Zatidine Capsule 150 mg (Nizatidine)

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer nizatidine 300 mg once daily at bedtime, or 150 mg twice daily, in the morning and evening, orally. 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 recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, administer 150 mg 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 150 mg orally twice daily, in the morning and evening. Treatment may continue for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Administer 150 mg orally twice daily, in the morning and evening, for 2 weeks. 5. Dose adjustment in patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Creatinine clearance 20~50 ml/min: Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: 150 mg daily Creatinine clearance < 20 ml/min: Active duodenal ulcer, gastroesophageal reflux disease (GERD), benign gastric ulcer: 150 mg every other day Maintenance therapy Creatinine clearance 20~50 ml/min: 150 mg every other day Creatinine clearance < 20 ml/min: 150 mg 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 in these patients according to the degree of renal impairment. The clinical impact of such dose reductions in patients with renal impairment has not been evaluated.

This medication should not be used in patients who have had allergic reactions to this drug or similar drugs. Caution should be exercised in patients suspected of having allergic reactions and those with liver or kidney dysfunction. In particular, patients with weak kidney function should reduce dosage or adjust the dosing interval, as drug concentration may increase. If symptoms such as rash, itching, difficulty breathing, or swelling of the face or neck appear while using this medication, treatment should be stopped immediately. If there are symptoms of anemia, leukopenia, or thrombocytopenia due to possible blood abnormalities, the drug should be discontinued and a physician should be consulted. Gastrointestinal side effects such as constipation, diarrhea, dry mouth, and nausea may occasionally occur. Liver dysfunction may occur, so caution is necessary if liver function tests show increased liver enzyme levels, or symptoms of hepatitis or jaundice appear. Rarely, neurological symptoms such as confusion, headache, drowsiness, dizziness, and lassitude may occur, with reports of seizures. There may be temporary episodes of a rapid heartbeat. In women, breast enlargement may rarely occur, while men have reported erectile dysfunction or decreased libido. Skin symptoms such as sweating, rash, urticaria, dermatitis, and rarely vasculitis may occur. This drug may elevate uric acid levels, potentially leading to hyperuricemia unrelated to gout or kidney stones. This drug can mask symptoms of gastric cancer; therefore, it should be used only after confirming that there are no malignant diseases. As this drug is primarily excreted through the kidneys, patients with severe kidney dysfunction should have their dosage adjusted, and regular blood tests and monitoring of liver and kidney function during treatment are essential. Pregnant women or those who may become pregnant should use this medication only when the benefits surpass the risks, and lactating women should use it only when absolutely necessary. Safety in children has not been established, and elderly patients, who are likely to have decreased kidney function, should be carefully monitored before and during treatment. This drug may lead to false-positive results on certain clinical tests, so care must be taken when interpreting test results. In cases of overdose, symptoms such as vomiting, diarrhea, and increased saliva production may occur, and immediate consultation with healthcare professionals is recommended as special treatment may be necessary. This drug generally has few interactions with other medications, but caution is advised if taken with aspirin at high doses, as this may increase the concentration of some components.

• 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 can block light. It is best stored at room temperature between 1°C and 30°C to maintain its effectiveness and safety.

Appearance

A hard capsule with yellow upper and lower parts filled with crystalline content ranging from white to ivory.

Package unit

30 capsules/bottle, 300 capsules/bottle