Rivacor Tablet 15 mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be taken with or without food, while 15 mg and 20 mg should be taken with food. 1. Adults 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose of this medicine is 20 mg once daily. The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) is 15 mg once daily. The maximum daily dose of this medicine is 20 mg. There is limited experience with concomitant administration of rivaroxaban 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] and a P2Y12 inhibitor for up to 12 months in patients with nonvalvular atrial fibrillation who underwent percutaneous coronary intervention (PCI) with stent placement. (See '12. Clinical Trial Information') 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended initial dose of this medicine for the treatment of acute deep vein thrombosis and pulmonary embolism is 15 mg twice daily for the first 3 weeks. Thereafter, the recommended maintenance dose for treatment of deep vein thrombosis and pulmonary embolism and the recommended dose for reducing the risk of recurrence are 20 mg once daily. After completing treatment (at least 6 months) for deep vein thrombosis or pulmonary embolism, the recommended dose for extended treatment to reduce the risk of recurrence is 10mg once daily. The duration of treatment and treatment dose should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Treatment duration Dosing frequency Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21 15mg twice daily 30mg From day 22 20mg once daily 20mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism After at least 6 months of treatment 10mg once daily 10mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. 3) Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement) The recommended dose of this medicine is 10 mg once daily. The initial dose should be started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of treatment depends on each patient's risk of venous thromboembolism according to the type of surgery; however, a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. 4) If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at once. From the following day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the following day, continue taking 1 tablet once daily. The daily dose must not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine ① Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist therapy and start taking this medicine when the International Normalized Ratio (INR) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Discontinue vitamin K antagonist therapy and start taking this medicine when the INR is ≤ 2.5. Regardless of the dose, INR values will be falsely elevated after taking this medicine. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medicine. 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 must be maintained continuously while 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 take the vitamin K antagonist concomitantly until the INR is ≥ 2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist according to INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this medicine. Once this medicine is discontinued, INR testing may be performed 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine In patients receiving a parenteral anticoagulant, start 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 the parenteral anticoagulant at the time the next dose of this medicine would have been due. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment with creatinine clearance of 50-80 mL/min. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), blood concentrations of this medicine were significantly increased; therefore, this medicine should be administered with caution. There is no clinical experience in patients with severe renal impairment with creatinine clearance below 15 mL/min; therefore, administration of this medicine is not recommended. 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) and severe renal impairment (creatinine clearance 15-29 mL/min) is 15 mg once daily. 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism / prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement) No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 5. 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 administer after flushing the tube with water.

This medication is used to prevent or treat blood clots by inhibiting blood coagulation. However, the risk of bleeding may increase while taking this medication, so signs of bleeding should be carefully observed at all times. If severe bleeding occurs, stop taking this medication immediately and consult a doctor. This medication should not be used in patients with certain diseases or conditions, such as those with severe bleeding, significant liver dysfunction, pregnant or breastfeeding individuals, and those with certain hereditary metabolic disorders. Additionally, patients who have undergone recent surgeries or have conditions that pose a high risk of bleeding, or who are taking other anticoagulants or certain antifungal medications, must consult with a doctor before using this medication. Caution is needed in patients with impaired kidney function or other diseases that increase the risk of bleeding when taking this medication, especially when combined with other drugs that may increase bleeding risk (such as non-steroidal anti-inflammatory drugs, platelet aggregation inhibitors). During treatment, it is important to regularly monitor for bleeding symptoms or signs of anemia, and to have regular blood tests as directed by a doctor. If bleeding is suspected, notify healthcare personnel immediately for appropriate action. It is advisable for pregnant or breastfeeding women to avoid taking this medication, and women of childbearing age should avoid pregnancy while taking this medication. Elderly patients may have an increased drug concentration in their blood due to reduced kidney function, but dosage adjustments are generally not necessary; however, the risk of bleeding may increase. The safety and efficacy of this medication in children or adolescents under 18 years have not been established, so it is not recommended for use in these populations. This medication may interact with other drugs, so be sure to inform your doctor or pharmacist of any other medications being taken. Overdose may significantly increase the risk of bleeding, so caution is required, and if overdose is suspected, contact a healthcare facility immediately. Symptoms such as drowsiness or dizziness may occur when driving or operating machinery, so caution should be exercised if such symptoms occur. If surgery or procedures are forthcoming, this medication may need to be discontinued; consult with a healthcare provider. If severe skin reactions or allergic symptoms occur during treatment with this medication, stop taking it immediately and seek medical attention.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. This helps maintain the drug's effectiveness over time.

Appearance

Brown, round, biconvex film-coated tablets

Package unit

100 tablets/box [10 tablets/PTPX10], 30 tablets/box [10 tablets/PTPX3]