in the gastrointestinal tract to enhance motility and aid gastric emptying.

  • Functional dyspepsia: reduces post‑prandial fullness and upper abdominal discomfort.
  • Gastro‑oesophageal reflux disease (GERD): improves lower oesophageal sphincter tone and reduces reflux episodes.
  • Nausea and vomiting: accelerates gastric emptying, helping to control acute and chronic nausea.

How It Works

  • Clebopride hydrogen maleate selectively antagonises dopamine D2 receptors located on the smooth muscle of the gastrointestinal tract. By blocking these inhibitory dopamine pathways, it increases cholinergic activity, promotes coordinated peristalsis, and accelerates gastric emptying, thereby improving overall gastrointestinal motility.

Side Effects

Motilex may be associated with a range of adverse reactions.

Common Side Effects

  • Dizziness: transient light‑headedness, especially after the first dose.
  • Dry mouth: reduced salivary flow, often mild.
  • Constipation: decreased bowel movements.
  • Headache: mild to moderate intensity.
  • Somnolence: feeling unusually sleepy.
  • Nausea: occasional upset stomach.

Serious or Rare Side Effects

  • Extrapyramidal symptoms: involuntary muscle movements or rigidity.
  • Cardiac arrhythmia: irregular heart rhythm, rarely reported.
  • Severe hypotension: marked drop in blood pressure.
  • Neuroleptic malignant syndrome: life‑threatening reaction with fever and muscle rigidity.
  • Hepatic dysfunction: elevated liver enzymes.
  • Allergic reactions: rash, pruritus, or anaphylaxis.

Precautions & Warnings

Before prescribing Motilex, clinicians should consider several safety aspects.

  • Renal or hepatic impairment: adjust monitoring as drug clearance may be reduced.
  • Bowel obstruction: avoid use in patients with known mechanical obstruction.
  • Concomitant anticholinergics: increased risk of dry mouth and constipation.
  • Elderly patients: start at lower doses and monitor for dizziness.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Motilex can interact with other medicines that affect dopamine pathways or gastrointestinal motility.

Major Interactions (Avoid)

  • Other dopamine antagonists (e.g., antipsychotics): may potentiate extrapyramidal effects.
  • Strong CYP3A4 inhibitors: can increase plasma concentrations.

Moderate Interactions (Monitor Closely)

  • Anticholinergic agents: may exacerbate dry mouth and constipation.
  • Prokinetic agents (e.g., metoclopramide): additive effects on motility could cause diarrhea.
  • Antihypertensives: monitor blood pressure for additive hypotensive effect.

Frequently Asked Questions

Motilex is prescribed to manage functional dyspepsia, gastro‑oesophageal reflux disease (GERD), and nausea or vomiting. By enhancing gastrointestinal motility, it helps relieve upper‑abdominal discomfort, reduces reflux episodes, and accelerates gastric emptying in affected patients.

Clebopride hydrogen maleate blocks dopamine D2 receptors in the gut wall. This antagonism lifts dopamine‑mediated inhibition of smooth‑muscle activity, increasing cholinergic stimulation, promoting coordinated peristalsis, and speeding up gastric emptying, which improves digestive symptoms.

The specific dose and dosing schedule of Motilex are determined by the prescribing clinician based on the patient’s condition, severity, and response to therapy. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety data for clebopride hydrogen maleate in pregnancy and lactation are limited. It should only be used if the potential therapeutic benefit justifies any possible risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.

To request Motilex, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Motilex, as a dopamine D2 antagonist, differs from agents such as metoclopramide (a dopamine‑serotonin antagonist) or erythromycin (a motilin receptor agonist). Its selective D2 blockade offers a distinct mechanism that may be preferred when other prokinetics are contraindicated or have caused intolerable side effects.

Motilex should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability.

Motilex is taken orally, usually with a glass of water. The exact timing relative to meals and the frequency of administration are determined by the prescribing clinician, who will provide detailed instructions tailored to the individual’s therapeutic needs.

Serious adverse reactions, although rare, can include extrapyramidal symptoms, severe hypotension, cardiac arrhythmias, neuroleptic malignant syndrome, and significant hepatic dysfunction. Patients should be monitored closely for any of these signs, and therapy should be discontinued if they occur.

Motilex is contraindicated in patients with known mechanical bowel obstruction, severe hepatic impairment, or a history of hypersensitivity to clebopride or any of its excipients. Caution is also advised for individuals taking other dopamine antagonists or those with uncontrolled cardiovascular disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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