Myeongin Rivaroxaban Tablet 20 mg

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 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 initial recommended 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 (at least 6 months) for deep vein thrombosis or pulmonary embolism, 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 of deep vein thrombosis and pulmonary embolism compared with the risk of bleeding. Treatment period Frequency of administration 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 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 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 started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of administration depends on each patient's risk of venous thromboembolism according to the type of surgery; however, a treatment period of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for those 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 1 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, International Normalized Ratio) 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, INR values 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 must be maintained continuously during a switch to another anticoagulant. Note that this medicine may affect the increase in INR. Patients switching from this medicine to a vitamin K antagonist should take 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 the dose of the vitamin K antagonist according to INR test results. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be measured until 24 hours after taking this medicine. Once this medicine is discontinued, INR may be measured 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 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 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 required in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), plasma concentrations of this medicine increased significantly; therefore, administer this medicine with caution. 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 these patients. 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 required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 4. Patients with hepatic impairment Avoid administration of this medicine 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 medicine and an increased risk of bleeding may occur in these patients. 5. Patients who cannot swallow tablets, Immediately before use, this medicine may be crushed and mixed with water or a beverage 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 medication is used to inhibit blood coagulation to prevent or treat thrombus formation. During treatment with this medicine, be vigilant for symptoms or signs of bleeding. If severe bleeding occurs, discontinue the medicine immediately and consult a doctor. 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. Caution is also warranted for patients who have undergone recent surgeries or have diseases with a high risk of bleeding and those using other anticoagulants. Patients with reduced kidney function or diseases with a high risk of bleeding may have an increased risk of bleeding when using this medication, so it should be used cautiously. Co-administration with drugs such as non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors may further elevate the risk of bleeding, so caution should be exercised. Blood tests should be performed regularly to monitor for symptoms of bleeding or anemia while taking this medication. If severe bleeding occurs, treat the bleeding site and seek emergency care if necessary. For other medications that may interact with this medicine, particularly certain antifungals, antivirals, some antibiotics, and other anticoagulants, consultation with a healthcare professional or pharmacist is required due to an increased risk of bleeding. It is safest for pregnant or breastfeeding women to avoid this medication, and women of childbearing age must take precautions to avoid pregnancy while on this treatment. In older patients, drug levels may increase due to decreased kidney function, but generally no special dosage adjustments are necessary; however, caution is needed as the risk of bleeding may be elevated. Its safety and effectiveness have not been established for children and adolescents under 18 years of age, so it is not recommended for this population. The risk of bleeding may increase with overdose, so careful monitoring is necessary, and appropriate treatment should be received if needed. Drowsiness or fainting may occur when operating a vehicle or machinery, therefore caution should be exercised if these symptoms are experienced. If surgery or invasive procedures are planned, this medication should be discontinued for a certain period before the procedure, and measures to reduce the risk of bleeding are necessary. Abrupt discontinuation of this medication may increase the risk of thrombosis, so when discontinuing, consultation with a doctor is essential to receive appropriate alternative therapy. Patients requiring anticoagulation therapy must inform their doctor immediately of any symptoms of bleeding or adverse reactions while on this medication and must adhere to the treatment plan.

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

This medication may be sensitive to air or humidity, hence it should be stored in a tightly sealed container. It is essential to maintain the storage temperature between 1 and 30 degrees Celsius to ensure the medication's effectiveness for a prolonged period.

Appearance

Brownish red round film-coated tablet

Package unit

30 tablets/PTP [10 tablets/PTP × 3], 100 tablets/PTP [10 tablets/PTP × 10]