Itorapine Tablets (Itopride Hydrochloride)

Adult dose

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

This drug should not be used by patients with hypersensitivity or a history of allergic reactions to the components of this drug. It may be dangerous to administer this medication to patients with gastrointestinal issues such as gastrointestinal bleeding, mechanical obstruction, or perforation, and thus should be avoided. Additionally, this drug contains lactose, so it is safer for patients with genetic disorders that prevent lactose digestion not to use it. While taking this drug, serious allergic reactions such as shock or anaphylaxis may occur, so symptoms should be monitored closely. Liver function can be affected, and if liver enzyme levels rise or jaundice symptoms appear, the medication should be stopped immediately and medical attention sought. Digestive symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur, and medical consultation is necessary if these symptoms arise. Neurological symptoms such as headache, anxiety, sleep disturbances, and dizziness may also occur and require caution. Endocrine abnormalities such as gynecomastia or increased prolactin levels may occur, so any unusual symptoms should be reported to healthcare personnel. Blood abnormalities such as thrombocytopenia or leukopenia may arise, making regular blood tests necessary. Kidney function may be affected, so it is advisable to check BUN and creatinine levels. Rarely, skin rashes, redness, or itching may occur, so any skin abnormalities should be reported immediately. Extrapyramidal symptoms such as tremors may occur, so these symptoms should be communicated to healthcare personnel. Chest or back pain and fatigue have also been reported infrequently, so attention should be paid to these symptoms. This medication enhances the action of acetylcholine, so this should be considered in its use, and long-term use should be avoided if digestive symptoms do not improve. When taken with anticholinergic agents, the effect of this drug may be reduced, so care should be taken in adjusting the dosing intervals. Pregnant women or those who may become pregnant should carefully evaluate the benefits and risks of using this drug, and nursing mothers should avoid administration or discontinue nursing. The safety for children has not been adequately established, so caution is needed when used. Elderly patients may have a higher risk of adverse reactions due to decreased physical function, so careful observation and dose adjustments are necessary when taking this drug. This medication should be kept out of reach of children, and it is important to not transfer it to another container to maintain safety and quality.

• Shock
• anaphylactic-like symptoms
• hypotension
• respiratory distress
• laryngeal edema
• urticaria
• pallor
• sweating
• liver dysfunction
• jaundice

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 500 tablets/bottle