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

Itoprom

Active Ingredient:
Itopride Hydrochloride
Origin:
EU

Itoprom (Itopride Hydrochloride)

Itopride Hydrochloride, the active ingredient in Itoprom, is a prokinetic agent presented as an oral dosage form for oral administration. It is indicated for functional gastrointestinal disorders, including functional dyspepsia, gastric motility disorders, and gastroesophageal reflux disease, primarily in adult patients. The product complies with EU regulatory standards and is available for export to multiple markets. It is manufactured under GMP conditions and undergoes rigorous quality testing before distribution.

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

Manufacturer / TM Owner

Pro.Med.Cs Praha A.S.

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Indications & Clinical Uses

Itopride Hydrochloride is a prokinetic agent used to improve gastrointestinal motility in functional gastrointestinal disorders.

  • Functional dyspepsia: alleviates upper abdominal discomfort and early satiety by enhancing gastric emptying.
  • Gastric motility disorders: improves gastric emptying and reduces stasis in conditions such as gastroparesis.
  • Gastroesophageal reflux disease: reduces reflux episodes by promoting coordinated esophageal clearance.

How It Works

  • Itopride Hydrochloride exerts its prokinetic effect by antagonizing dopamine D2 receptors in the gastrointestinal tract and inhibiting acetylcholinesterase. The D2 antagonism removes inhibitory dopaminergic tone, while acetylcholinesterase inhibition increases acetylcholine availability, together enhancing cholinergic stimulation of smooth‑muscle contractility and accelerating gastric emptying and intestinal transit. These actions collectively improve coordinated motility of the stomach and upper intestine, facilitating digestion and reducing symptoms associated with delayed gastric emptying.

Side Effects

Adverse reactions to Itopride Hydrochloride are generally mild but may vary among individuals.

Common Side Effects

  • Nausea: mild transient feeling of queasiness.
  • Diarrhea: loose stools occurring intermittently.
  • Abdominal pain: cramp-like discomfort in the stomach area.
  • Headache: mild to moderate head pain.
  • Dizziness: sensation of light‑headedness or unsteadiness.
  • Dry mouth: reduced salivation causing throat dryness.
  • Fatigue: feeling of tiredness or lack of energy.

Serious or Rare Side Effects

  • Extrapyramidal symptoms: involuntary muscle movements or rigidity.
  • Allergic reactions: rash, itching, or swelling indicating hypersensitivity.
  • Hepatotoxicity: signs of liver injury such as jaundice.
  • Cardiac arrhythmia: irregular heart rhythm reported rarely.
  • Severe hypotension: marked drop in blood pressure.
  • Pancreatitis: inflammation of the pancreas presenting with abdominal pain.
  • Seizures: rare occurrence of convulsive episodes.

Precautions & Warnings

When prescribing Itopride Hydrochloride, clinicians should consider several precautionary measures to ensure safe use.

  • Pregnancy: use only if potential benefit justifies the risk, as safety data are limited.
  • Breastfeeding: assess risk versus benefit because excretion in milk is not well established.
  • Renal impairment: adjust therapy or monitor closely in patients with reduced kidney function.
  • Hepatic impairment: use with caution in patients with liver disease.
  • Drug interactions: review concomitant medications that may affect dopamine or acetylcholine pathways.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and light in the original packaging.

Avoid Interactions

Itopride Hydrochloride may interact with other medicines that influence dopaminergic or cholinergic activity, as well as drugs affecting gastrointestinal motility.

Major Interactions (Avoid)

  • Antipsychotics (e.g., haloperidol): may counteract prokinetic effect.
  • Anticholinergic agents (e.g., atropine): may diminish efficacy.
  • CYP450 inhibitors (e.g., ketoconazole): potential increase in plasma levels.

Moderate Interactions (Monitor Closely)

  • Metoclopramide: additive prokinetic action may increase risk of extrapyramidal symptoms.
  • MAO inhibitors: possible enhanced dopaminergic effects.
  • Proton pump inhibitors: may alter gastric pH influencing drug absorption.

Frequently Asked Questions

Itoprom contains Itopride Hydrochloride, a prokinetic medication indicated for functional dyspepsia, gastric motility disorders such as gastroparesis, and gastroesophageal reflux disease. It works by enhancing gastrointestinal motility, thereby relieving symptoms like upper abdominal discomfort, delayed gastric emptying, and reflux episodes.

Itopride Hydrochloride acts by blocking dopamine D2 receptors in the gut and inhibiting the enzyme acetylcholinesterase. This dual action removes dopamine‑mediated inhibition and raises acetylcholine levels, which together stimulate smooth‑muscle contraction and accelerate gastric emptying and intestinal transit.

The dosage of Itoprom is individualized by the prescribing healthcare professional based on the patient’s condition, age, and response to therapy. Physicians determine the appropriate strength, frequency, and duration of treatment in accordance with clinical guidelines and local prescribing information.

Safety data for Itopride Hydrochloride in pregnancy are limited, so it should only be used when the potential benefit outweighs any possible risk to the fetus. Likewise, because excretion in breast milk is not well defined, use while breastfeeding requires a careful risk‑benefit assessment by the prescriber.

To request Itoprom, 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 (including any cold‑chain requirements), and the necessary import documentation.

Itoprom (Itopride) differs from agents such as metoclopramide by combining dopamine D2 antagonism with acetylcholinesterase inhibition, which may result in a lower incidence of central nervous system side effects. While metoclopramide is a pure dopamine antagonist, Itopride’s additional cholinergic activity can provide a broader enhancement of gastrointestinal motility.

Itoprom should be stored at ambient temperature, preferably below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid storing it in areas with high humidity or direct sunlight.

Itoprom is taken orally, usually with a glass of water. The tablet can be taken with or without food, unless the prescribing physician advises otherwise. Patients should follow the dosing schedule provided by their healthcare professional and not alter the regimen without medical guidance.

Serious adverse events, although rare, include extrapyramidal symptoms such as muscle rigidity or involuntary movements, severe allergic reactions (rash, swelling, anaphylaxis), hepatotoxicity indicated by jaundice, cardiac arrhythmias, and marked hypotension. Patients should seek immediate medical attention if any of these symptoms develop.

Itoprom is contraindicated in individuals with known hypersensitivity to itopride or any excipients in the formulation. Caution is advised for patients with severe hepatic or renal impairment, uncontrolled cardiac disease, or those taking medications that strongly antagonize its prokinetic action, such as certain antipsychotics or anticholinergics.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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