Nizatidine Capsule 150 mg (Nizatidine)

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer nizatidine 300mg once daily at bedtime, or 150mg twice daily, in the morning and evening, orally. 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 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; outcomes of longer-term treatment are not known. 3. Gastroesophageal reflux disease Adults: Administer 150mg 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 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 according to the degree of renal impairment in these patients. The clinical impact of such dose reductions in patients with renal impairment has not been evaluated.

This drug should not be used in patients who have had an allergic reaction to this drug or other H2-receptor antagonists. Additionally, this drug contains lactose and should not be given to patients with a genetic disorder who cannot digest lactose. This drug should be used cautiously in patients who have had allergic reactions to medications, those with poor liver function, and those with decreased kidney function, and in cases of weak kidney function, the dosage should be reduced or the dosing interval should be extended. There may be rare allergic symptoms such as skin rash, itching, and difficulty breathing when using this drug, and if these symptoms occur, use should be stopped immediately. Blood abnormalities such as anemia, leukopenia, and thrombocytopenia may occur, so if any abnormal symptoms arise, use should be stopped and a doctor should be consulted. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, nausea may occur. It may affect liver function, leading to elevated liver enzyme levels or symptoms such as hepatitis and jaundice, so liver status should be checked periodically. In the nervous system, rare symptoms such as confusion, headache, drowsiness, dizziness, and lethargy may occur, and seizures may rarely occur. There may be asymptomatic ventricular tachycardia occurring temporarily in the heart. In women, rare symptoms of breast enlargement may occur, and in men, erectile dysfunction or decreased libido has been reported but is similar to the general level. Skin reactions may include sweating, urticaria, rash, dermatitis, and rarely vasculitis. This drug can cause an increase in serum uric acid levels unrelated to gout or kidney stones, and symptoms such as fever, chest pain, myalgia, rhinitis, pharyngitis, and cough have also been reported. This drug may mask symptoms of gastric cancer, so it should only be used after it has been confirmed that cancer is not present. Since this drug is primarily excreted through the kidneys, patients with moderate to severe kidney dysfunction should adjust the dosage. During treatment, regular blood tests and liver and kidney function tests should be conducted while administering the minimum effective dose, and if there is no effect, another treatment should be considered. This drug is metabolized partially in the liver, but pharmacokinetic studies have not been adequately conducted in patients with liver and kidney disease. This drug generally has minimal interactions with other medications, but when used together with aspirin in high doses, serum salicylate levels may increase. Women who are pregnant or may become pregnant should use this medication only when the benefits are greater than the risks, and nursing mothers should use it only when absolutely necessary. Safety and efficacy in children have not been established. Elderly patients are more likely to have decreased kidney function, so kidney function should be tested before administration, and the kidney status should be carefully monitored during administration. This drug may produce false-positive results in some clinical tests, so caution is needed in interpreting test results. In case of overdose, symptoms such as vomiting, diarrhea, excessive salivation may appear, and in such cases, clinical tests and supportive treatment should be implemented, and activated charcoal or gastric lavage should be considered if necessary. This drug is not well eliminated by dialysis, so blood dialysis is not effective. Animal experiments have shown some liver changes with long-term high dose use, but there is no evidence of carcinogenicity, and adverse effects on genotoxicity or reproductive capability have not been confirmed. High-dose administration in pregnant animals has been reported to cause some fetal abnormalities, but safety in humans is not sufficiently known, so it should be used cautiously during pregnancy. This drug is secreted in small amounts into breast milk, so caution is needed when administering during breastfeeding. In elderly patients or those with decreased kidney function, the drug's toxic reactions may be more pronounced, so caution is needed.

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

This drug should be stored in a tightly sealed container to prevent air ingress, preferably at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness.

Appearance

Hard capsule with yellow upper part and light yellow lower part filled with white to almost white powder

Package unit

30 capsules/bottle, 300 capsules/bottle