Nizatil 150 mg (Nizatidine)

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or 150mg twice daily, in the morning and evening, by oral administration. 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 duodenal ulcer recurrence 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 treatment 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 dose should be reduced and adjusted as follows in patients with renal impairment. 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. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

This medication should not be used in patients with hypersensitivity to H2-receptor antagonists. Patients with a history of drug allergies or problems concerning liver or kidney function should use this medication with caution. In particular, for patients with impaired kidney function, drug concentration may increase, warranting a reduction in dosage or an increase in dosing intervals. If allergic symptoms such as skin rash, itching, or difficulty breathing occur during treatment, the use of this medication should be immediately discontinued. Abnormal blood symptoms may include anemia, decreased white blood cell count, and thrombocytopenic purpura, thus if any abnormal symptoms arise, the medication should be stopped, and a doctor should be consulted. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, nausea may also occur. Liver function may be affected, potentially leading to elevated liver enzyme levels or symptoms of hepatitis and jaundice, therefore caution is advised. Neurological adverse effects can include transient confusion, headache, drowsiness, dizziness, and lethargy, albeit infrequently. Asymptomatic ventricular tachycardia with increased heart rate may occur, and some patients may report gynaecomastia or sexual dysfunction. Dermatological reactions such as sweating, urticaria, rash, dermatitis, and rarely vasculitis may also occur. This medication may induce hyperuricemia, with symptoms such as fever, chest pain, myalgia, rhinitis, pharyngitis, and cough reported. This medication can mask symptoms of stomach cancer, so it should only be used after confirming malignancy. Since it is primarily excreted through the kidneys, patients with severe kidney impairment require dosage adjustments. While monitoring treatment effects, the minimal effective dose should be used, and if ineffective, switching to alternative therapy is recommended. Women who are pregnant or breastfeeding should use this medication cautiously, as its safety has not been established, and it should only be used if necessary. Safety in children has not been established, and elderly patients are at higher risk for renal function decline, hence kidney function tests are recommended prior to administration. In cases of overdose, symptoms such as vomiting, diarrhea, and miosis may appear, and clinical tests and supportive therapy should be sought if necessary.

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

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is advised to store it at room temperature between 15 to 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle