Rivaroxaban 20 mg Tablet (Rivaroxaban)

Adult dose

This drug 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered with food. Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose of this drug 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 drug 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 have undergone percutaneous coronary intervention (PCI) with stent placement. (See '12. Clinical Trial Information') Treatment of deep vein thrombosis and pulmonary embolism / reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism: The recommended initial dose of this drug 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 completion of 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 following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism in relation to the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence, days 1-21: 15mg twice daily, total daily dose 30mg Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence, from day 22: 20mg once daily, total daily dose 20mg Reduction in the risk of recurrence of deep vein thrombosis or pulmonary embolism, after at least 6 months of treatment: 10mg once daily, total daily dose 10mg The maximum daily dose of this drug 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 undergoing major orthopedic surgery of the lower limbs (knee or hip replacement): The recommended dose of this drug is 10 mg once daily. The first dose should be started 6~10 hours after surgery, once hemostasis has been established. 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. If you miss a dose of this drug, take the missed dose as follows. Patients taking 15 mg twice daily: Take this drug immediately; in this case, two 15 mg tablets may be taken at one time. Starting the next day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the next day, continue taking 1 tablet once daily. The daily dose should not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this drug, reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: Discontinue vitamin K antagonist therapy and start taking this drug when the International Normalized Ratio (INR) is ≤ 3.0. Switching from a vitamin K antagonist to this drug, treatment of deep vein thrombosis and pulmonary embolism / reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism: Discontinue vitamin K antagonist therapy and start taking this drug when the INR is ≤ 2.5. Regardless of the dose, INR values will be falsely elevated after taking this drug. INR is not suitable for measuring the anticoagulant activity of this drug and should not be used. Inadequate anticoagulation may occur while switching from this drug to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously when switching to another anticoagulant. Note that this drug may affect the increase in INR. Patients switching from this drug to a vitamin K antagonist should receive both drugs 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 drug concomitantly with a vitamin K antagonist, INR testing should not be performed until 24 hours after taking this drug. Once this drug is discontinued, INR testing may be performed 24 hours after the last dose. In patients receiving a parenteral anticoagulant, start this drug 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). Discontinue this drug and start the parenteral anticoagulant at the time the next dose of this drug would have been due. No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that plasma concentrations of this drug increased significantly; therefore, this drug should be administered with caution. Use of this drug is not recommended in patients with severe renal impairment and creatinine clearance less than 15 mL/min because there is no clinical experience in these patients. Reduction in 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 in 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). Avoid administration of this drug 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 drug and increased risk of bleeding may occur in these patients. For patients who cannot swallow tablets, this drug may be crushed immediately before use, mixed with water or a beverage such as applesauce, and administered orally. This drug may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this drug through a gastrointestinal tube, confirm that the tube is correctly positioned and flush the tube with water after administration.

This drug is used to prevent or treat thrombosis by inhibiting blood clotting. However, there is a risk of bleeding during the treatment, so signs and symptoms of bleeding should be carefully monitored. If severe bleeding occurs, discontinue the medication immediately and consult a healthcare professional. This medication should not be administered to certain patients, such as those with severe bleeding, liver disease, pregnant or breastfeeding women, and patients with lactose intolerance. Additionally, patients with a recent history of gastrointestinal ulcers, intracranial hemorrhage, vascular anomalies, malignant tumors, and other conditions with a high risk of bleeding should also avoid this medication. Caution is needed when used with other anticoagulants or certain antifungal and antiplatelet agents as the risk of bleeding may increase. In patients with impaired kidney function or diseases with a high risk of bleeding, the medication should be administered cautiously, weighing the risks of bleeding against the therapeutic benefits. In addition to bleeding, various side effects such as anemia, indigestion, skin rashes, liver dysfunction may occur, and any unusual symptoms should be promptly reported to a healthcare professional. If severe skin rashes, mucosal ulcers, or high fever occur, the medication should be discontinued immediately and medical advice sought. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential must use contraception while taking it. Elderly patients or those with reduced kidney function may have elevated blood levels of this medication, increasing the risk of bleeding, but dose adjustment is usually not necessary. Safety and efficacy have not been established in children or adolescents under 18 years of age, and it is not recommended. In cases of overdose, the risk of bleeding significantly increases, so the prescribed dosage must be strictly followed, and immediate medical assistance should be sought if overdose is suspected. Caution is needed when driving or operating machinery; if drowsiness or fainting occurs after taking the medication, driving or operating machinery should be avoided. Before any surgical or invasive procedures, the medication should be discontinued for a certain period, and the timing of re-administration should be determined based on the risks and conditions of bleeding after the procedure. Abruptly stopping the medication may increase the risk of thrombosis, so it should not be stopped arbitrarily unless replaced with another anticoagulant. Regular monitoring of bleeding symptoms and blood tests is essential during the course of treatment.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

Brownish-red round film-coated tablet

Package unit

7 tablets/PTP, 30 tablets/PTP [(10 tablets/PTP packaging x 3)], 100 tablets/PTP [(10 tablets/PTP packaging x 10)]