Rivantil Tablet 20 mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered with food. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose 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 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. 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 for the treatment of acute deep vein thrombosis and pulmonary embolism is 15 mg twice daily for the first 3 weeks. The recommended maintenance dose for subsequent treatment and the recommended dose for reducing the risk of recurrence are 20 mg once daily. After completion of treatment (at least 6 months), the recommended dose for extended administration to reduce the risk of recurrence is 10mg once daily. The duration and dose of treatment should be determined after an individual assessment of the risk of recurrence versus the risk of bleeding. 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 administration for 6 months or longer: 10mg once daily, 10mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg during the subsequent treatment period. Prevention of venous thromboembolism in adult patients who have undergone major orthopedic surgery of the lower limbs (knee or hip replacement): The recommended dose is 10 mg once daily. The initial dose should be started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of administration depends on each patient's individual risk; however, a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. If a dose is missed: Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at one time. From the following day, continue taking 15 mg twice daily. 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. Switching from a vitamin K antagonist to this medicine: 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. 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. Switching from this medicine to a vitamin K antagonist: Patients switching from this medicine to a vitamin K antagonist should receive 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 a dose of the vitamin K antagonist based on INR testing. In patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing must not be performed until 24 hours after taking this medicine. If this medicine is discontinued, INR testing may be performed 24 hours after the last dose. Switching from a parenteral anticoagulant to this medicine: 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). Switching from this medicine to a parenteral anticoagulant: Discontinue this medicine and start administration of the parenteral anticoagulant at the time the next dose of this medicine would have been due. 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 less than 15 mL/min, as there is no clinical experience in this population. 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. Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism: No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance of 15-29 mL/min. Prevention of venous thromboembolism in adult patients who have undergone 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). For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as 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 correctly positioned, and flush the tube with water after administration.

This medication prevents or treats clot formation by inhibiting blood coagulation. During treatment, bleeding may occur, so if bleeding symptoms appear, you must immediately inform your doctor. Pay special attention to signs of bleeding, such as headaches, dizziness, nosebleeds, gum bleeding, hematuria, and black stools. This medication should not be used in patients at high risk of bleeding, and caution is required in patients with severe liver or kidney dysfunction. Pregnant or breastfeeding women should not take this medication, and women planning to become pregnant must consult with a doctor. This medication cannot be used in patients with certain genetic disorders. Taking it with other anticoagulants may increase the risk of bleeding, so you must inform your doctor about all medications you are taking. Notify your doctor before undergoing any surgical or invasive procedures while on this medication, as it may be necessary to discontinue it. Elderly patients or those with impaired kidney function may have a higher risk of bleeding and require additional caution. Overdosing can increase the risk of bleeding, so it is essential to adhere strictly to the prescribed dosage, and if any unusual symptoms occur, seek medical attention immediately. Dizziness or drowsiness may occur when driving or operating machinery, so caution is advised. Regular blood tests to monitor for bleeding and anemia symptoms are recommended while on this medication. If severe skin rash or allergic reactions occur, discontinue the medication immediately and consult your doctor. There are drugs that interact with this medication, so inform healthcare professionals if you are taking other medications.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is also important to maintain a storage temperature between 1 degree and 30 degrees Celsius to ensure the medication's effectiveness.

Appearance

Brownish red round film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)