Itogut tablet ^®

Itogut^® is a preparation of Itopride Hydrochloride which is a potent dopamine-2 antagonist and an acetylcholinesterase inhibitor. It increases acetylcholine concentrations by inhibiting dopamine D₂ receptors and acetylcholinesterase. Higher acetylcholine increases GI peristalsis, increases the lower esophageal sphincter pressure, stimulates gastric motility, accelerates gastric emptying, and improves gastro-duodenal co-ordination.

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Itogut^® is indicated for the treatment of gastrointestinal symptoms in chronic gastritis (feeling of an enlarged abdomen, upper abdominal pain, anorexia, heartburn, nausea, and vomiting).

Route of administration: Itogut^® should be taken in oral route before a meal.
The usual adult dose is 50 mg three times daily. The dose may be reduced according to the patient's age and symptoms.

Pregnancy: Safety of itopride 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.

Lactation: Because of lack of experience with use of itopride during breastfeeding, so it is not recommended for breastfeeding women.

Use in children and adolescents
Safety and effectiveness of itopride have not been established in children and adolescents below 16 years of age.

Itopride should be used with caution since it enhances the action of acetylcholine. Itopride should not be consumed continuously for an extended period when no improvement of gastrointestinal symptoms is observed. 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. Shock and anaphylactoid reactions may occur and close observation should be made. If hypotension, dyspnea, larynx edema, urticaria, pallor, and diaphoresis etc. occur, the drug should be discontinued and appropriate measures implemented. Hepatic function disorder and jaundice with increased AST (SGOT), ALT (SGPT), 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 most common side effects are abdominal pain, diarrhea, salivary hypersecretion, dizziness, headache, etc.

It is contraindicated in patients with a history of known hypersensitivity to itopride or any other components of this product. It is also contraindicated in patients whom increased gastrointestinal motility could be harmful, e.g., in patients with gastrointestinal hemorrhage, mechanical obstruction, or perforation.

Itopride hydrochloride should be administered with care when co-administered with anticholinergic drugs, tiquizium bromide, scopolamine butyl bromide, timepidium bromide, etc.

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

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Each coated tablet contains Itopride Hydrochloride INN 50 mg.

Storage
Store below 30°C in a dry place, protected from light. Keep away from the reach of children.

Packing
Itogut^® tablet: Carton of 60 tablets in blister pack.