Exatid Capsule (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 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 continue for up to 1 year; results with longer-term administration are unknown. 3. Gastroesophageal reflux disease Adults: Administer 150mg orally twice daily, in the morning and evening. Treatment may continue 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. Dose adjustment for patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Creatinine clearance 20~50 ml/min: Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: 150mg daily Creatinine clearance < 20 ml/min: Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: 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 dose should also be reduced in these patients according to the degree of renal impairment. The clinical effects of this dose reduction in patients with renal impairment have not been evaluated.

This medication should not be used in certain patients. People who are allergic to this medication or similar medications should not take it. Additionally, since it contains lactose, individuals with a genetic disorder that prevents proper digestion of lactose should avoid using it. There are also patients who require caution when using this medication. Those with a history of drug allergies, poor liver function, or reduced kidney function should use this medication carefully. In particular, if kidney function is impaired, the dosage may need to be reduced or the dosing interval increased. While taking this medication, rare allergic reactions such as rash, itching, bronchial asthma, laryngeal edema, or severe allergic symptoms may occur. If these symptoms develop, discontinuation of the medication is required. Blood-related side effects such as anemia, leukopenia, and thrombocytopenia have been reported, and if any unusual symptoms occur, the medication should be discontinued. Gastrointestinal side effects may include constipation, diarrhea, dry mouth, and nausea. Liver dysfunction has also been reported, possibly leading to elevated liver enzymes or symptoms of hepatitis and jaundice. Neurological side effects may rarely include confusion, headache, drowsiness, dizziness, or weakness, and seizures have been reported on rare occasions. Regarding the heart, asymptomatic ventricular tachycardia may temporarily appear. In females, rare breast enlargement may occur, and in males, erectile dysfunction or decreased libido has been reported, though this is similar to normal levels. Skin-related side effects may include sweating, urticaria, rash, dermatitis, and rarely, vasculitis. Other issues have been reported such as increased uric acid levels unrelated to gout or kidney stones, fever, chest pain, muscle pain, rhinitis, pharyngitis, and cough. This medication may mask symptoms of gastric cancer, so it should only be used after confirming the absence of malignancy. Since it is primarily excreted through the kidneys, patients with moderate to severe kidney dysfunction require dosage adjustment. During treatment, it is advisable to closely monitor symptom changes, and if effective results are not observed, switching to other treatments may be warranted. There is insufficient pharmacokinetic research regarding patients with liver and kidney dysfunction, so caution is necessary. This medication has relatively fewer drug interactions with other specific medications and does not significantly affect liver metabolism. Women who are pregnant or may become pregnant need to carefully consider the benefits and risks when using this medication. Lactating women should only take this medication when absolutely necessary, and safety in children has not been established. Elderly patients are at a higher risk of decreased kidney function and should undergo renal function testing and dosage adjustments, while their renal condition should be closely monitored during administration. Symptoms of overdose may include vomiting, diarrhea, increased salivation, and constricted pupils, and treatment may require supportive therapy based on clinical examination and symptoms. This medication is not effectively removed by hemodialysis, so caution is needed in cases of overdose. Animal studies have not shown evidence of carcinogenicity with long-term high-dose administration; however, some liver changes have been observed. In pregnant animals, high doses may affect the fetus, so caution is necessary when used during pregnancy. In lactating animals, the drug may be secreted into milk and affect the growth of offspring, so caution is warranted. Erectile dysfunction symptoms have been reported rarely following this medication, which should be noted.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is also advisable to keep the medication at room temperature between 1°C and 30°C, avoiding excessively hot or cold conditions.

Appearance

Capsule filled with white to grayish-white powder: upper part yellow, lower part light yellow

Package unit

30 capsules/bottle, 100 capsules/bottle