Tinijacapsule 150mg (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, by oral administration. 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 administration are not known. 3. Gastroesophageal reflux disease Adults: Administer 150mg per dose twice daily, in the morning and evening, by oral administration. Treatment may be continued for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Administer 150mg per dose twice daily, in the morning and evening, by oral administration for 2 weeks. 5. Dosage adjustment for patients with severe renal impairment The dosage 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 Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: Creatinine clearance < 20 ml/min, 150mg every other day Maintenance therapy: Creatinine clearance 20~50 ml/min, 150mg every other day Maintenance therapy: 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 dosage should also be reduced in these patients according to the degree of renal impairment. The clinical effects of this dosage reduction in patients with renal impairment have not been evaluated.

This drug is an H2-receptor antagonist that is used to treat gastrointestinal disorders by inhibiting gastric acid secretion. This drug should not be administered to patients who have experienced an allergic reaction to H2-receptor antagonists in the past, as these patients are at a higher risk of hypersensitivity reactions. Caution is required when using this drug in patients with a history of drug hypersensitivity or in those with liver or kidney function issues. Particularly, patients with reduced kidney function may retain the drug in their bodies longer, increasing the risk of side effects; therefore, the dosage should be reduced or the dosing interval increased. If symptoms of hypersensitivity such as rash, itching, dyspnea, or swelling occur during treatment, use should be discontinued immediately. Symptoms of blood abnormalities may include anemia, leukopenia, and thrombocytopenia, so if unusual symptoms arise, consultation with a physician is necessary. Gastrointestinal side effects may include constipation, diarrhea, dry mouth, and nausea. Liver function may be impaired; thus, if liver enzyme elevations or jaundice occur, medical personnel should be notified immediately. Rarely, neurological symptoms such as confusion, headache, drowsiness, and dizziness may occur, and cases of seizures have been reported, so caution is required. Various side effects have been reported, including cardiac arrhythmias, breast enlargement in women, sweating, skin rashes, and more. This drug is primarily excreted through the kidneys, so elderly patients or those with reduced kidney function should undergo kidney function tests, and dosage adjustments may be necessary. Women who are pregnant or breastfeeding should use this drug cautiously, as its safety has not been fully established. Safety in pediatric patients has not been sufficiently verified; therefore, use is not recommended. While this drug shows minimal interactions with other specific drugs, caution is advised when used in conjunction with high-dose aspirin, as blood salicylate levels may increase. In cases of overdose, symptoms such as vomiting, diarrhea, and pupillary constriction may occur; supportive treatment and clinical evaluation are necessary in emergency situations. Blood dialysis is not effective for the removal of this drug. This drug may mask the symptoms of gastric cancer, so it should be used after confirming that malignancy is not present. If no therapeutic effect is observed, it is advisable to switch to another treatment method, and during treatment, regular blood tests and liver/kidney function evaluations should be conducted.

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

This drug is sensitive to light; therefore, it should be stored in a container that blocks light. Additionally, it is important to store it at room temperature between 1 and 30 degrees Celsius to maintain its efficacy.

Appearance

A yellow hard capsule filled with crystalline contents of white to off-white color.

Package unit

30 capsules/bottle, 300 capsules/bottle