Zatinol Capsule 150 mg (Nizatidine)

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or 150mg orally 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. 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 administration 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 for patients with renal impairment should be reduced 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

This medication should not be used in certain patients. It must not be administered to patients who have had allergic reactions to this medication or similar drugs. Additionally, as it contains lactose, it should not be given to patients with lactose intolerance or certain genetic metabolic disorders. Caution is advised when this medication is used in patients with hypersensitivity to drugs, poor liver function, or impaired kidney function. In particular, patients with reduced kidney function may experience increased concentrations of this medication, necessitating a reduction in dosage or an extension of the dosing interval. Rarely, allergic symptoms such as skin rash, itching, and difficulty breathing may occur during the use of this medication, necessitating immediate discontinuation if such symptoms arise. Additionally, anemia or changes in blood cell counts may occur, warranting consultation with a physician if abnormal symptoms appear. Gastrointestinal adverse effects may include constipation, diarrhea, dry mouth, and nausea. Liver dysfunction may occur, with elevations in liver enzymes or signs of jaundice requiring vigilance. Cognitive disturbances, headaches, drowsiness, and dizziness may rarely arise, and palpitation may occur. Breast enlargement has been noted in women, and some men have reported erectile dysfunction or reduced libido. Skin reactions such as rash, sweating, and urticaria may also occur. This medication can mask symptoms of gastric cancer; therefore, it should be used only after confirming the absence of malignancy. Patients with reduced kidney function may require dosage adjustments, and during treatment, regular blood tests and liver and kidney function tests should be performed. Pregnant or breastfeeding women should use this medication cautiously, as its safety has not been fully established. Safety in children has not been established, and elderly patients are likely to have reduced kidney function, necessitating kidney function tests prior to administration. In the case of overdose, symptoms such as vomiting, diarrhea, and increased salivation may occur, and in severe cases, appropriate medical attention may be required. This medication is not removed by dialysis, so alternative treatment methods should be considered in the event of an overdose. Lastly, while significant interactions with other drugs have not been reported, caution is warranted as co-administration with high-dose aspirin may increase blood levels of certain components. Finally, although some liver changes were observed in animal studies with prolonged high-dose administration of this medication, carcinogenicity and genetic toxicity have not been confirmed. In animal studies during pregnancy, some fetal abnormalities were reported; thus, pregnant women should ensure to consult a physician before administration. During breastfeeding, as the drug may be excreted in breast milk, it should only be used when absolutely necessary.

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

This medication should be stored in a tightly closed container to prevent air exposure, preferably at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the efficacy and prevent degradation of the medication.

Appearance

A yellow hard capsule filled with white to nearly white powder.

Package unit

30 capsules/bottle, 300 capsules/bottle