Nutidine Capsule 150mg (Nizatidine)

Adult dose

1. Treatment of active gastric and duodenal ulcers In adults, the dose is 300mg of nizatidine once daily at bedtime, or 150mg per dose twice daily, in the morning and evening, taken orally. 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 In adults, after healing of a duodenal ulcer, the dose is 150mg once daily at bedtime, taken orally. Treatment may be continued for up to 1 year; results for longer-term treatment are not known. 3. Gastroesophageal reflux disease In adults, the dose is 150mg per dose twice daily, in the morning and evening, taken orally. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions In adults, the dose is 150mg per dose twice daily, in the morning and evening, taken orally 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. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer Creatinine clearance 20~50 ml/min: 150mg daily Creatinine clearance < 20 ml/min: 150mg every other day Maintenance therapy Creatinine clearance 20~50 ml/min: 150mg every other day 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 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 patients who have had allergic reactions to this drug or similar medications. This drug contains lactose; therefore, patients with a genetic disorder that prevents lactose digestion should not take it. Patients with a history of allergies or those with compromised liver and kidney function should use this drug cautiously. In particular, in cases where kidney function is impaired, the drug concentration may increase, necessitating adjustment of dosage or prolonging the dosing interval. Rarely, allergic symptoms such as skin rashes, itching, and respiratory difficulties may occur; if these symptoms arise, discontinue use immediately. Blood-related adverse reactions such as anemia or changes in blood cell counts have been reported; consult a doctor if symptoms occur. Gastrointestinal disturbances such as dyspepsia, constipation, diarrhea, dry mouth, or nausea may occur. Liver function test results may show elevation, and symptoms of liver problems such as hepatitis and jaundice may appear, requiring careful monitoring. Neurological symptoms like confusion, headache, drowsiness, and dizziness have been reported rarely. Transient cardiac rhythm abnormalities may occur; patients with heart conditions should be cautious. In women, breast enlargement may occur rarely, while men have reported erectile dysfunction or decreased libido. Skin-related adverse reactions such as rashes, hives, and sweating may occur. Hyperuricemia unrelated to gout or kidney stones may develop, and symptoms like fever, chest pain, muscle pain, rhinitis, pharyngitis, and cough have also been reported. This medication may mask symptoms of stomach cancer, so it should only be used after confirming it is not a malignant condition. It is primarily excreted through the kidneys, thus patients with kidney impairment should reduce the dosage and closely monitor therapeutic effects and side effects. Regular liver and kidney function tests should be conducted while using the minimum effective dose. This drug has relatively few serious interactions with other medications, but caution may be needed when taken with certain drugs. Women who are pregnant or may become pregnant should only use this drug when the therapeutic benefits outweigh the risks, and nursing mothers should only take it when absolutely necessary. The safety in children has not been established, and elderly patients are at higher risk of reduced kidney function; they should undergo kidney function tests before use and be closely monitored. Some clinical tests may show false-positive results, which should be considered during testing. In the case of overdose, symptoms such as vomiting, diarrhea, and increased salivation may occur, and in severe cases, supportive therapy along with measures for drug elimination may be necessary. Long-term high-dose administration of this drug has not demonstrated evidence of cancer risk; however, caution is warranted due to potential liver effects. Animal studies have not clearly indicated risks related to reproductive ability or fetal malformations, thus caution is advised during pregnancy. During breastfeeding, the drug may be present in breast milk in small amounts; therefore, the effects on the newborn should be considered before taking this medication. Erectile dysfunction may occur while taking this drug; if such symptoms arise, it is advisable to consult a doctor.

• 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 exposure, and it is best kept at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness for a long time.

Appearance

A hard capsule with a yellow upper half and a light yellow lower half containing a whitish powder

Package unit

30 capsules/bottle, 200 capsules/bottle, 300 capsules/bottle