Easyton Tablet (Itopride Hydrochloride)

Adult dose

Adults: Administer 50 mg of itopride hydrochloride orally 3 times daily before meals. Reduce the dose as appropriate according to symptoms.

This drug should not be used in patients who have had an allergic reaction to this drug or any of its components. Patients with gastrointestinal conditions where gastrointestinal motility stimulation may be harmful, such as gastrointestinal bleeding, mechanical obstruction, or perforation, should also not be administered this medication. Serious allergic reactions such as shock or anaphylaxis may occur during the use of this drug, so symptoms should be closely monitored. If symptoms such as hypotension, dyspnea, laryngeal edema, urticaria, pallor, or sweating occur, medication administration should be immediately ceased, and appropriate treatment should be sought. Liver function abnormalities or jaundice may appear, so periodic checks of liver function test results should be conducted, and if abnormalities are found, administration should be stopped. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur, so any changes in symptoms should be carefully observed. CNS symptoms such as headache, anxiety, sleep disturbances, and dizziness may also occur, so caution is advised. Endocrine abnormalities such as gynecomastia or elevated prolactin levels have been reported; if abnormal symptoms occur, discontinuation of the drug is recommended. Hematologic abnormalities such as thrombocytopenia or leukopenia may develop, so blood tests must be conducted to continuously monitor the condition. Impaired kidney function can cause elevated BUN or creatinine levels, requiring kidney function assessment. Liver enzyme elevations may also occur, necessitating monitoring of liver health. Rarely, hypersensitivity reactions such as skin rash, redness, and itching may occur, so should these symptoms appear, discontinue the drug. Extrapyramidal symptoms such as tremors may present, so immediate consultation with medical personnel is advised if any abnormal symptoms arise. Chest or back pain and fatigue may be experienced, so if these symptoms persist, informing medical personnel is advisable. This drug enhances the action of acetylcholine, so it should be used with this in mind, and long-term use should be avoided if gastrointestinal symptoms do not improve. When taken with anticholinergic agents, the efficacy of this drug may be reduced, so care must be taken to adjust dosing intervals accordingly. Safety during pregnancy has not been established; therefore, women who are pregnant or may become pregnant should use this drug only when the benefits outweigh the risks. In breastfeeding mothers, since this medication may be secreted in breast milk, it should be avoided unless absolutely necessary, and breastfeeding should be discontinued if it must be used. Safety in children has not been fully established, so caution is required when administering to children. Elderly individuals may experience adverse reactions more easily due to decreased physiological functions, so symptoms should be carefully observed, and dosage should be adjusted or administration stopped if necessary. This medication should be stored out of the reach of children, and transferring it to another container can lead to accidents and is not good for maintaining the quality of the drug.

• Shock
• anaphylaxis-like symptoms
• hypotension
• dyspnea
• laryngeal edema
• urticaria
• pallor
• sweating
• liver dysfunction
• jaundice

This drug should be stored in a tightly closed container to prevent air or moisture infiltration, and it is advisable to keep it at room temperature between 1°C and 30°C. Storing it this way helps maintain the drug's effectiveness and ensures safe use.

Appearance

White, round film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 300 tablets/bottle, For export - 30 tablets/box [(10 tablets/PTP x 3)]