Arixaban 15mg (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. Reduction in 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. Treatment of deep vein thrombosis and pulmonary embolism/reduction in 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 treatment of deep vein thrombosis and pulmonary embolism and the recommended dose for reduction in 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 and dose of treatment should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence, days 1-21: 15mg twice daily, 30mg. Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence, from day 22: 20mg once daily, 20mg. Reduction in 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. 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; however, a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. If you forget to take this medicine: Patients taking 15 mg twice daily: Take this medicine as soon as possible; in this case, two 15 mg tablets may be taken at one time. From the following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose as soon as possible. From the following day, continue taking 1 tablet once daily. The daily dose should not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this medicine: For reduction in 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, International Normalized Ratio) is ≤ 3.0. For treatment of deep vein thrombosis and pulmonary embolism/reduction in 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. Switching from this medicine to a vitamin K antagonist: 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 based on INR testing. In patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this medicine. If this medicine is discontinued, INR testing may be performed 24 hours after the last dose. Switching from a parenteral anticoagulant to this medicine: 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). 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. Patients with renal impairment: No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Use with caution in patients with severe renal impairment (creatinine clearance 15-29 mL/min). Use of this medicine is not recommended in patients with severe renal impairment and creatinine clearance less than 15 mL/min. For reduction in 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. No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min) for treatment of deep vein thrombosis and pulmonary embolism/reduction in 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). 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. For patients who cannot swallow tablets, this medicine may be crushed immediately before use 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 clotting by inhibiting clot formation. However, due to the risk of bleeding, any signs of bleeding should be reported to healthcare professionals immediately. This medication should not be used in certain patients, for instance, those allergic to this drug, those with severe bleeding, those with very poor liver function, pregnant or breastfeeding women, or patients with lactose intolerance should not take this medication. Patients with impaired kidney function or those with diseases that pose a high risk of bleeding should use this medication with caution, weighing the risk of bleeding against therapeutic effects. During treatment, patients should be closely monitored for signs of bleeding and symptoms of anemia, and if severe bleeding occurs, medication should be stopped and the patient should visit a hospital immediately. Additionally, combining with other anticoagulants or certain antifungal drugs, antibiotics, etc., may increase the risk of bleeding, so it is important to consult with a physician or pharmacist. Pregnant or breastfeeding individuals should avoid this medication, as it may be harmful to the fetus or newborn, and women of childbearing age should ensure contraception while taking this medication. Elderly patients may have increased blood concentration due to decreased kidney function; generally, dosage adjustments are not necessary, but the risk of bleeding may increase. Safety and efficacy have not been established for children and adolescents, so it is not recommended. In cases of overdose, the risk of bleeding may significantly increase, so strict adherence to dosing guidelines is critical; if overdose is suspected, hospital care should be sought immediately. This medication may affect the ability to drive or operate machinery; caution is advised if drowsiness or dizziness occurs. Regular blood tests and clinical evaluations during this treatment are important to monitor for bleeding, and for patients with high bleeding risk or those scheduled for surgery, discussions with a physician regarding timing of stopping the medication are needed.

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

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance

Red round film-coated tablets

Package unit

30 tablets/PTP [10 tablets/PTP packaging x3]