Rivaflo 15 mg (Rivaroxaban)

Adult dosage

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 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 in 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 to reduce 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 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 in the risk of recurrence Days 1-21 15mg twice daily 30mg From day 22 20mg once daily 20mg Reduction in 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 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 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 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 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 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 treatment with the vitamin K antagonist 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 in the risk of recurrence of deep vein thrombosis and pulmonary embolism Discontinue treatment with the vitamin K antagonist 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 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 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 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 required in patients with mild renal impairment with a creatinine clearance of 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. Administration of this medicine is not recommended in patients with severe renal impairment with a creatinine clearance below 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 in 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 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. 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 gastric tube. Before administering this medicine through a gastric 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 signs of bleeding must be observed closely. If severe bleeding occurs, this medication should be discontinued immediately, and appropriate treatment should be received as directed by a physician. This medication should not be administered to certain patients, such as those with allergies to this medication or its components, patients with active severe bleeding, patients with severe liver dysfunction, pregnant or breastfeeding women, and patients with certain hereditary conditions such as lactose intolerance. Medication should also be avoided in patients with a recent history of gastrointestinal ulcers, intracranial hemorrhage, certain vascular anomalies, or malignant tumors. Due to the increased risk of bleeding when used with other anticoagulants, caution is required, and in some cases, concomitant use is prohibited. Patients with decreased renal function or high risk of bleeding diseases should use this medication carefully, and caution is needed when co-administered with other drugs that may increase bleeding risk. This medication may cause various side effects including bleeding, anemia, gastrointestinal disturbances, allergic reactions, etc., and if any unusual symptoms arise, immediate consultation with medical personnel is required. Particularly, if severe bleeding, skin rashes, or mucosal ulcers occur, use should be stopped immediately and medical attention should be sought. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential must use contraception while taking this medication. Elderly patients may have increased blood concentrations of this medication due to decreased renal function; however, dosage adjustments are generally not required, though bleeding risk may increase. This medication is not recommended for children or adolescents, as safety and efficacy have not been established. In cases of overdose, the risk of bleeding may increase, and since there are no specific antidotes, immediate medical attention is required. Caution is advised when driving or operating machinery while taking this medication, as drowsiness or dizziness may occur. Concomitant use with certain antifungals, antivirals, antibiotics, etc., can alter the blood concentration of this medication, thus modifying bleeding risk, and consultation with a physician is advised. Prior to surgical or invasive procedures, this medication should be discontinued for a certain period, and appropriate measures should be taken to reduce the risk of bleeding. Abruptly stopping this medication may increase the risk of thrombosis, so dosage should be adjusted according to physician's instructions.

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

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Red, round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP packaging x3)], 100 tablets/box [(10 tablets/PTP packaging x10)]