Nizatidine M Capsule (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. 2. Prevention of recurrence of duodenal ulcers After healing of a duodenal ulcer, adults should take 150mg orally once daily at bedtime. Treatment may be continued for up to 1 year; results of longer-term treatment are unknown. 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 in patients with severe renal impairment The dose 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 Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance < 20 ml/min, 150mg every other day Maintenance therapy: Creatinine clearance 20~50 ml/min, 150mg every other day Maintenance therapy: 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 these patients according to the degree of renal impairment.

This medication should not be administered to certain patients. Patients who have had an allergic reaction to this medication or other H2-receptor antagonists should not use it. Additionally, it contains lactose, so patients with lactose intolerance or genetic lactose degradation disorders should not take it. This medication should be used with caution in some patients. Special attention is required for patients with a history of hypersensitivity to the drug, and those with poor liver or kidney function should be particularly careful. Since the concentration of this drug may increase in patients with decreased kidney function, the dosage should be reduced or the dosing interval should be lengthened. This medication contains yellow dye, which may require caution in patients with a dye allergy. While taking this medication, rare occurrences of skin rashes, itching, breathing difficulties, severe allergic reactions, etc., may arise, and if such symptoms develop, dosing should be stopped immediately. Adverse effects may include blood abnormalities, constipation or diarrhea, nausea, liver function abnormalities, mental confusion, headache, drowsiness, dizziness, weakness, transient asymptomatic ventricular tachycardia, gynecomastia, erectile dysfunction, decreased libido, sweating, rashes, exfoliative dermatitis, and rarely, vasculitis, hyperuricemia, fever, chest pain, and muscle pain. This medication can mask symptoms of gastric cancer, so it should be used only after confirming that it is not a malignant condition. It is primarily excreted through the kidneys, so patients with decreased kidney function should adjust the dosage, and it is important to periodically monitor liver and kidney function during treatment. This medication does not have significant interactions with many other drugs; however, caution is advised when taken with high-dose aspirin, as some component concentrations may increase. The safety of this medication in pregnant or breastfeeding women has not been established, so it should only be used if necessary under the discretion of a physician. The safety in pediatric patients has also not been adequately confirmed. Elderly patients are at higher risk for decreased kidney function, so they should have kidney function tests done before taking and be carefully monitored during treatment. This medication can influence some clinical test results, so healthcare professionals should consider this when interpreting test results. In case of overdose, symptoms such as vomiting, diarrhea, and pupil constriction may occur; emergency treatment and supportive therapy should be provided if necessary. This medication is not well removed by dialysis; therefore, specific treatment may be necessary in cases of overdose.

• Rash
• itching
• bronchial asthma
• laryngeal swelling
• 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. Additionally, it is best to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

A hard capsule with a yellowish upper part and a light yellow lower part, containing a white to pale yellow powder or granules.

Package unit

30 capsules/bottle, 300 capsules/bottle