Nizatidine Capsule 150 mg (Nizatidine)

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Administer 300mg of nizatidine per dose once daily at bedtime, or administer 150mg per dose 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 Adults: After healing of a duodenal ulcer, administer 150mg per dose orally once daily at bedtime. Treatment may be continued for up to 1 year; results for longer-term treatment are not known. 3. Gastroesophageal reflux disease Adults: Administer 150mg per dose 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 per dose 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 and adjusted as follows. Creatinine clearance Dose Active duodenal ulcer Gastroesophageal reflux disease (GERD) Benign gastric ulcer 20~50 ml/min 150mg daily < 20 ml/min 150mg every other day Maintenance therapy 20~50 ml/min 150mg every other day < 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 according to the degree of renal impairment in these patients. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

This medication should not be used in patients who have had allergic reactions to this or other H2-receptor antagonists in the past. Additionally, this medication contains lactose and should not be administered to patients with a genetic inability to digest lactose. Patients with a history of drug allergies, impaired liver function, and decreased kidney function should use this medication with caution, and especially in cases of poor kidney function, the dosage should be reduced or the dosing interval prolonged. Rarely, symptoms such as skin rash, itching, asthma, laryngeal edema, and severe allergic reactions may occur, and if these symptoms develop, use should be stopped immediately. Blood-related adverse symptoms such as anemia, leukopenia, and thrombocytopenia have been reported, so medication should be discontinued if such symptoms occur. Gastrointestinal side effects might include constipation, diarrhea, dry mouth, and nausea. Liver function abnormalities may occur, and symptoms such as hepatitis or jaundice have been reported rarely, so liver health should be monitored closely. There may be symptoms of mental confusion, headache, drowsiness, dizziness, and lethargy, and cases of seizures have been reported rarely. Rapid heart rate may occur temporarily. Rarely, symptoms of breast enlargement in females may appear, and erectile dysfunction or reduced libido has also been reported, but this is similar to the general level. Skin rashes, urticaria, sweating, dermatitis, and rarely, vasculitis may occur. Other symptoms unrelated to gout or kidney stones, such as elevated uric acid levels, fever, chest pain, muscle pain, rhinitis, pharyngitis, and coughing may appear. This medication may mask symptoms of stomach cancer, so it must be confirmed that the condition is not malignant before use. This medication is primarily excreted through the kidneys, so dosage adjustments are necessary for patients with moderate to severe kidney impairment. It is advised to use the minimal effective dose while monitoring therapeutic effects, and to switch to another medication if there is no efficacy. There is insufficient research on drug metabolism in patients with liver and kidney dysfunction, but it is used at standard doses in patients with normal liver function. This medication has fewer interactions with specific drugs, but using it with high-dose aspirin may increase serum levels of aspirin. Pregnant women or women who may become pregnant should carefully consider the benefits and risks when using this medication, and lactating women should only use it when absolutely necessary. Safety in pediatric patients has not been established, and elderly patients may have a risk of declining kidney function, so kidney function testing is necessary before administration and careful monitoring is required during use. In cases of overdose, symptoms such as vomiting, diarrhea, increased salivation, and pupillary constriction may occur, and clinical examination and supportive treatment may be required. This medication cannot be effectively removed by blood dialysis; alternative treatment methods should be considered in the event of an overdose. Animal studies have shown no evidence of carcinogenicity with long-term high-dose administration, but some cases of liver tumors and liver damage have been reported, thus caution is needed. Some malformations or miscarriages have been reported in pregnant animal studies; hence, careful judgment is required for use during pregnancy. This medication is excreted in small amounts in breast milk, so lactating women should carefully decide on the administration of the drug. Cases of erectile dysfunction have been reported rarely following medication use, so consultation with a doctor is necessary if such symptoms appear.

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

This medication should be stored in a tightly sealed container to prevent air or humidity from entering, and it is best stored at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's efficacy for a long time.

Appearance

Capsule filled with white-light gray powder: yellow upper part and light yellow lower part

Package unit

30 capsules/bottle, 100 capsules/bottle