Rivaro 10 mg Tablets (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 15 mg once daily [10 mg once daily for 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 have undergone 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 recurrent 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 the 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 dose should be determined after an individual assessment of the risk of recurrent deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment period 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 recurrent 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 first dose should be started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of treatment depends on the individual patient's risk of venous thromboembolism according to the type of surgery; 5 weeks of treatment 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, 2 tablets of 15 mg may be taken at once. Starting the next day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the next day, continue taking 1 tablet once daily. 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 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 recurrent 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, the INR value will be falsely elevated after taking this medicine. The INR is not appropriate 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 increase in INR. Patients switching from this medicine to a vitamin K antagonist should receive both medicines 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 a dose based on 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 and creatinine clearance of 50-80 mL/min. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), plasma concentrations of this medicine increased significantly; therefore, administer this medicine with caution. Use of this medicine is not recommended in patients with severe renal impairment and creatinine clearance below 15 mL/min because there is no clinical experience in this population. 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 recurrent 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). 4. Patients with hepatic impairment Avoid administration of this medicine in patients with liver disease associated with coagulopathy and in 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. Patients who are unable to 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 feeding tube. Before administering this medicine through a feeding tube, confirm that the tube is properly positioned, and flush the tube with water after administration.

This drug is used to prevent or treat thrombus formation by thinning the blood. During treatment with this medication, careful monitoring for signs of bleeding is essential. It should be used with caution in patients at high risk of bleeding, and in cases of severe bleeding, discontinuation of the medication should be done immediately. It should not be used in patients with allergies to this medication, those with severe bleeding, patients with significantly impaired liver function, pregnant or breastfeeding women, or those with certain genetic lactase intolerance. Patients with a history of gastrointestinal ulcers, intracranial hemorrhage, spinal or brain surgery, or those with bleeding risk disorders should also avoid using this medication. When taken with other anticoagulants or certain antifungal agents, the risk of bleeding may significantly increase, thus avoiding or using with caution is advised. It should be used with increased caution in patients with renal impairment, bleeding risk disorders, or those taking medications that affect bleeding such as non-steroidal anti-inflammatory drugs or platelet inhibitors. This medication may cause side effects such as bleeding, anemia, gastrointestinal disturbances, skin rash, and liver dysfunction, so patients should consult medical personnel immediately if any unusual symptoms occur. Elderly patients or those with reduced kidney function may experience elevated blood concentration, increasing the risk of bleeding, so they should be monitored closely. Women who are pregnant or breastfeeding should not take this medication, and women planning to become pregnant should consult a physician. In case of overdose, the risk of bleeding increases, so dosage should be strictly adhered to, and if symptoms of bleeding occur, immediate medical attention is required. Caution is advised while driving or operating machinery, as drowsiness or dizziness may occur during treatment. Prior to any surgery or invasive procedures, it is essential to inform medical personnel about taking this medication, and discontinuation may be required for a certain period before any procedures. This medication may affect blood test results, so patients should inform medical personnel during tests.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to keep the medication at room temperature between 1 and 30 degrees Celsius, away from excessively hot or cold conditions.

Appearance

Pink round film-coated tablets

Package unit

5 tablets/box [5 tablets/PTP], 30 tablets/box [10 tablets/PTP x 3]