Neuroxaban Tablet 2.5 mg (Rivaroxaban)

Adult dose

This medicine may be taken with or without food. 1. Adults 1) Reduction in the incidence of atherothrombotic events (death due to cardiovascular causes, myocardial infarction) in patients who have experienced acute coronary syndrome with elevated cardiac biomarkers, when administered in combination with aspirin or with aspirin and clopidogrel The recommended dose of this medicine is 2.5mg twice daily. Patients should take aspirin 75-100mg once daily, or aspirin 75-100mg once daily and clopidogrel 75mg, together with this medicine. Treatment for at least 24 months is recommended. Because patients who have experienced acute coronary syndrome remain at risk of cardiovascular symptoms, extending the duration of treatment may be beneficial. Treatment with this medicine 2.5mg should be initiated as soon as possible after the acute coronary syndrome event has stabilized (including revascularization). Treatment may be initiated as early as 24 hours after hospitalization, once parenteral anticoagulant therapy has been appropriately discontinued. 2) Coronary artery disease (CAD) or peripheral artery disease (PAD) The recommended dose of this medicine is 2.5mg twice daily, and aspirin 75-100mg once daily should be taken together with this medicine. The duration of treatment with this medicine should be determined by regularly assessing the condition of each patient and considering the risk of bleeding relative to the risk of thrombotic events. During treatment with this medicine, for patients who experience an acute thrombotic event or undergo a vascular procedure, and for patients requiring dual antiplatelet therapy, the decision to continue this medicine 2.5mg twice daily should be assessed according to the antiplatelet therapy and the type of thrombotic event or vascular procedure. The efficacy and safety of this medicine administered with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Concomitant use of this medicine with dual antiplatelet therapy has not been studied in patients with coronary artery disease or peripheral artery disease. 3) If you miss a dose of this medicine If you miss a dose of this medicine, continue taking the recommended dose of 2.5mg at the next scheduled dosing time. Do not take twice the recommended daily dose to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine After taking this medicine, INR values will be falsely elevated, regardless of the dose. INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used for this purpose. 2) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this medicine may affect INR elevation. Patients switching from this medicine to a vitamin K antagonist should take the vitamin K antagonist concomitantly until INR≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer a dose based on INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, INR should not be measured until 24 hours after taking this medicine. Once this medicine has been discontinued, INR may be measured 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine For patients receiving a parenteral anticoagulant, initiate this medicine 0~2 hours before the time of the next scheduled parenteral dose (e.g., low molecular weight heparin), or when discontinuing a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 4) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and initiate the parenteral anticoagulant at the time of the next scheduled dose of this medicine. 3. Patients with renal impairment No dose adjustment is required in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Use of this medicine is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min, because there is no clinical experience in these patients. 1) Reduction in the incidence of atherothrombotic events (death due to cardiovascular causes, myocardial infarction) in patients who have experienced acute coronary syndrome with elevated cardiac biomarkers, when administered in combination with aspirin or with aspirin and clopidogrel No dose adjustment is required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood levels of this medicine are significantly increased; therefore, this medicine should be administered with caution. 4. Patients with hepatic impairment Avoid administering this medicine to patients with liver disease associated with coagulopathy and to patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 5. For patients who cannot swallow tablets, immediately before use, this medicine may be crushed and mixed with water or a beverage such as applesauce for oral administration. This medicine may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this medicine through a gastrointestinal tube, confirm that the tube is properly positioned, and flush the tube with water after administration.

This medication is an anticoagulant that prevents clot formation. During treatment, signs of bleeding should be carefully observed, and it should be used with caution in patients at high risk of bleeding. If severe bleeding develops, discontinue use immediately and take appropriate action as directed by a physician. This medication should not be used in certain patients, such as those with severe bleeding, liver disease, pregnant or breastfeeding women. Additionally, patients with genetic issues such as lactose intolerance should also avoid this medication. Patients with a history of gastrointestinal ulcers, cerebral hemorrhage, vascular abnormalities, or recent surgery, who are at high risk of bleeding, should use this medication cautiously. Caution is required when combined with other anticoagulants or certain antifungal agents due to an increased risk of bleeding. Patients with impaired kidney function or conditions that increase the risk of bleeding should also exercise caution while taking this medication. Various side effects such as bleeding, anemia, gastrointestinal symptoms, skin rash can occur, so any abnormal symptoms should be reported to medical personnel immediately. It is especially important to check blood tests when symptoms of bleeding or anemia are present. Furthermore, this medication should be discontinued for a certain period before surgery or invasive procedures, and after the procedure, dosing should be resumed according to the physician's instructions. Pregnant or breastfeeding women should not use this medication, and women of childbearing age must practice contraception during treatment. Elderly patients may have a higher risk of bleeding; however, no special dose adjustments are necessary. Overdosage of this medication can increase the risk of bleeding, so it is essential to adhere strictly to the prescribed dosage, and in case of overdose, immediate evaluation and treatment by medical personnel are required. Caution should be exercised while driving or operating machinery as drowsiness or fainting might occur.

• Bleeding
• anemia
• thrombocytosis
• tachycardia
• ocular bleeding
• gingival bleeding
• gastrointestinal bleeding
• abdominal pain
• digestive discomfort
• nausea

This medication should be stored in a tightly closed container to prevent air or moisture from entering and should be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness over time.

Appearance

Bright yellow round film-coated tablets

Package unit

30 tablets/bottle