Nizatine Capsule (Nizatidine)

Adult dose

1. Treatment of active gastric or duodenal ulcers Adults: Administer 300mg of nizatidine once daily at bedtime, or 150mg twice daily, in the morning and evening, by mouth. 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 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. Dosage adjustment in patients with severe renal impairment The dose should be reduced and adjusted as follows in patients with renal impairment. Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer Creatinine clearance 20~50 ml/min: 150mg per day 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 dose 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 with hypersensitivity to H2-receptor antagonists. Patients with a history of drug allergic reactions or with liver or kidney function issues need to exercise caution when using this medication. In particular, patients with impaired kidney function may have elevated blood levels of this drug, necessitating a reduction in dosage or an increase in the dosing interval. If allergic symptoms such as rash, itching, or difficulty breathing occur during the use of this medication, it should be discontinued immediately. Blood abnormalities, such as anemia, leukopenia, and thrombocytopenia, have been reported, so treatment should be stopped if abnormal symptoms occur. Gastrointestinal disturbances may include constipation, diarrhea, dry mouth, and nausea, so caution should be exercised if these symptoms arise. Liver function abnormalities may occur, and severe liver damage such as hepatitis or jaundice has been rarely reported. Neurological side effects may also include mental confusion, headaches, drowsiness, and dizziness. Asymptomatic tachycardia may temporarily occur. Rarely, symptoms such as breast enlargement in women may occur, while men may experience erectile dysfunction or decreased libido. Skin reactions such as rashes, urticaria, sweating, and dermatitis may present. This medication may cause increased uric acid levels unrelated to gout or kidney stones, and other symptoms such as fever or myalgia have also been reported. It may mask symptoms of gastric cancer, so it should be administered only after malignancy is ruled out. Since it is mainly excreted through the kidneys, patients with severe kidney function impairment require dosage adjustments. If no therapeutic effect is observed, it is best to switch to another medication, and regular blood tests and liver and kidney function tests should be conducted. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of this medication. Breastfeeding women should use it only when necessary, as this drug may partially excrete into breast milk. Safety in children has not been established, and elderly patients commonly have reduced kidney function, so a kidney function test is needed before administration. In case of overdose, symptoms such as vomiting, diarrhea, and excessive salivation may occur, and professional treatment may be needed. Although no carcinogenicity or genotoxicity has been shown in various animal studies, high doses may affect the liver. The impact on the fetus during pregnancy is unclear, thus careful administration during pregnancy is necessary. Breastfeeding mothers should be cautious as this medication can be secreted into breast milk and affect the newborn. Erectile dysfunction has been reported during the use of this medication, so consult with healthcare providers if related symptoms arise.

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

This medication should be stored in a sealed container to prevent air and moisture from entering. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

A hard capsule with upper purple and lower light yellow color filled with white to grayish-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle