Product image of Itopride Supremex (Itopride Hydrochloride) supplied by GNH India

Itopride Supremex

Active Ingredient:
Itopride Hydrochloride
Origin:
EU

Itopride Supremex (Itopride Hydrochloride)

Itopride, the active ingredient in Itopride Supremex, is a prokinetic agent presented as an oral tablet for oral use. It is indicated for functional dyspepsia, where it enhances gastrointestinal motility to alleviate upper‑abdominal discomfort in adult patients. The product is formulated for convenient oral administration and is marketed within the European Union.

GNH India supplies Itopride Supremex as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on quality assurance and regulatory compliance across European and global markets.

Manufacturer / TM Owner

Supremex Kft.

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Indications & Clinical Uses

Itopride acts on gastrointestinal motility disorders, particularly functional dyspepsia and its sub‑categories.

  • Functional dyspepsia: improves gastric emptying and reduces upper‑abdominal discomfort in affected patients.
  • Post‑prandial distress syndrome: alleviates early satiety and fullness after meals.
  • Epigastric pain syndrome: reduces epigastric pain associated with dyspeptic conditions.

How It Works

  • Itopride enhances gastrointestinal motility by antagonizing dopamine D2 receptors and inhibiting acetylcholinesterase, which increases acetylcholine availability in the gut. The combined dopaminergic blockade and cholinergic augmentation promote coordinated smooth‑muscle contractions, facilitating gastric emptying and intestinal transit.

Side Effects

Itopride is generally well tolerated, but adverse reactions can occur.

Common Side Effects

  • Nausea: mild to moderate feeling of sickness.
  • Diarrhea: loose stools occurring intermittently.
  • Abdominal pain: discomfort or cramps in the stomach area.
  • Headache: mild to moderate head pain.
  • Dry mouth: reduced salivation.
  • Dizziness: sensation of light‑headedness.

Serious or Rare Side Effects

  • Cardiac arrhythmia: irregular heart rhythm, potentially serious.
  • Severe allergic reaction: rash, swelling, or difficulty breathing.
  • Extrapyramidal symptoms: involuntary muscle movements.
  • Elevated liver enzymes: indication of hepatic stress.
  • Pancreatitis: inflammation of the pancreas.
  • Severe hypotension: marked drop in blood pressure.

Precautions & Warnings

Before initiating therapy, consider the following precautions.

  • Assess renal function: adjust use if renal impairment is present.
  • Monitor cardiac status: be vigilant in patients with known heart disease.
  • Use caution in elderly: increased susceptibility to side effects.
  • Avoid concomitant dopamine antagonists: may diminish therapeutic effect.
  • Discontinue if severe allergic reaction occurs: seek immediate medical attention.
  • Store at ambient temperature: keep in the original pack, protect from moisture and light.

Avoid Interactions

Itopride may interact with several medication classes.

Major Interactions (Avoid)

  • Antipsychotics (e.g., haloperidol): may reduce prokinetic efficacy.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole): can increase plasma concentrations.
  • MAO inhibitors: risk of hypertensive crisis when combined.

Moderate Interactions (Monitor Closely)

  • Anticholinergics: may diminish the drug’s prokinetic action.
  • Other prokinetic agents: additive effects could lead to excessive motility.
  • Warfarin: monitor INR for potential anticoagulation changes.

Frequently Asked Questions

Itopride Supremex is used to treat functional dyspepsia, a condition characterized by upper‑abdominal discomfort, early satiety, and post‑prandial fullness. By enhancing gastrointestinal motility, the medication helps improve gastric emptying and relieve these dyspeptic symptoms in adult patients.

Itopride works by blocking dopamine D2 receptors and inhibiting acetylcholinesterase. This dual action raises acetylcholine levels in the gut, promoting coordinated smooth‑muscle contractions that accelerate gastric emptying and improve overall intestinal transit.

The appropriate dose of Itopride Supremex is determined by the prescribing healthcare professional based on the patient’s condition, age, and overall health. Patients should follow the prescriber’s instructions and not adjust the dose without medical guidance.

Safety data for Itopride in pregnancy and lactation are limited. Healthcare providers usually weigh the potential benefits against possible risks before prescribing it to pregnant or nursing women. Patients should discuss any concerns with their doctor.

To order Itopride Supremex, 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.

Itopride differs from agents such as metoclopramide by combining dopamine antagonism with acetylcholinesterase inhibition, which may result in fewer extrapyramidal side effects. While both improve gastric motility, Itopride’s dual mechanism can offer a distinct safety and efficacy profile for functional dyspepsia.

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

Itopride Supremex is taken orally, usually as a tablet. The medication is swallowed with a glass of water, and dosing times are determined by the prescribing clinician. Patients should follow the specific instructions provided by their healthcare professional.

Serious risks, although rare, include cardiac arrhythmias, severe allergic reactions such as anaphylaxis, extrapyramidal symptoms, and significant liver enzyme elevations. Patients should seek immediate medical attention if they experience symptoms like irregular heartbeat, rash with swelling, or severe abdominal pain.

Itopride Supremex is contraindicated in individuals with known hypersensitivity to itopride or any of its excipients. Caution is advised for patients with severe cardiac disease, uncontrolled hypertension, or those taking medications that strongly interact with its metabolic pathways.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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