Rivacor Tablet 20 mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered without regard to meals, 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 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') 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 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 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 recurrence of 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 during the subsequent treatment period. 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 the individual 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. 4) If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ①Patients 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. ②Patients 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 ①Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Treatment with the vitamin K antagonist should be discontinued, and this medicine should be started when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. ②Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Treatment with the vitamin K antagonist should be discontinued, and this medicine should be started when the INR is ≤ 2.5. The INR value will be falsely elevated after taking this medicine, regardless of the dose. INR is not appropriate for measuring the anticoagulant activity of this medicine and should not be used. 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. It should be noted 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, the standard dose of the vitamin K antagonist should be administered, followed by a dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be tested until 24 hours after taking this medicine. Once this medicine is discontinued, INR may be tested 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 with 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. Use of this medicine is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min because there is no clinical experience in these patients. 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 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). 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 a drink such as water or 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 medication is used to prevent or treat blood clots by inhibiting blood coagulation. During the use of this medication, bleeding may occur; therefore, if any signs of bleeding appear, immediate notification of healthcare professionals is required. In particular, if severe bleeding occurs, discontinuation of this medication is necessary, and appropriate treatment must be followed as per the physician's direction. This medication should not be administered to patients with certain diseases or those at high risk of bleeding. For example, individuals who are allergic to this medication or those who are pregnant or breastfeeding, patients with liver or blood coagulation problems, or those who have recently experienced significant bleeding or undergone surgery should not use this medication. Additionally, patients with genetic metabolic disorders such as lactose intolerance should not take this medication. Patients with impaired kidney function or conditions that pose a high risk of bleeding should exercise particular caution when using this medication. Caution is also advised when this medication is taken with other drugs that may increase the risk of bleeding, and the decision regarding its administration should be made according to the physician's judgment. Side effects that may occur while taking this medication include bleeding, anemia, dyspepsia, headache, rash, etc., and in severe cases, allergic reactions or skin conditions may arise. If any bleeding symptoms or adverse reactions occur, immediate consultation with healthcare professionals is required. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing potential must practice contraception while taking this medication. Elderly patients may experience increased concentrations of this medication due to decreased kidney function; however, generally, dosage adjustments are not required, but the risk of bleeding may increase. This medication can interact with other anticoagulants, antifungals, antibiotics, NSAIDs, etc., so if other medications are being taken, it is crucial to inform a doctor or pharmacist. Before surgery or invasive procedures, this medication should be discontinued for a certain period, and after surgery, the timing of re-administration should be determined considering the risk of bleeding. Overdose may pose the risk of bleeding complications, so care must be taken not to exceed the recommended dosage, and immediate medical attention is required if any unusual symptoms appear. Caution must also be exercised when driving or operating machinery, as drowsiness or dizziness may occur.

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

This medication must be stored in a tightly sealed container to protect it from air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Biconvex round film-coated tablet in dark red color

Package unit

100 tablets/box [10 tablets/PTPX10], 30 tablets/box [10 tablets/PTPX3]