Rivaroxaban 2.5 mg Tablet (Rivaroxaban)

Adult dose

This medicine may be administered 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 accompanied by 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. Since the risk of cardiovascular symptoms persists in patients who have experienced acute coronary syndrome, 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 and should be started when 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 individual patient, taking into account the risk of bleeding compared with the risk of thrombotic events. During treatment with this medicine, patients who experience an acute thrombotic event or undergo a vascular procedure, and patients who require dual antiplatelet therapy, should be evaluated for whether to continue this medicine 2.5mg twice daily, according to the antiplatelet therapy and the type of thrombotic event or vascular procedure. The efficacy and safety of coadministration of this medicine with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Coadministration of this medicine with dual antiplatelet therapy has not been studied in patients with coronary artery disease or peripheral artery disease. 3) If you forget to take this medicine If you forget to take this medicine, continue taking the recommended dose of 2.5mg at the next scheduled dosing time. The daily dose should not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine Regardless of the dose, the INR value will be falsely elevated after taking this medicine. 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 the elevation of INR. Patients switching from this medicine to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until INR≥2.0. During the first 2 days after the switch, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, INR testing should not be performed until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR testing can be performed 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine In patients receiving a parenteral anticoagulant, initiate this medicine 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low-molecular-weight heparin), or at the time of discontinuation of a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 4) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start administration of the parenteral anticoagulant at the time of the next dose of this medicine. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment with a creatinine clearance of 50-80 mL/min. Administration of this medicine is not recommended in patients with severe renal impairment with a creatinine clearance of less than 15 mL/min, as 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 accompanied by elevated cardiac biomarkers, when administered in combination with aspirin or with aspirin and clopidogrel No dose adjustment is necessary 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 the blood concentration of this medicine increased significantly; 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, this medicine may be crushed immediately before use, mixed with a liquid such as water or applesauce, and administered orally. 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 the blood from clotting and the formation of thrombi. Bleeding may occur during treatment, so signs of bleeding should be closely monitored. If severe bleeding occurs, discontinue use immediately and consult a healthcare professional. Patients with a known allergy to this medication, those with existing bleeding, patients with significantly impaired liver function, pregnant or breastfeeding women should not take this medication. Moreover, patients with lactose intolerance should avoid this medication. Patients with a high risk of bleeding, such as those with a history of gastrointestinal ulcers, cerebral hemorrhage, vascular abnormalities, or recent brain or spinal surgery, should also avoid this medication. Precautions should be taken when using this drug in conjunction with other anticoagulants or certain antifungal agents as it may increase the risk of bleeding. This medication should be used cautiously in patients with impaired renal function or those with conditions that increase the risk of bleeding. Inform healthcare professionals immediately if bleeding symptoms or anemia symptoms occur, and blood tests may be performed to confirm any bleeding. This medication can affect blood coagulation test results, so this should be considered during testing. Pregnant women must ensure contraception to avoid fetal effects, and it is advisable for breastfeeding women to avoid this medication. Elderly patients may experience increased drug concentrations due to decreased renal function; however, no specific dosage adjustment is needed. Safety and effectiveness in children and adolescents under 18 years of age have not been established, thus its use is not recommended. Overdosage increases the risk of bleeding, so adherence to the prescribed dosage should be strictly maintained, and if overdose is suspected, seek medical attention promptly. Caution is advised when driving or operating machinery as drowsiness or fainting may occur; be careful if such symptoms are present. If serious skin reactions or allergic symptoms occur while taking this medication, discontinue use immediately and consult a physician.

• Hemorrhage
• anemia
• thrombocytosis
• tachycardia
• ocular hemorrhage
• gingival bleeding
• gastrointestinal bleeding
• stomach pain
• abdominal pain
• dyspepsia

This medication should be stored in a well-closed container to prevent exposure to air or moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

10 tablets/PTP [30 tablets (10 tablets/PTP packaging x 3)], 3 PTPs/box