Bicidine 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 per dose 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 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 of longer-term use are not known. 3. Gastroesophageal reflux disease Adults: Administer 150mg per dose 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 per dose 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 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 impact of this dosage reduction in patients with renal impairment has not been evaluated.

This medication should not be used in patients who are hypersensitive to certain drugs, especially those sensitive to H2-receptor antagonists. It should be administered cautiously to patients with a history of drug allergies, liver dysfunction, and impaired renal function. In cases of renal impairment, the dosage should be reduced or the dosing interval increased. This medication contains a colorant called Yellow No. 5, so patients allergic to this ingredient should exercise caution. Skin rash, itching, bronchial asthma, and severe allergic reactions may rarely occur, and if such symptoms appear, use should be discontinued immediately. Blood-related anomalies such as anemia or changes in white blood cell count have been reported, and if these symptoms appear, the medication should be stopped and a doctor consulted. Gastrointestinal side effects may include constipation, diarrhea, dry mouth, and nausea. Liver function test values may increase, and symptoms of liver problems such as hepatitis and jaundice may occur rarely, so caution is necessary. Mental confusion, headache, drowsiness, and dizziness may occur rarely, and if severe, inform a doctor. Symptoms such as rapid heartbeat may occur, so abnormal symptoms should be closely monitored. In women, breast enlargement may occur rarely, and changes in sexual function have also been reported. Increased sweating, hives, and rashes may occur, so skin condition should be monitored closely. This medication may cause hyperuricemia, so patients with a history of gout or kidney stones should be cautious. This medication may mask symptoms of gastric cancer, so it should be administered only after confirming that it is not a malignant disease. Primarily excreted through the kidneys, patients with decreased renal function may need dosage adjustments, and regular blood tests and liver and kidney function tests should be conducted during treatment. Women who are pregnant or breastfeeding should only use this medication when the benefits of treatment outweigh the risks, as its safety has not been established. The safety in children has not been adequately confirmed, and elderly patients are at higher risk of reduced renal function, necessitating kidney function tests before administration. In cases of overdose, symptoms such as vomiting, diarrhea, and increased salivation may occur, and no specific antidote is available, so treatment and supportive care tailored to the symptoms are necessary. This medication has not shown evidence of carcinogenicity or genotoxicity even with prolonged high dosage; however, caution should be exercised as changes in liver function and weight loss may occur. If administered during pregnancy, it may affect the fetus, so it must be used only after consultation with a doctor, and caution is also warranted in breastfeeding as the drug may be excreted in breast milk. Finally, this medication may cause sexual dysfunction in some patients, so if any unusual symptoms arise, consulting with healthcare professionals is recommended.

• 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 and moisture from entering, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage maintains the effectiveness of the medication and prevents deterioration.

Appearance

A hard capsule with a purple upper part and a yellowish lower part containing a white to grayish white powder.

Package unit

30 capsules/bottle, 300 capsules/bottle