Donggwang Nizatidine Capsule 150mg

Adult dose

1. Treatment of active gastric and 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 recurrence of duodenal ulcers 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: 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. Dose 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 creatinine clearance reduced to below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dose should also be reduced according to the degree of renal impairment in these patients.

This drug should not be used in patients with hypersensitivity to H2-receptor antagonists. Caution should be exercised when using in patients who have had allergic reactions to the drug or have poor liver or kidney function. In particular, patients with reduced kidney function may require reduced dosing or increased dosing intervals due to the drug persisting in the body for a longer time. This drug contains a colorant called Yellow No. 5, and those allergic to this component should use it cautiously. Rarely, serious allergic reactions such as skin rashes, itching, breathing difficulties, or anaphylaxis may occur; if any of these symptoms are present, administration should be stopped immediately. Blood abnormalities can manifest as symptoms of anemia, leukopenia, and thrombocytopenia; any unusual symptoms should be discussed with a physician. Gastrointestinal disturbances may occur, including constipation, diarrhea, dry mouth, and nausea. There is a potential for liver dysfunction; caution should be observed if symptoms of hepatitis or jaundice arise. Neurological symptoms such as confusion, headache, drowsiness, and dizziness can occur rarely. Transient tachycardia may occur. In women, breast enlargement has been reported infrequently, and in men, erectile dysfunction or decreased libido may occur. Skin-related adverse reactions, including rashes, hives, and sweating, may also be seen. Hyperuricemia can occur; therefore, patients with gout should be careful. This medication may mask symptoms of gastric cancer; thus, it should only be used after confirming it is not a malignant condition. Patients with poor kidney function require dose adjustments, and regular blood tests along with liver and kidney function tests should be performed during treatment. Women who are pregnant or breastfeeding should consult a doctor before taking this drug, as its effects on the fetus or newborn are not well established. Safety and effectiveness in children have not been established, hence its use is not recommended in this population. Elderly patients commonly exhibit reduced kidney function; therefore, kidney function tests should be conducted before administration, and careful monitoring should continue during treatment. In case of overdose, symptoms such as vomiting or diarrhea may occur, and appropriate treatment should be received at a hospital if necessary.

• 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 ingress and kept at a temperature between 1 degree and 30 degrees Celsius. Proper storage can help maintain the drug's effectiveness.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle, 300 capsules/bottle