Xarelto 15 mg (Rivaroxaban)

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 stenting. (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 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 after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative to 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 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 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. 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. Do not take twice the recommended daily dose 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) 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 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, as 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 both medicines 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 a dose of the vitamin K antagonist according to INR testing. 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 time of the next scheduled parenteral dose (e.g., low molecular weight heparin), or at the time of discontinuation of a continuously administered parenteral drug (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 (creatinine clearance 50-80 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that plasma concentrations of this medicine were significantly increased; therefore, administer this medicine with caution. Administration of this medicine is not recommended in patients with severe renal impairment (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 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 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 increased risk of bleeding may occur in these patients. 5. Patients unable to swallow tablets, Immediately before use, this medicine may be crushed and mixed with water or a liquid 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 an anticoagulant that prevents blood from clotting. Therefore, the risk of bleeding may increase, and signs of bleeding should be carefully monitored. If serious bleeding occurs, discontinue the use of this medication immediately. This medication should not be administered to patients with certain diseases or conditions. For example, it should not be used in patients with allergies to its components, currently experiencing serious bleeding, severe liver dysfunction, or those who are pregnant or breastfeeding, as well as patients with genetic issues such as lactose intolerance. Patients with a high risk of bleeding such as those with a history of gastrointestinal ulcers, history of intracranial hemorrhage, vascular abnormalities, or recently undergone brain or spinal surgery should avoid its administration. Patients with renal impairment or other conditions that increase the risk of bleeding should use this medication with caution. Care should also be taken when taking medications that increase the risk of bleeding, such as non-steroidal anti-inflammatory drugs (NSAIDs) or platelet aggregation inhibitors. During the treatment with this medication, patients should continuously monitor for symptoms of bleeding or anemia, and if sudden dizziness, pallor, shortness of breath, or unexplained swelling occurs, they should consult a healthcare professional immediately. Additionally, this medication can interact with certain antifungal agents, antibiotics, and anticoagulants, which may increase the risk of bleeding, so patients must inform their doctor or pharmacist of any medications they are taking. Women who are pregnant or planning to become pregnant should ensure contraception while taking this medication, and breastfeeding women should avoid using this medication. Elderly patients may experience an increase in blood concentration due to renal function decline, but no separate dose adjustment is necessary, although the risk of bleeding may be increased. Overdose may increase the risk of bleeding, so doses must be strictly adhered to, and if bleeding symptoms appear, patients should visit a hospital immediately for appropriate treatment. This medication may cause drowsiness or dizziness during driving or operating machinery, so if these symptoms occur, patients should avoid driving or hazardous activities.

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

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture and should be kept at room temperature between 1°C and 30°C. Proper storage will help maintain the efficacy of the medication for a longer period.

Appearance

Red round film-coated tablet

Package unit

28 tablets/box [(14 tablets/PTP packaging x 2)], 30 tablets/box [(10 tablets/PTP packaging x 3)], 100 tablets/box [(10 tablets/PTP packaging x 10)]