Itopride Hydrochloride

Itopride tablet is indicated in gastrointestinal symptoms in chronic gastritis (feeling of an enlarged abdomen, upper abdominal pain, anorexia, heartburn, nausea and vomiting).

Itopride Hydrochloride is a potent dopamine-2 antagonist and an acetylcholine esterase inhibitor. It increases acetylcholine concentrations by inhibiting dopamine D2 receptors and acetylcholinesterase. Higher acetylcholine increases Gl peristalsis, increases the lower esophageal sphincter pressure, stimulates gastric motility, accelerates gastric emptying, and improves gastro-duodenal coordination.

The usual adult dose for oral use is 50 mg of Itopride Hydrochloride administered orally three times daily. The dose may be reduced according to the patient’s age and symptoms. Itopride Hydrochloride should be taken before meals.

Use in the elderly: Since the elderly often have a physiological hypo function, they are prone to adverse reactions and should thus be closely monitored. If adverse reactions are evident, appropriate measures such as reduction or cessation of the drug should be implemented.

Use in pediatric population: The safety and efficacy of Itopride Hydrochloride in children and adolescents have not been established. Therefore, the administration of Itopride Hydrochloride is not recommended in children and adolescents below 18 years of age.

Shock and anaphylactoid reactions: Shock and anaphylactoid reactions may occur, and close observation should be made. If hypotension, dyspnoea, larynx edema, urticaria, pallor and diaphoresis etc. occur, the drug should be discontinued and appropriate measures implemented.

Hepatic function disorder and Jaundice: Hepatic function disorder and jaundice with increased AST(GOT), ALT(GPT) and g-GTP etc., may occur, and close observation should be made. If abnormalities occur, the drug should be discontinued and appropriate therapeutic measures implemented.

The usual adult dose for oral use is 50 mg of Itopride Hydrochloride administered orally three times daily. The dose may be reduced according to the patient’s age and symptoms. Itopride Hydrochloride should be taken before meals.

Use in the elderly: Since the elderly often have a physiological hypo function, they are prone to adverse reactions and should thus be closely monitored. If adverse reactions are evident, appropriate measures such as reduction or cessation of the drug should be implemented.

Use in pediatric population: The safety and efficacy of Itopride Hydrochloride in children and adolescents have not been established. Therefore, the administration of Itopride Hydrochloride is not recommended in children and adolescents below 18 years of age.

Shock and anaphylactoid reactions: Shock and anaphylactoid reactions may occur, and close observation should be made. If hypotension, dyspnoea, larynx edema, urticaria, pallor and diaphoresis etc. occur, the drug should be discontinued and appropriate measures implemented.

Hepatic function disorder and Jaundice: Hepatic function disorder and jaundice with increased AST(GOT), ALT(GPT) and g-GTP etc., may occur, and close observation should be made. If abnormalities occur, the drug should be discontinued and appropriate therapeutic measures implemented.

Hypersensitivity to the active substance or to any of the excipients onthis preparation. This should not be used in patients in whom increased gastrointestinal motility could be harmful, e.g. in patients with gastrointestinal haemorrhage, mechanical obstruction or perforation.

Important Precautions: Itopride Hydrochloride should be used with caution since it enhances the action of acetylcholine. This drug should not be consumed continuously for an extended period when no improvement of gastrointestinal symptoms is observed.

Precautions concerning Use: When granting agent: For drugs packaged in a press-through package (PTP), instruct the patient to remove the drug from the package prior to ingestion. (It has been reported that, by accidental ingestion of the PTP sheet, the hard and sharp corners may puncture the esophageal mucosa, or even lead to perforation resulting in serious complications such as mediastinal sinusitis.)