Aza-rel Tablet 20 mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered with or without food, whereas 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 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 dose should be determined after an individualized assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Duration of administration / Frequency of administration / 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 administration for 6 months or longer / 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 during 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 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; 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, 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, 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 when 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; thereafter, administer a 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 have elapsed after taking this medicine. Once this medicine has been 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 when continuous administration of a parenteral agent (e.g., intravenous unfractionated heparin) is stopped. 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 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 was significantly increased; therefore, administer this medicine with caution. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min because there is no clinical experience in this patient 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 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 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 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 blood clot formation by inhibiting blood coagulation. During treatment, there may be a risk of bleeding, so careful monitoring for signs or symptoms of bleeding is necessary. If a serious bleeding occurs, discontinue the medication immediately and follow a doctor's instructions. This medication should not be given to patients with certain diseases or conditions. For example, those allergic to any ingredient in this medication, patients with serious bleeding, those with severely impaired liver function, pregnant or breastfeeding women, and patients with lactose intolerance should avoid this medication. Additionally, patients with a recent history of gastrointestinal ulcers or intracranial hemorrhage, vascular abnormalities, or those with a high risk of bleeding cancers should not use this medication. Patients with impaired renal function or those with diseases that increase the risk of bleeding must exercise caution when using this medication, especially when taken with other drugs that also raise bleeding risks. This medication can cause various side effects, with bleeding being the most common, which may include gum bleeding, gastrointestinal bleeding, hematuria, and bruising. Dizziness, headaches, anemia, liver function abnormalities, and allergic reactions have also been reported. In severe cases, life-threatening bleeding or skin reactions may occur, so any unusual symptoms should be reported to healthcare professionals immediately. This medication may pose risks to the fetus during pregnancy, so it is essential for women who are pregnant or planning to become pregnant to consult their doctor. Breastfeeding women should also avoid taking this medication. Elderly patients may have an increased blood concentration of this medication due to decreased renal function; therefore, while no specific dosage adjustment is needed, caution is advised due to the increased risk of bleeding. Safety in children and adolescents has not been established, and its use is not recommended. In cases of overdose, the risk of bleeding may be significantly increased; therefore, patients should seek medical attention immediately. This medication may interact with various other drugs, so if taking other medications, inform your doctor or pharmacist right away. In particular, the risk of bleeding may increase when used with strong antifungal agents, certain antibiotics, anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs), and antiplatelet agents. If planning for surgery or invasive procedures, this medication may need to be discontinued; consult your healthcare professional. Dizziness or drowsiness may occur while driving or operating machinery, so caution is advised. Always remain vigilant for any signs of bleeding or unusual symptoms during treatment and take this medication strictly as directed by your physician.

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

This medication should be stored in a tightly closed container as it may be sensitive to air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature to ensure the effectiveness and safety of the medication.

Appearance

Brownish-red round film-coated tablet

Package unit

7 tablets/box [7 tablets/PTP packaging], 30 tablets/box [10 tablets/PTP packaging * 3], 100 tablets/box [10 tablets/PTP packaging * 10]