Itopa-50 Tablet

Itopa-50 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.

Itopa-50 should be administered with care when co-administered with the following drugs:

Anticholinergic Drugs, Tiquizium bromide, Scopolamine butyl bromide, Timepidium bromide, etc.

• Sign: There is a possibility of reducing the activity of Itopa-50 which activates gastrointestinal motility (cholinergic action).
• Mechanism & risc factor: Gastrointestinal motility inhibitory action of Anticholinergic pharmacologically decreases the activity of the drug.

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.

Safety of Itopride Hydrochloride in pregnancy was not verified. Therefore itopride can be used in pregnant women or women in that pregnancy cannot be excluded only if therapeutic benefits outweigh possible risks considerably. Data about excretion in mother milk is known only in animals. Because of lack of experience with use of itopride during breast-feeding itopride it is not recommended for breast-feeding women.

Important Precautions: Itopa-50 should be used with caution since it enhances the action of acetylcholine. Itopa-50 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.)

In case of excessive overdose, the usual measures of gastric lavage and symptomatic therapy should be applied.

Osmotic purgatives

Store below 30°C, in a cool and dry place. Keep away from light. Keep all the medicine out of the reach of children.