Huniznizatidine Capsule 150 mg

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Administer nizatidine 300mg once daily at bedtime, or 150mg per dose 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 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 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. 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 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 a creatinine clearance below 50mL/min. Based on pharmacokinetic data in patients with renal impairment, the dosage should also be reduced in such patients according to the degree of renal impairment.

This medication should not be used by certain patients. Individuals with a history of allergy to this medication or similar drugs should not take it. Additionally, patients with a history of allergic reactions to the drug or with liver or kidney function issues should use it with caution. Patients with impaired kidney function should reduce the dose or increase dosing intervals, as the drug concentration may remain in the body for a longer time. This medication contains a dye called Yellow No. 5, so individuals with allergies or sensitivities to this component should also be careful. Rarely, allergic reactions such as skin rash, itching, asthma, or laryngeal edema may occur; if any abnormal symptoms appear, the medication should be stopped immediately. It can affect blood, potentially showing anemia, leukopenia, or thrombocytopenic purpura, so monitor health closely. Gastrointestinal disturbances such as constipation, diarrhea, dry mouth, or nausea may occur, and liver function tests may show increases or lead to liver issues such as hepatitis and jaundice. Rarely, symptoms like mental confusion, headache, drowsiness, dizziness, and lethargy may occur, and seizures have been reported occasionally. Tachycardia may temporarily occur, and gynecomastia may rarely happen in women. Skin symptoms such as sweating, urticaria, rash, dermatitis, or vasculitis may occur, so monitor skin condition carefully. This medication is not related to gout or kidney stones but may cause hyperuricemia, and symptoms like fever, chest pain, myalgia, rhinitis, pharyngitis, and cough have been reported. It may mask symptoms of gastric cancer, hence verification to exclude malignant conditions is needed before use, and dosage adjustment is required if kidney function is moderately impaired or worse. Blood tests and liver and kidney function tests should be performed regularly during treatment to check for abnormalities, and another treatment should be considered if there is no effect. Since this medication is metabolized in the liver, patients with liver dysfunction should also use it with caution. Although interactions with other specific medications are minimal, when taken with high doses of aspirin, plasma concentrations of aspirin can increase. Pregnant or breastfeeding women should only take this medication when its safety is clearly confirmed for necessity, and nursing mothers should be careful as the drug may be excreted into breast milk. The safety and efficacy in pediatric patients have not been sufficiently established, and elderly patients often have reduced kidney function, requiring kidney function tests and dosage adjustments before use. This medication can affect certain clinical test results, so be mindful when interpreting test outcomes. In cases of overdose, symptoms such as vomiting, diarrhea, pinpoint pupils, and increased salivation may appear, necessitating treatment such as inducing vomiting, gastric lavage, or using adsorbents if required. It is important to note that this drug cannot be effectively removed by dialysis, so caution is warranted. There is no evidence of carcinogenicity with prolonged high-dose administration; however, changes were observed in the liver in some animal studies, warranting caution with long-term use. In animal studies during pregnancy, some fetal abnormalities were reported; however, clear effects on humans have not been confirmed, so prudent judgment is required during pregnancy. Nursing mothers should carefully consider the administration of the drug and breastfeeding due to its partial excretion into breast milk. Symptoms of erectile dysfunction have been reported during the use of this medication, so consulting a physician if such symptoms arise is advisable.

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

This medication is sensitive to light and should be stored in a container that does not allow light in. Additionally, it is important to maintain a temperature between 1 and 30 degrees Celsius while storing the medication to preserve its efficacy.

Appearance

A hard capsule filled with crystalline content that is white to grayish-white, with a yellow upper part and a light yellow lower part.

Package unit

30 capsules/bottle, 300 capsules/bottle