Rivaroxaban 10 mg (Rivaroxaban Tablet)

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered 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 coadministration 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. 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, is 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 following an individual assessment of the risk of recurrent deep vein thrombosis and pulmonary embolism compared with 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 6 months or more 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 during treatment. 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; 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, 2 tablets of 15 mg may be taken at one time. 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. The daily dose should 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 treatment and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) 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 treatment and start taking this medicine when the INR is ≤ 2.5. 2) Switching from this medicine to a vitamin K antagonist In patients switching from this medicine to a vitamin K antagonist, the vitamin K antagonist should be administered 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 test results. 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 administration 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 of the next scheduled dose of this medicine. 3. Patients with renal impairment No dose adjustment is required in patients with mild renal impairment with creatinine clearance of 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the plasma concentration of this medicine increased significantly; therefore, administer this medicine with caution. As there is no clinical experience in patients with severe renal impairment with creatinine clearance below 15 mL/min, 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 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 required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)

This drug prevents blood clotting and is used to prevent or treat thrombus formation. Therefore, there is a risk of bleeding, and careful observation for signs or symptoms of bleeding should be made. If severe bleeding occurs, this drug should be discontinued immediately, and professional treatment should be sought if necessary. This drug should not be used in certain patients. For example, patients who are allergic to this drug, those with severe bleeding already, those with severely impaired liver function, pregnant or breastfeeding women, and patients with lactose intolerance should not take it. Patients with recent gastrointestinal ulcers, history of intracranial hemorrhage, history of brain or spinal surgery, vascular malformations, or patients with high bleeding risk due to malignant tumors should also use this drug with great caution. When used in combination with other anticoagulants or certain antifungal agents, the risk of bleeding may increase, so consulting with a physician is mandatory. Patients with impaired renal function or bleeding risk conditions and those taking drugs that increase the risk of bleeding, such as non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors, also require careful monitoring and adjustment when using this drug. This drug can cause various adverse reactions, with the most common side effects being symptoms related to bleeding. Bleeding can occur in various areas, including skin, gastrointestinal tract, and urogenital system, and in severe cases could lead to anemia or myocardial ischemia. Rarely, serious side effects such as severe allergic reactions, liver function abnormalities, skin rashes, and agranulocytosis have been reported, so if such symptoms occur, immediate notification to healthcare personnel is necessary. This drug may pose risks to the fetus during pregnancy, so it should not be taken while pregnant, and women of childbearing potential must use contraception during treatment. Use of this drug is also not recommended for breastfeeding women. Elderly patients may experience higher blood concentrations of this drug, but generally, dosage adjustments are not required. However, increased risk of bleeding should be monitored carefully. Overdose may significantly increase the risk of bleeding, so it is essential to adhere to the prescribed doses and to contact a medical institution immediately in the event of an overdose. This drug can produce drowsiness or fainting which can affect driving or operating machinery, so if such symptoms appear, driving or hazardous work should be avoided. Finally, this drug may interact with other medications; therefore, if you are taking other medications, you must inform your physician or pharmacist. In particular, when used with CYP3A4 and P-glycoprotein inhibitors or inducers, other anticoagulants, or antiplatelet agents, the risk of bleeding may significantly increase, so caution is warranted.

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

This drug should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be at room temperature between 1 degree and 30 degrees, avoiding extremely hot or cold places.

Appearance

Bright red round film-coated tablet

Package unit

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