Exad Capsule (Nizatidine)

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or take 150mg orally 2 times daily, in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if necessary. For active gastric ulcers, malignancy must be ruled out before treatment. 2. Prevention of duodenal ulcer recurrence After healing of a duodenal ulcer, adults should take 150mg orally once daily at bedtime. Treatment may be continued for up to 1 year; results of longer-term treatment are not known. 3. Gastroesophageal reflux disease Adults should take 150mg orally 2 times daily, in the morning and evening. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults should take 150mg orally 2 times 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 impact of this dose reduction in patients with renal impairment has not been evaluated.

This medication should not be used by those who have had allergic reactions to H2-receptor antagonists. Patients with hypersensitivity to the drug or with liver or kidney function problems should use it with caution. Particularly, in patients with impaired kidney function, the drug concentration may increase, necessitating a reduction in dose or lengthening the interval between doses. If allergic symptoms such as rash, itching, or difficulty in breathing occur during administration, discontinue use immediately. Blood-related adverse symptoms such as anemia, leukopenia, and thrombocytopenia may occur, so consult your doctor if you notice any abnormal symptoms. Gastrointestinal issues may include constipation, diarrhea, dry mouth, nausea. It may affect liver function, leading to elevated liver enzymes or symptoms such as hepatitis and jaundice. Central nervous system symptoms can occasionally include confusion, headache, drowsiness, and dizziness, with rare reports of seizures. Asymptomatic ventricular tachycardia with an increased heart rate may occur. In women, gynecomastia can rarely occur, and incidents of erectile dysfunction or decreased libido have been reported. Skin-related side effects may include sweating, urticaria, rash, dermatitis, and rarely vasculitis. This medication may induce hyperuricemia, with symptoms including fever, chest pain, muscle pain, rhinitis, pharyngitis, and cough having been reported. This medication may mask symptoms of stomach cancer, so use should be after confirming it is not cancer. Since primarily excreted through the kidneys, a dose adjustment is needed for patients with moderate to severe renal function impairment. Carefully observe the course of treatment, use the minimal effective dose, and switch to other treatments if there is no effect. Although there is insufficient pharmacokinetic data for patients with liver or renal diseases, it can be administered at standard doses if liver function is normal and without complications. This medication does not have significant interactions with specific drugs and does not inhibit liver metabolic enzymes, thereby presenting a low risk of drug interactions. Pregnant or potentially pregnant women should only use this medication if the benefits outweigh the risks, and breastfeeding should occur only when necessary. Safety for children has not been established, and dosage should be adjusted for the elderly based on kidney function tests, with close monitoring during treatment. This medication may cause false-positive results in urobilinogen tests. In case of overdose, symptoms such as vomiting, diarrhea, and increased salivation may occur, and treatment should include clinical evaluation and supportive therapy, activated charcoal administration, and gastric lavage. Hemodialysis is not effective in removing this medication. Animal studies have shown it to have a low risk of carcinogenicity or genotoxicity and not significantly impact reproductive capabilities. The effects on the fetus during pregnancy are not fully understood, so it should be administered cautiously. This medication is secreted in small amounts in breast milk, so the decision to use should be based on the necessity for treatment during lactation. There have been reports of erectile dysfunction during the use of this medication, so it is advisable to consult a doctor if related symptoms arise.

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

This medication should be stored in a tightly sealed container to prevent air exposure and kept at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the medication's effectiveness over time.

Appearance

Hard capsule filled with white to grayish-white powder, upper part yellow, lower part light yellow.

Package unit

300 capsules/bottle, 30 capsules/bottle