Newtolid 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 in patients who have had allergic reactions to this medication or its components. It should also not be administered to patients where stimulation of gastrointestinal motility may be harmful, such as in cases of gastrointestinal bleeding, mechanical obstruction, or perforation. This medication contains lactose; therefore, it should not be used by patients with genetic galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients should be closely monitored for severe allergic reactions such as shock or anaphylaxis while using this medication. If symptoms such as blood pressure drop, difficulty breathing, hives, pallor, or sweating occur, immediate discontinuation of the drug and appropriate treatment should be provided. Since liver function impairment or jaundice symptoms may occur, regular liver function tests should be performed, and the medication should be discontinued if any abnormalities are detected. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur, as well as psychiatric symptoms such as headache, anxiety, sleep disturbance, and dizziness. Endocrine disorders such as gynecomastia or increased prolactin levels may occur; if such symptoms appear, discontinuation of the drug is recommended. Hematological abnormalities such as thrombocytopenia or leukopenia may occur, necessitating regular blood tests, and the drug should be discontinued if any abnormalities are discovered. Elevations in BUN and creatinine levels may be noted in kidney function tests, requiring caution. Liver enzyme levels such as AST, ALT, γ-GTP, and ALP may increase, so the liver health status should be monitored periodically. Hypersensitivity reactions such as rash, redness, and itching may occur rarely; if these symptoms develop, drug discontinuation is advised. Extrapyramidal symptoms such as tremors may occur, and if any unusual symptoms arise, appropriate action should be taken, including discontinuation of use. Chest or back pain and fatigue may also occur, so it's important to pay attention to symptoms. Since this medication increases acetylcholine action, it should be used with consideration of this factor, and long-term use is not recommended if gastrointestinal symptoms do not improve. When taken with anticholinergic agents, the effectiveness of this medication may decrease, so dosing intervals should be adjusted, and use in combination should be approached with 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. During breastfeeding, this medication may be secreted in breast milk, so it should be avoided, or if unavoidable, breastfeeding should be stopped. Safety in children has not been sufficiently confirmed, so caution is advised in usage. Elderly patients may have decreased bodily functions and an increased likelihood of adverse reactions; therefore, symptoms should be closely monitored, and dosage adjustments or discontinuation may be necessary as needed.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to store at room temperature between 1 to 30 degrees Celsius. This helps maintain the medication's effectiveness for a longer period.

Appearance

White round film-coated tablets

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 300 tablets/bottle