Nizatide Capsule (Nizatidine)

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or 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. 2. Prevention of recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may be continued for up to 1 year; results of longer-term administration 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. Dosage adjustment for patients with severe renal impairment The dosage for patients with renal impairment should be reduced and adjusted 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 dosage should also be reduced in these patients according to the degree of renal impairment. The clinical effects of this dosage reduction in patients with renal impairment have not been evaluated.

This drug is an H2-receptor antagonist that is used to inhibit gastric acid secretion. This medication should not be used in patients who have previously had an allergic reaction to this drug or other H2-receptor antagonists. Precaution is necessary when administering to individuals with hypersensitivity to the drug. Caution should also be exercised in patients with poor liver function, and it is important to periodically check liver function in cases of liver impairment. Patients with reduced kidney function may have the drug remain in the body for a prolonged period, requiring a reduction in dose or an increase in dosing interval. This drug contains a coloring agent called Yellow No. 5, so patients who are allergic to this component should use it with caution. If allergic reactions such as rash, itching, difficulty breathing, or swelling of the face or neck occur during use, discontinue the drug immediately and consult a physician. Blood abnormalities such as anemia, leukopenia, or thrombocytopenia may occur, so regular blood tests are necessary. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, or nausea may arise, and healthcare personnel should be informed if such symptoms occur. Liver enzyme levels may rise, or symptoms of hepatitis and jaundice may occur, so it is important to periodically monitor liver health. Rarely, neurological symptoms such as confusion, headache, drowsiness, or dizziness may arise; caution is advised. Symptoms of tachycardia may occur, so monitoring the heart condition is necessary. In women, gynecomastia may rarely occur, while men have reported erectile dysfunction or decreased libido. Skin reactions such as rash, hives, or sweating may occur, so report any abnormal symptoms. Hyperuricemia may occur; therefore, caution is needed in patients with gout or kidney stones. This drug can mask symptoms of gastric cancer, so confirm that a malignant condition is not present before use. Patients with impaired kidney function require dosage adjustments; therefore, it is advisable to determine the dose after performing kidney function tests. Women who are pregnant or may become pregnant should use this drug only when the benefit outweighs the risks, as the effects on the fetus are not clear. Lactating women should use this drug only when necessary, as it is secreted into breast milk. The safety of this drug for children has not been established, so use it with caution. Elderly patients are at higher risk for decreased kidney function, so they should have kidney function tests before administration and closely monitor kidney status during treatment. This drug has relatively few serious interactions with other medications, but caution is advised when used together with high-dose aspirin, as it may increase serum salicylate levels. Overdose may result in symptoms such as vomiting, diarrhea, and miosis, and in such cases, measures such as inducing vomiting or gastric lavage may be necessary. This drug is not effectively removed by hemodialysis, so alternative treatment methods should be considered in the event of an overdose.

• rash
• itching
• bronchial asthma
• swelling of the larynx
• anaphylactic symptoms
• anemia
• leukopenia
• neutrophilia
• thrombocytopenic purpura
• constipation

This medication should be stored in a tightly sealed container to prevent air ingress and kept at room temperature between 1°C and 30°C. Storing it this way will help maintain the drug's effectiveness for a longer duration.

Appearance

A hard capsule filled with white to pale gray powder, purple upper part, and yellowish lower part

Package unit

30 capsules, 300 capsules/bottle