Alzatine 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 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 ulcers, malignancy must be ruled out before treatment. 2. Prevention of recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may continue for up to 1 year; results of 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 continue 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. Dose 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 in these 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 drug belongs to the H2-receptor antagonist class and is used to suppress gastric acid secretion for the treatment of gastric ulcers and gastroesophageal reflux disease. This drug should not be administered to patients with hypersensitivity to H2-receptor antagonists. Hypersensitivity means the body has an allergic reaction to the drug, which can be severe in some cases, leading to dangerous reactions such as anaphylaxis. Particular caution should be taken with patients who have a history of drug hypersensitivity, or with liver or kidney problems. In patients with decreased kidney function, the drug may stay in the body longer, increasing the risk of side effects, so dosage may need to be reduced or the administration interval increased. This drug contains Yellow No. 5 dye, and patients allergic or hypersensitive to this component should be administered it with caution. During medication use, if symptoms of hypersensitivity such as skin rash, itching, difficulty breathing, or hives occur, immediately discontinue the medication and consult a physician. Hematological anomalies such as anemia or leukopenia have been reported, so if any unusual symptoms are suspected, tests should be conducted, and the drug should be discontinued if necessary. Gastrointestinal side effects such as constipation, diarrhea, dry mouth, and nausea may occur, and although rare, liver dysfunction may also occur, which may require liver function tests. Mental confusion, headache, drowsiness, and dizziness may occur rarely, so caution is needed when driving or operating machinery. Cardiac side effects such as asymptomatic ventricular tachycardia may occur, so caution is warranted in patients with heart diseases. In women, gynecomastia can occur rarely, and in men, erectile dysfunction or decreased libido have been reported, but there is no significant difference compared to the general population. Skin reactions such as rash, sweating, and vasculitis may also occur, so any unusual symptoms should be reported. This medication is primarily excreted via the kidneys, so elderly patients or those with decreased kidney function may need dosage adjustments and kidney function testing. Women who are pregnant or may become pregnant should use this drug only when the benefits of treatment outweigh the risks to the fetus, as its effects on the fetus are not sufficiently known. Lactating women should also use this drug only when necessary, as it is excreted in small amounts in breast milk, and should discuss breastfeeding with their physician. Safety has not been established for children, so caution is advised. In case of overdose, symptoms such as vomiting, diarrhea, and pupil constriction may occur, and ambulance services should be sought immediately for appropriate treatment. This drug generally has few drug interactions, but caution is needed when used with aspirin in high doses as it can increase serum salicylate levels. During treatment, this drug can obscure symptoms of stomach cancer, so it should only be used after thorough confirmation that it is not a malignant condition, and regular blood tests including liver and kidney function tests are recommended if necessary.

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It should be kept at room temperature between 1°C and 30°C.

Appearance

A hard capsule with a purple upper part and a pale yellow lower part filled with white to grayish-white powder.

Package unit

30 capsules per bottle, 300 capsules per bottle