Rivaroxaban 15 mg Tablets

Adult dose

This drug 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered with food. 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose of this drug 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 drug 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. 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 drug 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 after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. 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 drug 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 drug is 10 mg once daily. The initial 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 drug If you forget to take this drug, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this drug 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. The daily dose must not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this drug ① Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist treatment and start taking this drug 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 vitamin K antagonist treatment and start taking this drug when the INR is ≤ 2.5. Regardless of the dose, INR values will be falsely elevated after taking this drug. INR should not be used because it is not suitable for measuring the anticoagulant activity of this drug. 2) Switching from this drug to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this drug to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this drug may affect INR elevation. Patients switching from this drug to a vitamin K antagonist should receive both this drug and the vitamin K antagonist 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 drug and a vitamin K antagonist concomitantly, INR should not be tested until 24 hours after taking this drug. Once this drug is discontinued, INR can be tested 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this drug In patients receiving a parenteral anticoagulant, start this drug 0~2 hours before the time of the next scheduled parenteral dose (e.g., low molecular weight heparin), or when a continuously administered parenteral anticoagulant (e.g., intravenous unfractionated heparin) is discontinued. 4) Switching from this drug to a parenteral anticoagulant Discontinue this drug and start the parenteral anticoagulant at the time the next dose of this drug 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. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the blood concentration of this drug increased significantly; therefore, this drug should be administered with caution. Administration of this drug is not recommended in patients with severe renal impairment with creatinine clearance less than 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). 5. For patients who cannot swallow tablets, Immediately before use, this drug may be crushed, mixed with water or a beverage such as applesauce, and administered orally. This drug may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this drug 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. Bleeding may occur during treatment, so signs of bleeding should be carefully monitored. If severe bleeding occurs, discontinue the medication immediately and consult a doctor. This medication should not be used in patients with certain liver conditions, pregnant or breastfeeding women, and patients with lactose intolerance. Recent bleeding or bleeding risk is also a contraindication for this medication. Caution is necessary if taken with other anticoagulants or certain antifungals, as the risk of bleeding may increase. Patients with impaired kidney function or conditions with a high risk of bleeding should use this medication cautiously. Regular checks for bleeding symptoms and signs of anemia should be performed, and healthcare personnel should be informed immediately if bleeding is suspected. This medication should be discontinued for a period prior to surgery or invasive procedures and resumed according to a doctor's instructions thereafter. Elderly patients may experience increased blood levels of this medication, but while no specific dosage adjustment is necessary, the risk of bleeding may be heightened. Women of childbearing potential should ensure contraception during use, and this medication should not be used during pregnancy. Overdosage increases the risk of bleeding, so dosages should be strictly adhered to, and any adverse reactions should be reported to medical professionals immediately. Caution is advised when driving or operating machinery, as drowsiness or fainting may occur.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. A storage temperature between 1 and 30 degrees Celsius is recommended to maintain its efficacy and safety for a prolonged period.

Appearance

Red round film-coated tablets

Package unit

7 tablets/box [(7 tablets/PTP)], 30 tablets/box [(10 tablets/PTP X 3)], 100 tablets/box [(10 tablets/PTP X 10)]