Axididine Capsule (Nizatidine)

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer 300 mg of nizatidine once daily at bedtime, or 150 mg 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. In cases of active gastric ulcer, malignancy must be ruled out before treatment. 2. Prevention of duodenal ulcer recurrence After healing of a duodenal ulcer, adults should take 150 mg 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 should take 150 mg orally twice daily, in the morning and evening. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults should take 150 mg orally twice daily, in the morning and evening, for 2 weeks. 5. Dosage adjustment for patients with severe renal impairment The dose for patients with renal impairment should be reduced as follows. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer Creatinine clearance 20~50 ml/min: 150mg daily 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 impairment, the dose should also be reduced in such patients according to the degree of renal impairment. The clinical effects of this dose reduction in patients with renal impairment have not been evaluated.

This medication should not be used in certain patients. Patients who have had an allergy to this drug or other H2-receptor antagonists should not take this medication. In addition, as it contains lactose, patients with lactose intolerance or related genetic conditions should not take this drug. This drug should be administered with caution to patients with a history of drug allergies, poor liver function, and impaired kidney function. In particular, patients with poor kidney function may experience increased drug concentration, requiring a reduction in dosage or an increase in dosing intervals. While taking this medication, serious allergic reactions such as skin rash, itching, difficulty breathing, and anaphylaxis may occur, so if such symptoms develop, patients should immediately stop taking the drug. Blood abnormalities may cause anemia, leukocyte count changes, and thrombocytopenia, so any unusual symptoms should prompt consultation with a physician. Gastrointestinal side effects may include constipation, diarrhea, dry mouth, and nausea. Liver function test levels may rise, and symptoms of hepatitis and jaundice have been rarely reported, so liver health should be monitored carefully. Psychological symptoms such as confusion, headache, drowsiness, and dizziness may occur, and seizures may rarely occur. Cardiac symptoms may include transient tachycardia. In women, breast enlargement may rarely occur, and sexual dysfunction has also been reported. Skin reactions may include sweating, urticaria, rash, dermatitis, and vasculitis. This medication may cause elevated uric acid levels unrelated to gout or kidney stones, along with symptoms such as fever, chest pain, muscle pain, rhinitis, pharyngitis, and cough. This medication may mask symptoms of stomach cancer, so it should be used only after confirming the absence of malignant tumors. It is primarily excreted through the kidneys, so dose adjustments are necessary for patients with decreased kidney function. Regular blood tests and liver and kidney function tests should be conducted during treatment, and if ineffective, it is recommended to switch to another medication. This medication does not have significant interactions with other drugs and does not inhibit liver metabolic enzymes, thus not affecting drug metabolism. However, caution is advised when taking it in combination with high doses of aspirin, as the concentration of some components may increase. Pregnant or breastfeeding women should use this medication only when absolutely necessary, as its safety has not been established. While nursing, the drug may be excreted into breast milk, which necessitates careful decision-making. Safety for pediatric use has not been established, and elderly patients are at greater risk for decreased kidney function and should undergo kidney function tests before administration and be monitored carefully during treatment. Overdose of this medication may present as vomiting, diarrhea, increased salivation, and pupil constriction, and in severe cases, special treatment and supportive care may be required. This medication cannot be effectively removed through hemodialysis. Long-term administration at high doses did not show carcinogenic evidence in animal studies; however, certain liver tissue changes were observed. No specific issues were found in mutagenic or reproductive toxicity testing. In studies on pregnant animals, some fetal abnormalities were reported at very high doses, but safety in humans remains unclear. In lactating animals, the drug may be secreted in breast milk and may cause growth inhibition in offspring; thus, breastfeeding women should carefully consider whether to take the drug. This medication may rarely cause sexual dysfunction such as erectile dysfunction, so it is advisable to consult with a professional if any unusual symptoms arise.

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

This medication may be sensitive to air and moisture, so it should always be stored in a tightly sealed container. Additionally, it is recommended to store the drug at room temperature between 1 to 30 degrees Celsius. Avoid extremely hot or cold places, and maintain appropriate temperatures to preserve the drug's effectiveness.

Appearance

A hard capsule with yellow upper part and light yellow lower part, containing a crystalline powder or small lumps that are off-white to pale yellow in color.

Package unit

30 capsules/bottle, 500 capsules/bottle