Nitadine 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, orally 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 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 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 dosage for patients with renal impairment should be reduced and adjusted as follows. Creatinine clearance Dosage 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 dosage should also be reduced according to the degree of renal impairment in these patients. The clinical effects of this dosage reduction in patients with renal impairment have not been evaluated.

This medication should not be administered to certain patients. In particular, patients with a history of hypersensitivity to this medication or other H2 receptor antagonists should not use it. Furthermore, since it contains lactose, it should not be administered to patients with lactose intolerance or hereditary lactose metabolism disorders. This medication should be used with caution in patients with a history of drug hypersensitivity, impaired liver function, and renal impairment. Particularly, in patients with weak renal function, the blood concentration of the drug may increase, so the dose should be reduced or the dosing interval extended. While using this medication, rare allergic reactions such as rash, itching, bronchial asthma, laryngeal edema, and anaphylaxis may occur; if such symptoms occur, use should be discontinued immediately. Also, blood abnormalities such as anemia, leukopenia, and thrombocytopenia may occur, and if any abnormal symptoms appear, treatment should be stopped. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, and nausea may occur, and increases in liver function test values or liver issues such as hepatitis and jaundice have also been reported. In the central nervous system, rare cases of confusion, headache, drowsiness, dizziness, and weakness may occur, and seizures have also been reported in rare cases. Heart-related issues may present as asymptomatic ventricular tachycardia, and in women, rare cases of gynecomastia have been reported. Cases of erectile dysfunction or decreased libido also occur but at a frequency similar to that of the general population. Cutaneous reactions may include sweating, urticaria, rash, dermatitis, and vasculitis. Since this medication is primarily eliminated through the kidneys, renal function tests should be conducted before administering it to elderly patients or patients with reduced kidney function, and renal status should be carefully monitored during treatment. Its safety in pregnant or nursing women has not been established; therefore, it should only be used when deemed necessary. If given to nursing mothers, it should be decided with caution since the medication may be secreted in breast milk. The safety and efficacy in children have not been adequately confirmed, so it should be used with caution in pediatric patients. This medication generally has low interaction with other drugs, but its combination with high-dose aspirin may increase blood salicylate concentration. In case of overdose, symptoms such as vomiting, diarrhea, and increased salivation may occur; in severe cases, supportive treatment and drug removal may be necessary. Blood dialysis is not effective for the removal of this medication. During treatment, it may obscure symptoms of gastric cancer, so malignancy should be adequately confirmed before use; if therapeutic effects are not observed, it is advisable to switch to another treatment. Finally, prolonged high-dose use of this medication may affect the liver, so regular liver function tests are essential.

• 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 ingress and should be kept at room temperature between 1 to 30 degrees Celsius for safety.

Appearance

Hard capsules with a yellow upper part and a light yellow lower part filled with off-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle