Itaxnizatidine Capsule 150 mg

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or administer 150mg orally twice daily, in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if necessary. For active gastric ulcers, malignancy must be ruled out before treatment. 2. Prevention of recurrence of duodenal ulcers After healing of a duodenal ulcer, adults should take 150mg orally once daily at bedtime. Treatment may be continued for up to 1 year; results of longer-term treatment are not known. 3. Gastroesophageal reflux disease Adults: Administer 150mg orally twice daily, in the morning and evening. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Administer 150mg orally twice daily, in the morning and evening, for 2 weeks. 5. Dose adjustment for patients with severe renal insufficiency The dose for patients with renal insufficiency should be reduced and adjusted as follows. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer Creatinine clearance 20~50 ml/min: 150mg per day Creatinine clearance < 20 ml/min: 150mg every other day Maintenance therapy Creatinine clearance 20~50 ml/min: 150mg every other day Creatinine clearance < 20 ml/min: 150mg every 3 days Some elderly patients may have a creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal insufficiency, the dose should also be reduced in these patients according to the degree of renal impairment. The clinical effects of such dose reductions in patients with renal insufficiency have not been evaluated.

This medication should not be used by patients who have had allergic reactions to this medication or similar drugs. Patients with a history of drug allergic reactions or with liver or kidney function issues should be particularly cautious when using this medication. Patients with decreased kidney function may experience higher blood concentrations of the medication, so the dosage may need to be reduced or the dosing interval lengthened. If any hypersensitivity reactions such as skin rash, itching, or difficulty breathing occur while taking this medication, usage should be immediately discontinued. Anemia or abnormalities in blood cell counts may occur, so the medication should be stopped if blood test results are abnormal. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, and nausea may appear, and if these symptoms are severe, consultation with a doctor is necessary. Liver function abnormalities may arise, so if liver enzyme levels increase or jaundice symptoms appear, the healthcare provider should be notified immediately. Rarely, neurological symptoms such as confusion, headache, drowsiness, and dizziness may occur, so caution should be exercised when driving or operating machinery. There may be instances of increased heart rate, so any unusual symptoms should be reported. Breast enlargement in females may occur rarely, as well as sexual dysfunction symptoms. Rashes, sweating, and urticaria may occur on the skin, so monitor skin changes closely. This medication may affect kidney function, so particularly elderly patients or those with diminished kidney function should regularly check their kidney status while on this medication. Pregnant women or those who may become pregnant should carefully weigh the benefits and risks before using this medication. Nursing mothers should only use this medication when necessary, as it may be excreted in breast milk. Safety and efficacy in pediatric patients have not been sufficiently established, so it should be administered to children cautiously. In cases of overdose, symptoms such as vomiting, diarrhea, and increased saliva may occur, and immediate medical attention should be sought. This medication has little likelihood of interacting with other drugs; however, caution is advised when taken with high doses of aspirin. During treatment, liver and kidney functions, as well as blood test results, should be monitored regularly, and treatment should proceed with the minimum effective dosage. This medication may mask symptoms of gastric cancer, so patients should be thoroughly assessed to rule out malignant conditions before use.

• Rash
• itching
• bronchial asthma
• laryngeal edema
• anaphylactic symptoms
• anemia
• leukopenia
• neutrophilia
• thrombocytopenic purpura
• constipation

This medication should be stored in a tightly closed container to prevent air exposure and should be kept at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance

A hard capsule with a light yellow content, upper brownish-pink, lower flesh-colored

Package unit

30 capsules/bottle, 500 capsules/bottle