Exatin Capsule 150 mg (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 needed. For active gastric ulcers, 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 for 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 Creatinine clearance may be reduced to less than 50mL/min in some older adults. Based on pharmacokinetic data in patients with renal impairment, the dose should also be reduced according to the degree of renal impairment in such patients. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

This drug should not be used in patients who have hypersensitivity to H2-receptor antagonists. Patients with a history of allergic reactions to the drug, or with liver or kidney impairments, should use it with caution, especially those with reduced kidney function, who may require dose reduction or increased dosing intervals. Rarely, this medication can cause skin rashes, itching, bronchial asthma, laryngeal edema, and severe allergic reactions, so immediate discontinuation should occur if these symptoms arise. Blood abnormalities may include anemia, changes in white blood cell counts, thrombocytopenia, etc., and any unusual symptoms should be consulted with a physician. Gastrointestinal side effects may include constipation, diarrhea, dry mouth, and nausea. Elevated liver function tests or liver damage symptoms such as hepatitis and jaundice have been reported rarely, so liver health should be monitored. Psychological side effects may include confusion, headache, drowsiness, dizziness, and rarely seizures. Some may experience transient asymptomatic ventricular tachycardia. In females, gynecomastia may rarely occur, while males have reported erectile dysfunction and decreased libido. Skin reactions may include sweating, urticaria, rash, dermatitis, and vasculitis. This drug may cause hyperuricemia unrelated to gout or nephrolithiasis, and fever, chest pain, myalgia, rhinitis, pharyngitis, and cough have been reported. It may mask symptoms of gastric cancer, so it should only be used after confirming that malignancy is absent, and consistent monitoring of blood, liver, and kidney function during treatment is required. This medication is primarily excreted by the kidneys, so patients with moderate or severe kidney impairment should have their doses reduced. Pregnant women or those who may become pregnant should only use this medication if the benefits outweigh the risks, as its effect on the fetus is not clearly established. Breastfeeding mothers should only use it when necessary, as it may be excreted in breast milk. Safety in pediatric patients has not been established, and seniors should be cautious of decreased kidney function; kidney function tests should be performed before administration and monitored during treatment. In case of overdose, symptoms may include vomiting, diarrhea, and pupillary constriction, which may require clinical examination, administration of activated charcoal, induction of vomiting, or gastric lavage. This drug is not effectively removed through hemodialysis, so prompt medical intervention is critical in case of overdose. This drug has relatively few interactions with other medications and does not significantly affect metabolism in the liver, so caution is reduced when used with common medications. Lastly, while there is no clear evidence of carcinogenicity or genotoxicity with long-term high-dose use, some changes and liver damage have been observed in animal studies, so caution is advised with prolonged use.

• 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 blocks light, at temperatures between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy for a longer period.

Appearance

A hard capsule with yellow upper and lower parts filled with crystalline white to whitish contents.

Package unit

30 capsules/bottle, 300 capsules/bottle