Barreto Tablet 20 mg (Rivaroxaban)

Adult dose

This 10 mg medication may be administered with or without food; the 15 mg and 20 mg doses 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 medication 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 medication is 20 mg. There is limited experience with concomitant administration of rivaroxaban 15mg once daily [10mg once daily for 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 medication 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 treatment 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 versus the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21: 15mg twice daily, total daily dose 30mg From day 22: 20mg once daily, total daily dose 20mg Reduction of 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 medication is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. 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 medication is 10 mg once daily. The first dose should be given 6~10 hours after surgery, once hemostasis has been confirmed. The duration of treatment depends on each patient's risk of venous thromboembolism based on the type of surgery; however, treatment for 5 weeks is recommended for patients undergoing hip replacement and for 2 weeks for patients undergoing knee replacement. 4) If you miss a dose of this medication If you miss a dose of this medication, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this medication immediately; in this case, 2 tablets of 15 mg may be taken at once. 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 must not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medication 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 medication 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 treatment and start taking this medication when the INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this medication. INR is not suitable for measuring the anticoagulant activity of this medication and should not be used. 2) Switching from this medication to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this medication to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this medication may affect INR elevation. Patients switching from this medication to a vitamin K antagonist should receive both medications 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 medication together with a vitamin K antagonist, INR should not be tested until 24 hours after taking this medication. Once this medication is discontinued, INR may be tested 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medication For patients receiving a parenteral anticoagulant, start this medication 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low-molecular-weight heparin), or when a continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 4) Switching from this medication to a parenteral anticoagulant Discontinue this medication and start the parenteral anticoagulant at the time the next dose of this medication would have been due. 3. Patients with renal impairment No dose adjustment is required 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 the blood concentration of this medication increased significantly; therefore, administer this medication with caution. Administration is not recommended in patients with severe renal impairment and creatinine clearance below 15 mL/min because there is no clinical experience in this population. 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 required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 4. Patients with hepatic impairment Avoid administering this medication 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 medication and an increased risk of bleeding may occur in these patients. 5. Patients who cannot swallow tablets, Immediately before use, this medication may be crushed, mixed with water or a beverage such as applesauce, and administered orally. This medication may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this medication through a gastrointestinal tube, confirm that the tube is correctly positioned and flush the tube with water after administration.

This drug may increase the risk of bleeding, so signs of bleeding should be closely monitored during administration. If severe bleeding occurs, the medication should be stopped immediately, and conditions should be assessed through blood tests if necessary. This medication should not be given to patients with an increased risk of bleeding, those with certain liver diseases, pregnant or breastfeeding women, and patients with lactose intolerance. Caution should be exercised when used in patients with reduced kidney function or those with diseases that have a high risk of bleeding, and particularly when used in combination with other anticoagulants or certain antifungal agents. This drug can cause various adverse reactions related to bleeding, so if any symptoms of bleeding or anemia occur, immediate consultation with healthcare professionals is necessary. Additionally, caution is needed when used in conjunction with non-steroidal anti-inflammatory drugs or platelet inhibitors, which may increase the risk of bleeding. Pregnant or breastfeeding women should not take this drug, and women of childbearing potential must use contraception while on treatment. Elderly patients or those with reduced kidney function may have increased blood concentration, elevating the risk of bleeding; however, dosage adjustments are generally not necessary. In the event of an overdose, the risk of bleeding increases significantly, so immediate assessment and appropriate treatment by a healthcare professional are required. This drug may affect driving or operation of machinery, so attention should be paid if drowsiness or dizziness occurs during use. For those undergoing surgery or invasive procedures, discontinuation of the medication should occur some time prior, and measures should be taken to minimize the risk of bleeding. During the use of this drug, it is important to periodically check for signs of bleeding and consult healthcare professionals immediately if any abnormal symptoms arise.

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

This medication should be stored in a tightly closed container to protect it from air and light exposure, at room temperature between 1 degree and 30 degrees Celsius. Storing it this way can help maintain the effectiveness of the medication for a long time.

Appearance

Brownish red round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3), 100 tablets (10 tablets/PTP x 10)