Daraton 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 medication should not be used by patients who have had allergic reactions to this drug or its components. It should also not be administered to patients for whom gastrointestinal stimulation could be harmful, such as those with gastrointestinal bleeding, mechanical obstruction, or perforation. Furthermore, since this medication contains lactose, patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption should not take it. Serious allergic reactions such as shock or anaphylaxis may occur during treatment with this drug; if symptoms such as low blood pressure, difficulty breathing, or hives appear, administration should be stopped immediately and appropriate treatment must be sought. Liver function abnormalities or jaundice may develop, so liver function test results should be monitored closely, and if abnormalities are detected, administration should be discontinued. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur, along with neurological symptoms such as headaches, anxiety, sleep disturbances, and dizziness. Gynecomastia or elevated prolactin levels may occur; thus, patients should consult their physician if any unusual symptoms appear. Platelet and white blood cell counts may decrease, necessitating regular blood tests, and if abnormalities are found, medication may need to be stopped. Kidney function tests may show increased BUN and creatinine levels, requiring vigilance. Rarely, hypersensitivity reactions such as skin rash, redness, and itching may occur; if unusual symptoms arise, the medication should be discontinued. Extrapyramidal symptoms such as tremors may develop, making it important to inform healthcare personnel if such symptoms appear. Chest or back pain and fatigue may also present, so patients should inform their physician if these symptoms persist. This medication enhances the action of acetylcholine; hence, this must be considered during use, and if gastrointestinal symptoms do not improve, it should not be used long-term. When taken with anticholinergics, there may be counteracting effects; therefore, care should be taken with timing of doses. Pregnant women or those who may become pregnant should use this medication only when the benefits outweigh the risks, as its safety has not been established. Lactating women should avoid using this medication as it may pass into breast milk, and if necessary, breastfeeding should be suspended. Safety for pediatric use has not been sufficiently confirmed, so it should be used cautiously in children. Elderly patients may exhibit abnormal reactions more readily due to decreased bodily functions; hence, careful monitoring is necessary, considering dose adjustments or discontinuation if needed. This medication should be stored out of the reach of children and should preferably be kept in its original container, as transferring it to another container may compromise its quality.

• Shock
• anaphylactic symptoms
• hypotension
• dyspnea
• laryngeal edema
• urticaria
• pallor
• sweating
• liver dysfunction
• jaundice

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 500 tablets/bottle