Xarelto 10 mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered with or without food, 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 15 mg once daily [10 mg 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 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 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 compared with 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 established. 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 Discontinue vitamin K antagonist treatment and start taking this medicine when the International Normalized Ratio (INR) is ≤ 3.0. ②Treatment 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 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 an increase in the INR. Patients switching from this medicine to a vitamin K antagonist should receive both medicines concomitantly until the INR is ≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer the vitamin K antagonist dose based on INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this medicine. Once this medicine is discontinued, INR testing may be performed 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine For 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 (creatinine clearance 50-80 mL/min). Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the blood concentration of this medicine increased significantly; therefore, administer this medicine with caution. Use of this medicine is not recommended in patients with severe renal impairment and 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 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 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 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 the formation of clots by inhibiting excessive clotting. During the course of this medication, there is a risk of bleeding, so careful observation for signs of bleeding is necessary. If severe bleeding occurs, this medication should be discontinued immediately and medical personnel should be informed. This drug should not be used in patients with certain diseases or conditions, such as those with severe bleeding, significant liver impairment, or women who are pregnant or breastfeeding. Additionally, this medication contains lactose, so patients with lactose intolerance should avoid it. Special caution is required for patients with conditions or diseases that increase the risk of bleeding or those taking other anticoagulants. Patients with impaired renal function should be given this medication with care, as higher blood concentrations may increase the risk of bleeding. Care should also be taken when used in combination with non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors that may increase bleeding risk. While taking this medication, patients should closely monitor for bleeding symptoms and signs of anemia, and consult medical professionals immediately if any unusual symptoms appear. This medication may interact with certain drugs, so it is essential to inform healthcare providers of any medications currently being taken. Women who are pregnant or planning to become pregnant should ensure contraception during the use of this drug, and breastfeeding women are advised to avoid it. Elderly patients may have higher concentrations of this medication due to decreased renal function, but no special dose adjustment is necessary. This medication is not recommended for children and adolescents under 18 years of age as safety and efficacy have not been established. Overdose may increase the risk of bleeding, so care must be taken not to exceed the recommended dosage; if an overdose is suspected, seek medical advice immediately. Caution is advised when driving or operating machinery while taking this medication, as drowsiness or dizziness may occur. If undergoing surgery or invasive procedures, consult healthcare providers about discontinuing this medication before the procedure. The risk of bleeding may increase if this drug is used in conjunction with regional anesthesia (epidural or spinal anesthesia), so special caution is required in such cases. Patients with a history of cardiovascular disease or thrombosis should evaluate the risks of bleeding and thrombosis balance closely while taking this medication and consult healthcare providers closely. If severe rash or allergic reactions occur, discontinue this medication immediately and consult healthcare professionals.

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

This medication should be stored in a tightly closed container to avoid exposure to air and moisture, and it is best kept at room temperature between 1 degree and 30 degrees. Storing it this way will help maintain the medication's efficacy for a longer period.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP packaging X 3]