Rivaroxaban Tablet 20 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 15 mg once daily [10 mg 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') 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 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 for deep vein thrombosis or pulmonary embolism (at least 6 months), the recommended dose for extended treatment to reduce the risk of recurrence is 10 mg once daily. The duration of treatment and dose should be determined after an individual assessment of the risk of recurrence of 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 15 mg twice daily 30 mg From day 22 20 mg once daily 20 mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism After at least 6 months of treatment 10 mg once daily 10 mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter during the treatment period. 3) Prevention of venous thromboembolism in adult patients who have undergone 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 administered 6~10 hours after surgery, once hemostasis has been established. The duration of treatment depends on the individual patient's risk of venous thromboembolism based on the type of surgery; 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 one 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, the INR value 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 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 the vitamin K antagonist concomitantly until the INR is ≥2.0. For 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 the INR test results. However, in patients receiving this medicine together with a vitamin K antagonist, 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 For 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 when discontinuing a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 4) 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. 3. Patients with renal impairment 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 blood concentrations of this medicine increased significantly; therefore, this medicine should be administered with caution. There is no clinical experience in patients with severe renal impairment with creatinine clearance less than 15 mL/min; therefore, use 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 in 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 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). 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 cannot swallow tablets, Immediately before use, this medicine may be crushed and mixed with water or a drink 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 correctly positioned, and flush the tube with water after administration.

This medicine is used to prevent or treat the formation of blood clots by inhibiting blood coagulation. During the use of this medicine, bleeding may occur, so it is essential to always monitor for signs or symptoms of bleeding. In particular, if severe bleeding occurs, the use of this medicine should be discontinued immediately, and a doctor should be consulted. This medicine should not be administered to certain patients. For example, individuals allergic to any component of this medicine, those with ongoing serious bleeding, those with severely impaired liver function, pregnant or breastfeeding women, individuals with genetic issues such as lactose intolerance, and those with a recent history of gastrointestinal ulcers or intracranial hemorrhage should not take this medicine. Additionally, the risk of bleeding may significantly increase when taken in combination with other anticoagulants or certain antifungal agents, so consultation with a physician is imperative. Patients with impaired kidney function or conditions with a high risk of bleeding, as well as those taking medications that impact hemostasis, such as non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors, should use this medicine with caution and should monitor closely for any symptoms of bleeding. This medicine can cause various side effects, the most common being bleeding and anemia, while other reported side effects include dyspepsia, headache, dizziness, skin rash, and others. Pregnant or breastfeeding women should not take this medicine, and women of childbearing age should ensure contraception during treatment. Older adults may experience increased blood concentration due to impaired kidney function; however, dose adjustment is generally not necessary, although the risk of bleeding may increase. In cases of overdose, the risk of bleeding increases, so the dosage must not be exceeded without a doctor's direction, and if an overdose is suspected, medical attention should be sought immediately. Caution is required while driving or operating machinery during treatment, and if symptoms of drowsiness or fainting occur, driving should be avoided. Finally, if symptoms of bleeding or adverse reactions occur during the course of this medicine, appropriate evaluation and treatment should be sought immediately from healthcare personnel.

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

This medicine should be stored in a tightly closed container to protect it from air or moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius (room temperature).

Appearance

Round film-coated tablet of red color with a brown tint

Package unit

30 tablets/box [(10 tablets/PTP×3)], 100 tablets/box [(10 tablets/PTP×10)]