Newzatin 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. 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 for 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 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 Creatinine clearance may be reduced to below 50mL/min in some older adults. Based on pharmacokinetic data in patients with renal impairment, the dosage should also be reduced in these patients according to the degree of renal impairment. The clinical effects of this dosage reduction in patients with renal impairment have not been evaluated.

This medication should not be used in specific patients. Individuals who have had allergic reactions to this medication or similar drugs should not take it. Caution is warranted for those with lactose intolerance or certain genetic metabolic disorders as it contains lactose. Patients with allergies to the medication or with liver or kidney problems should exercise special caution when using this medication. In patients with impaired kidney function, the drug concentration may increase, thus requiring a reduced dosage or extended dosing intervals. If symptoms of allergy such as skin rash, itching, or difficulty in breathing occur during treatment, use should be discontinued immediately. Abnormal blood symptoms, for example, anemia or changes in blood cell counts may occur, and if any abnormal symptoms arise, they should be reported to a hospital. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, and nausea may rarely occur. As it may affect liver function, there is a risk of elevated liver enzymes or symptoms of hepatitis and jaundice, thus requiring caution. Psychological disturbances, headaches, drowsiness, and dizziness may rarely occur, and in severe cases, seizures may happen. Temporary increases in heart rate may occur. In women, breast enlargement symptoms have been reported rarely, while in men, erectile dysfunction or decreased libido may occur, but these are not common. Sweating, urticaria, rashes, and skin inflammation can occur, and abnormal symptoms should be reported immediately. This drug may increase uric acid levels, so patients with gout or kidney stones should be cautious. This drug can mask symptoms of gastric cancer, so it is important to confirm that there is no malignant condition before use. Since it is primarily excreted through the kidneys, patients with impaired kidney function require dosage adjustments. During treatment, regular blood tests and assessments of liver and kidney function should be performed to monitor the condition. Women who are pregnant or may become pregnant should only use this medication if the benefits are judged to outweigh the risks. Lactating women should take this medication only if necessary, as it may pass into breast milk. The safety and effectiveness in children have not been established, therefore, its use is not recommended. Elderly patients have a higher risk of decreased kidney function, so kidney function tests should be performed before administration, and renal status should be closely monitored during treatment. Overdose of this medication may result in symptoms such as vomiting, excessive salivation, miosis, and diarrhea, and if needed, measures such as inducing vomiting or gastric lavage should be considered. This medication has minimal risk for interactions with other drugs as it does not significantly affect drug metabolism; however, caution is advised as blood concentration changes may occur when combined with certain medications.

• 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 ingress, and the storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy over a longer period.

Appearance

Capsule filled with white to off-white powder; upper part is yellow, lower part is light yellow.

Package unit

(For domestic use) 30 capsules/bottle, 300 capsules/bottle, (For export) 30 capsules (10 capsules x 3 PTP)