Yuhan Rivaroxaban 20 mg Tablet

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) 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 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 treatment 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 / Total 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 for the remainder of the treatment period. 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 each patient's risk of venous thromboembolism according to the type of surgery; treatment for 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 one time. 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) 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, the INR value 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 while switching to another anticoagulant. Note that this medicine may affect INR elevation. Patients switching from this medicine to a vitamin K antagonist should receive 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 a dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine concomitantly with a vitamin K antagonist, 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 when continuous administration of a parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 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 necessary 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 the plasma concentration of this medicine is significantly increased; therefore, administer this medicine with caution. Administration of this medicine is not recommended in patients with severe renal impairment and a creatinine clearance below 15 mL/min, as 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 necessary 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 a liquid 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 blood clots by inhibiting blood coagulation. During treatment, there may be a risk of bleeding, so signs of bleeding should be closely monitored. If severe bleeding occurs, the use of this medication should be stopped immediately. Patients who have an allergy to this medication, have severe bleeding conditions, have significantly impaired liver function, are pregnant or breastfeeding, or have certain genetic lactose intolerance should not take this medication. It is also advisable for patients who have a high risk of bleeding, such as those who have recently had gastrointestinal ulcers, cerebral hemorrhage, or brain or spinal surgery, to avoid this medication. Patients with impaired kidney function or those with bleeding risk conditions should use this medication cautiously, and care should be taken when taking other medications that affect blood coagulation as this may increase the risk of bleeding. Possible side effects of this medication include bleeding, anemia, gastrointestinal symptoms, skin rashes, and in severe cases, life-threatening bleeding or severe skin reactions. Therefore, if any unusual symptoms occur during treatment, the patient should inform their doctor immediately. Co-administration with specific antifungal agents or some antiviral medications may increase blood concentration and the risk of bleeding, so these medications should ideally not be used together. Conversely, some medications may reduce the efficacy of this drug, so consultation with a healthcare provider is advised when taking other medications. Women who are pregnant or planning to become pregnant must use contraception while taking this medication, and breastfeeding women may only take this medication after stopping breastfeeding. Elderly patients may have increased blood concentration due to decreased kidney function, but dosage adjustment is not necessary and the risk of bleeding may increase with age. This medication is not recommended for children and adolescents under 18 years due to insufficient safety and efficacy data. In case of overdose, the risk of bleeding significantly increases, and medical consultation should be sought immediately, as this medication binds strongly in the blood and cannot be removed by dialysis. Symptoms of drowsiness or fainting may occur, which could affect driving or operating machinery, so patients experiencing these symptoms should avoid driving or engaging in hazardous tasks. It is important to regularly monitor for bleeding and conduct blood tests while taking this medication, and patients scheduled for surgery or invasive procedures should consult with their physician for dose adjustment.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain storage temperature between 1°C and 30°C.

Appearance

Light red round film-coated tablet

Package unit

100 tablets/box [10 tablets/PTP X 10]