Prigaton 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 medicine should not be used in patients who have had an allergic reaction to this drug or its components. It should also not be administered to patients with conditions where gastrointestinal stimulation is harmful, such as gastrointestinal bleeding, mechanical obstruction, or perforation. Furthermore, this medication contains lactose; therefore, individuals with congenital galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. This medication may cause serious allergic reactions like shock or anaphylaxis, so if symptoms like low blood pressure, difficulty breathing, or hives occur during administration, discontinue it immediately and seek appropriate treatment. There may be liver function abnormalities that result in elevated liver enzymes or jaundice, so if such symptoms appear, discontinue the medication and consult a doctor. Gastrointestinal symptoms like nausea, diarrhea, constipation, abdominal pain, and excessive salivation may occur during use. Central nervous system symptoms such as headaches, anxiety, sleep disturbances, and dizziness may also occur, so caution is advised. Endocrine abnormalities such as gynecomastia or increased prolactin levels may appear; if these symptoms are present, the administration should be stopped. Blood abnormalities like thrombocytopenia or leukopenia may occur, thus regular blood tests are necessary, and administration should be discontinued if abnormalities are found. It may affect kidney function and elevate blood BUN and creatinine levels. Rarely, hypersensitivity reactions such as skin rash, redness, and itching may occur; if these symptoms appear, discontinue the medication. Extrapyramidal symptoms such as tremors may occur, and if unusual symptoms arise, administration should be stopped. Chest or back pain and fatigue may rarely occur, so body condition should be closely monitored. This medication enhances the action of acetylcholine, so care should be taken in its use; if gastrointestinal symptoms do not improve, it is advisable not to use it for long-term. When taken with anticholinergics, the effect of this medication may decrease, so it is necessary to adjust the dosing interval and use caution. Women who are pregnant or may become pregnant should only use this medication when the benefits of treatment outweigh the risks, as its safety has not been established. If breastfeeding, this medication may be secreted in breast milk; therefore, it is advisable to avoid administration, and if unavoidable, to stop breastfeeding. The safety in children has not been fully established, so it should be used cautiously. In the elderly, diminished physical function may lead to more pronounced adverse reactions, so symptoms should be observed closely, and the dose should be adjusted or discontinued if necessary. This medication should be kept out of reach of children and transferring it to another container may pose a risk of accidents and reduce quality, so caution is advised.

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

This medication should be stored in a tightly sealed container to protect it from air or moisture, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle, 500 tablets/bottle