Nizagreen Tablet 150 mg (Nizatidine)

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer nizatidine 300mg orally once daily at bedtime, or 150mg 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 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 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 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 Creatinine clearance may be reduced to below 50mL/min in some elderly patients. 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 this dose reduction in patients with renal impairment has not been evaluated.

This drug should not be used in patients with hypersensitivity to H2-receptor antagonists. Caution should be exercised when using this medication in patients with a history of allergic reactions to the drug or in those with liver or kidney impairment. In particular, patients with compromised kidney function may have elevated drug blood concentrations, necessitating a reduction in dosage or an increase in dosing intervals. If allergic symptoms such as rash, pruritus, bronchial asthma, or laryngeal edema occur while taking this medication, it should be discontinued immediately. There have been reports of hematologic abnormalities such as anemia, leukopenia, and thrombocytopenia; if any abnormal symptoms occur, drug cessation is necessary. Occasional gastrointestinal side effects such as constipation, diarrhea, dry mouth, and nausea may occur. There may also be a need for caution due to an increase in liver function test values or signs of liver damage such as hepatitis and jaundice. Rarely, neurological side effects such as confusion, headache, drowsiness, dizziness, and weakness may occur, and some have reported seizures. Asymptomatic ventricular tachycardia (rapid heartbeat) may occur in the short term. Rarely, breast enlargement in women, decreased libido, and erectile dysfunction have been reported. Skin reactions such as rash, sweating, urticaria, dermatitis, and vasculitis may occur. This medication may precipitate hyperuricemia unrelated to gout or kidney stones, with symptoms such as fever, chest pain, muscle pain, rhinitis, pharyngitis, and cough reported. This medication can mask symptoms of gastric cancer, so it should only be used after confirming the absence of malignant disease. Since it is mainly excreted through the kidneys, patients with moderate to severe renal impairment should have their dosage reduced, and the minimum effective dosage should be used while monitoring therapeutic effects and side effects. There is a lack of pharmacokinetic studies in patients with liver and kidney dysfunction; therefore, caution is advised. This drug generally has few interactions with other specific medications. However, when taken with high-dose aspirin, the serum salicylate concentration may increase. Women who are pregnant or may become pregnant should take this medication only when the benefits outweigh the risks, and breastfeeding women should use it only when absolutely necessary. Safety and efficacy in pediatric patients have not been established. Elderly patients are at increased risk for renal function decline, so kidney function should be assessed before and monitored during treatment. In case of overdose, symptoms may include vomiting, diarrhea, and increased salivation. Induction of vomiting, gastric lavage, or administration of activated charcoal may be necessary. Blood dialysis is not an effective means to remove this medication. Animal studies have shown no evidence of carcinogenicity or genotoxicity, and it has been reported not to significantly affect reproductive ability. The impact of use during pregnancy on the fetus is unclear, so it should be used with caution, and it should be noted that the drug can be secreted in breast milk during lactation.

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is advisable to keep it in a cool place between 15 and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle