Janide Capsule (Nizatidine)

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. 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 continue 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 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. Dosage adjustment for patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Creatinine clearance Dose Active duodenal ulcer Gastroesophageal reflux disease (GERD) Benign gastric ulcer 20~50 ml/min 150mg daily < 20 ml/min 150mg every other day Maintenance therapy 20~50 ml/min 150mg every other day < 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 dose should also be reduced according to the degree of renal impairment in these patients. The clinical effects of this dose reduction in patients with renal impairment have not been evaluated.

This medication should not be used in patients with an allergy to specific drugs. It should be avoided in cases where there has been a hypersensitivity reaction to similar types of drugs. Patients with a history of allergic reactions or problems with liver or kidney function should exercise greater caution when using this medication. Patients with impaired kidney function may need to reduce the dose or extend the intervals between doses as the drug may remain in the body longer. If allergic symptoms such as skin rash, itching, respiratory distress, or swelling of the face or neck occur while using this drug, usage should be stopped immediately. Additionally, symptoms such as anemia or abnormalities in blood cell counts may arise, and consultation with a physician is warranted if such symptoms occur. Gastrointestinal symptoms such as constipation, diarrhea, dry mouth, and nausea may occur, and there may be signs of liver dysfunction. If liver dysfunction is suspected, liver function tests should be performed. Rarely, neurological symptoms such as confusion, headache, drowsiness, and dizziness may occur, and rapid heart rate may be noted. In women, symptoms of breast enlargement may occur, and sexual dysfunction has been reported. There may be increased sweating or the occurrence of hives, rashes, and dermatitis on the skin, and rarely serious skin conditions such as vasculitis may appear. Other reported symptoms include increased uric acid levels not associated with gout, fever, chest pain, muscle pain, rhinitis, pharyngitis, and cough. This drug may mask symptoms of stomach cancer; therefore, it should be used only after confirming that it is not cancer. For patients with decreased kidney function, dose adjustments are necessary. Regular blood tests and liver and kidney function tests should be performed during treatment, and if no efficacy is observed, other treatments should be considered. Pregnant or breastfeeding women should only use this drug when absolutely necessary, as the safety of this medication is not certain; caution is needed as the drug may pass into breast milk during lactation. The safety and efficacy in children have not been adequately established, and elderly patients are more likely to have impaired kidney function, so kidney function tests should be conducted before administration, and their condition should be carefully monitored during treatment. This drug does not have significant interactions with other medications, but caution is needed when used concomitantly with high-dose aspirin. In case of overdose, symptoms such as vomiting, diarrhea, excessive salivation, and pupil constriction may occur; in such cases, emergency measures such as inducing vomiting or gastric lavage should be taken. Blood dialysis will not effectively remove this drug. Long-term high-dose use has shown a low possibility of cancer development in animal studies, but caution is warranted as it may affect the liver. Clinical trials have reported side effects such as erectile dysfunction with this medication; thus, if changes in sexual function occur, consulting a physician is advisable.

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

This medication should be stored in a sealed container to prevent air from entering and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness.

Appearance

A yellow capsule with a light yellow contents in the upper part and pale yellow in the lower part.

Package unit

30 capsules/bottle, 300 capsules/bottle