Actidine Capsule (Nizatidine)

Adult dose

1. Treatment of active gastric or 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 necessary. 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 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. Dose adjustment for patients with severe renal impairment The dose 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 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 dose reduction in patients with renal impairment has not been evaluated.

This medication should not be used in patients with a history of allergic reactions or hypersensitivity to specific drugs. It should be used with caution in patients with impaired liver or kidney function. In particular, if kidney function is decreased, the dosage should be reduced or the dosing interval increased. This medication contains a dye called Yellow No. 5; individuals allergic or hypersensitive to this component should be careful. If symptoms of allergic reactions such as skin rash, itching, or difficulty breathing occur while taking this medication, stop taking it immediately and consult a physician. Blood tests may show anemia or changes in white blood cell counts, so inform healthcare providers of any unusual symptoms. Some patients may experience gastrointestinal disturbances such as constipation, diarrhea, dry mouth, and nausea. There have been rare reports of elevated liver function tests, hepatitis, and jaundice, so it is advisable to regularly monitor liver health. Symptoms such as dizziness, drowsiness, headache, and mental confusion may occur; consult a physician if these symptoms are severe. Temporary rapid heart rate may occur. In rare cases, breast symptoms may occur in women, and erectile dysfunction or decreased libido has been reported in men. Skin reactions such as sweating, hives, rashes, and dermatitis may occur, so it is important to monitor skin condition closely. This medication may have a higher risk of side effects in elderly patients with reduced kidney function; hence monitoring kidney function is necessary to determine an appropriate dosage and to continually assess kidney status during treatment. Pregnant women or those who may become pregnant should use this medication only if the benefits of treatment outweigh the risks to the fetus. Breastfeeding mothers should use this medication only when absolutely necessary, as it may be secreted in breast milk; consult a physician regarding whether to discontinue breastfeeding. Safety in pediatric patients has not been established; thus, caution should be exercised when administering to children. If an overdose occurs, appropriate treatment such as inducing vomiting or gastric lavage should be performed, as drug removal via dialysis may be difficult. During treatment, serious conditions such as gastric cancer can be masked, so if symptoms do not improve, it is essential to consult healthcare providers. There are few drug interactions, but caution is needed as concomitant use with aspirin may increase blood levels of aspirin. This medication may affect clinical test results, so it is advisable to inform medical personnel about medication use when undergoing tests.

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

Store this medication in a tightly closed container to protect it from air and moisture, maintaining a storage temperature between 1°C and 30°C. This will help preserve the medication's effectiveness and prevent degradation.

Appearance

A hard capsule with a white to grayish-white powder filled, featuring a purple upper and light yellow lower part

Package unit

30 capsules/bottle, 300 capsules/bottle