Exetidine Capsule 150 mg (Nizatidine)

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer nizatidine 300mg 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. 2. Prevention of recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, administer 150mg 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 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. Dose adjustment in 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 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.

This medication should not be administered to certain patients. Patients with a history of allergy or hypersensitivity to this drug or other H2-receptor antagonists should not use it. Additionally, this medication contains lactose, so it should not be administered to patients with a genetic condition that prevents lactose digestion. Caution is also needed for certain patients when using this medication. Patients with a history of hypersensitivity to drugs, poor liver function, or impaired kidney function should use this drug with caution. In particular cases of reduced kidney function, the dose may need to be reduced or the dosing interval extended. This medication contains a coloring agent known as Yellow No. 5, so individuals with allergies or hypersensitivity to this component should take care. Rarely, during the use of this medication, severe allergic reactions such as skin rash, itching, difficulty breathing, or anaphylaxis may occur. If such symptoms arise, discontinue use immediately and consult a healthcare professional. Blood-related abnormalities such as anemia, leukopenia, and thrombocytopenia have been reported. If any abnormal symptoms appear, discontinue the medication. Gastrointestinal symptoms may include constipation, diarrhea, dry mouth, and nausea. Impaired liver function can also occur, potentially leading to elevated liver enzyme levels, hepatitis, or jaundice, so patients should monitor their liver health. Central nervous system symptoms may include confusion, headaches, drowsiness, dizziness, and weakness, with rare reports of seizures. Cardiac-related symptoms may include transient arrhythmia. In women, gynecomastia may occur rarely, and in men, reports of erectile dysfunction or decreased libido have been noted. Dermatological reactions may include sweating, urticaria, rash, dermatitis, and rarely vasculitis. Other conditions such as asymptomatic hyperuricemia unrelated to gout, fever, chest pain, muscle pain, rhinitis, pharyngitis, and cough have also been reported. This medication may mask symptoms of gastric cancer, so it should only be used after confirming that it is not gastric cancer. As it is mainly excreted through the kidneys, dosage adjustments may be necessary for patients with reduced kidney function. It is advisable to use the minimum dosage while confirming therapeutic efficacy, and if there is no improvement, switching to another medication is recommended. There is insufficient pharmacokinetic data for patients with liver or kidney disease, but in patients with impaired liver function, it may be administered at standard dosages. The potential for interactions with other specific drugs is low; however, when used in combination with high doses of aspirin, some drug concentrations may increase. Safety has not been established for pregnant or breastfeeding women, and it should only be used when necessary. In particular, breastfeeding women should be cautious as the drug may pass into breast milk. Safety in children has not been sufficiently established, and older adults are at a higher risk of kidney function decline, so kidney function tests are necessary before administration and regular monitoring during treatment. This drug may affect the results of certain clinical tests, so consider this during testing. In the case of overdose, symptoms may include vomiting, diarrhea, and increased salivation, and treatment may be necessary to remove the drug if needed. Studies on long-term high-dose administration indicate a low risk of carcinogenic effects, but caution is advised due to possible changes in the liver. When administered during pregnancy, the effects on the fetus are uncertain, so careful consideration must be given to the risks versus benefits, and decisions regarding drug administration and breastfeeding during lactation should be made cautiously. Erectile dysfunction has been reported during the use of this medication, so consulting a healthcare professional if related symptoms occur is advisable.

• Rash
• itching
• bronchial asthma
• laryngeal edema
• anaphylaxis symptoms
• anemia
• leukopenia
• increased neutrophils
• thrombocytopenic purpura
• constipation

This medication should be stored in a tightly sealed container to prevent air exposure and is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy for a longer period.

Appearance

[For Domestic Use]: Hard capsule filled with a white to almost white powder, with a reddish-brown upper part and a yellow lower part. [For Export]: Hard capsule with a whitish powder, opaque reddish-brown upper part, and yellow opaque lower part.

Package unit

[For Domestic Use] 30 capsules/bottle, 300 capsules/bottle [For Export] 30 capsules (10 capsules/PTP×3), 60 capsules (10 capsules/PTP×6), 100 capsules (10 capsules/PTP×10)