Rivaroxaban 2.5 mg Tablet (Rivaroxaban)

Adult dose

This medicine may be administered without regard to 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 coadministered with aspirin or with aspirin and clopidogrel The recommended dose of this medicine is 2.5mg twice daily. Patients should take this medicine together with aspirin 75-100mg once daily, or aspirin 75-100mg once daily and clopidogrel 75mg. Treatment for at least 24 months is recommended. Because 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 at 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 regular assessment of the individual patient's condition, taking into account the risk of bleeding compared with the risk of thrombotic events. During treatment with this medicine, for patients who experience an acute thrombotic event or undergo a vascular procedure and require dual antiplatelet therapy, the decision to continue this medicine at 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 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 The INR value will be falsely elevated after taking this medicine, 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 when switching to another anticoagulant. Note that this medicine may affect the increase in 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 based on INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, INR should not be tested until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR may be tested 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine For patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the time of the next scheduled dose of the parenteral agent (e.g., low molecular weight heparin), or when a continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 4) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start the parenteral anticoagulant at the time of the next scheduled dose of this medicine. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment with creatinine clearance of 50-80 mL/min. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance below 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 coadministered 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 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 are unable to swallow the tablet, 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 used to prevent or treat blood clots by inhibiting blood coagulation. While taking this medication, there is a risk of bleeding, so patients should carefully monitor for symptoms and signs of bleeding. If serious bleeding occurs, the medication should be stopped immediately, and healthcare professionals should be consulted. This medication should not be administered to patients with certain diseases or conditions. For instance, individuals allergic to any component of this medication, those with severe bleeding, severely impaired liver function, or who are pregnant or breastfeeding should not take this medication. Patients with a history of gastrointestinal ulcers, intracranial hemorrhages, spinal or cerebral vascular abnormalities, recent brain or spinal surgeries, or high-risk malignancies for bleeding should also refrain from using this medication. Caution should be taken when co-administering with other anticoagulants or specific antifungal medications, as the risk of bleeding may greatly increase. Patients with renal impairment, those with diseases that increase the risk of bleeding, or those taking medications that affect hemostasis should use this medication cautiously and monitor closely for symptoms of bleeding. This medication may cause various adverse reactions, the most common being bleeding, with anemia, dyspepsia, headache, and dizziness also possible. In severe cases, skin rash, allergic reactions, hepatic function abnormalities, and heart problems may occur, necessitating immediate consultation with healthcare professionals upon symptom onset. Elderly individuals may experience increased plasma concentrations; although dosage adjustments are generally not needed, the risk of bleeding may increase, so caution is warranted. Women who are pregnant or breastfeeding should not take this medication, and women planning to become pregnant should consult a physician before use. Overdose significantly increases the risk of bleeding, so patients should adhere to the prescribed dosages and contact a healthcare facility immediately in cases of overdose. Caution should be exercised when driving or operating machinery while taking this medication, especially if symptoms of drowsiness or dizziness occur. Finally, this medication may interact with other drugs, so patients should inform healthcare professionals of any other medications they are taking, and they should not stop or change their medications without consulting their doctor.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius, which helps maintain the effectiveness of the medication.

Appearance

Bright yellow round film-coated tablet

Package unit

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