From the FDA Drug Label
USE IN SPECIFIC POPULATIONS Pediatric use:Dosage strength not appropriate for patients less than 12 years ( 2,8.4). The FDA drug label does not answer the question.
From the Research
Itopride hydrochloride is primarily used to treat gastrointestinal motility disorders, particularly functional dyspepsia and gastroesophageal reflux disease (GERD), as an add-on therapy to a proton pump inhibitor (PPI) or as a standalone treatment, with a typical dosage of 50-150 mg three times daily, taken before meals, as supported by the most recent study 1.
Uses of Itopride
The uses of itopride hydrochloride include:
- Treatment of functional dyspepsia, with a significant reduction in symptoms such as nausea, vomiting, early satiety, and abdominal pain, as shown in a study published in 2011 2
- Treatment of gastroesophageal reflux disease (GERD), with a significant improvement in symptoms such as heartburn, nausea, and laryngopharyngeal symptoms, as demonstrated in a study published in 2024 1
- Improvement of gastric emptying and reduction of reflux, through its dual action of antagonizing dopamine D2 receptors and inhibiting acetylcholinesterase, leading to increased acetylcholine levels and enhanced gastrointestinal motility, as explained in a study published in 2005 3
Dosage and Administration
The typical dosage of itopride hydrochloride for adults is 50-150 mg three times daily, taken before meals, as indicated in the studies 2, 3, 1.
Safety and Efficacy
Itopride hydrochloride is generally well-tolerated, with common side effects including mild diarrhea, headache, and abdominal pain, as reported in the studies 2, 3, 1. The most recent study 1 demonstrated the efficacy and safety of itopride as an add-on therapy to a PPI in the treatment of GERD, with a significant improvement in symptoms and no adverse effects noted.