Yubatone Tablets (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 medication should not be used by patients who are allergic to this drug or any of its ingredients or have had hypersensitivity reactions previously. Additionally, it should not be administered to patients where gastrointestinal motility could be harmful, such as in cases of gastrointestinal bleeding, mechanical obstruction, or perforation. Since this medication contains lactose, it should not be given to patients with lactose intolerance or certain genetic metabolic disorders. Caution should be exercised as severe allergic reactions such as shock or anaphylaxis may occur while using this medication, and symptoms should be closely monitored. Due to the possibility of liver dysfunction or jaundice symptoms, liver health should be closely observed, and use should be discontinued if abnormalities are detected. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur, as well as neurological symptoms such as headache, anxiety, sleep disturbances, and dizziness. Endocrine abnormalities such as gynecomastia or elevated prolactin levels have also been reported, so treatment should be stopped if any abnormal symptoms occur. Blood tests should be conducted to check for thrombocytopenia or leukopenia, and renal dysfunction may also occur, necessitating careful observation. Rarely, hypersensitivity reactions such as skin rash, redness, pruritus, and extrapyramidal symptoms such as tremors may appear. This medication enhances acetylcholine action, so this should be considered during use, and long-term use should be avoided if gastrointestinal symptoms do not improve. The effect of this medication may be reduced when taken with anticholinergics, thus caution with dosage intervals is advised. Women who are pregnant or may become pregnant should only use this medication cautiously when necessary due to the lack of established safety, and nursing mothers should either avoid it or discontinue breastfeeding. Safety in pediatric patients has not been sufficiently established, so caution is needed when prescribing. In elderly patients, adverse reactions may occur more easily due to diminished physiological function, so symptoms should be closely monitored and dosages adjusted as necessary. This medication should be stored out of the reach of children, and should not be transferred to other containers to maintain quality.

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

This medication should be stored in a tightly sealed container to prevent air or moisture ingress, and it is advisable to keep it at room temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medication.

Appearance

White, round, film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle