Zareba Tablet 18 mg (Rivaroxaban)

Adult dose

This medicine 10mg, 13.5mg, and 18mg may be administered with or without 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 18mg once daily. The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) is 13.5mg once daily. The maximum daily dose of this medicine is 18mg. There is limited experience with concomitant administration of rivaroxaban 13.5mg 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 medicine for the treatment of acute deep vein thrombosis and pulmonary embolism is 13.5mg 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 both 18mg once daily. After completing treatment for deep vein thrombosis or pulmonary embolism (at least 6 months), 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 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 13.5mg twice daily 27mg From day 22 18mg once daily 18mg 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 27mg during the first 3 weeks of treatment and 18mg 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 10mg once daily. The first dose should be administered within 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. 4) If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ① Patients taking 13.5mg twice daily: Take this medicine immediately; in this case, 2 tablets of 13.5mg may be taken at one time. Starting the next day, continue taking 13.5mg twice daily. ② Patients taking 10, 13.5mg, or 18mg once daily: Take the missed dose immediately. Starting the next 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 medicine 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 medicine when the international normalized ratio (INR, International Normalized Ratio) 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 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 should 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 based on INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, INR should not be tested until 24 hours after taking this medicine. Once this medicine is 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 at the time the continuously administered 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 (creatinine clearance 50-80 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine increased significantly; therefore, this medicine should be administered with caution. Administration of this medicine is not recommended in patients with severe renal impairment and creatinine clearance below 15 mL/min, as 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 13.5mg 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. For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with a liquid such as water or applesauce, and administered orally. 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 clots by inhibiting blood coagulation. During treatment, bleeding may occur, so signs of bleeding should be monitored closely. If severe bleeding occurs, the use of this medication must be stopped immediately. While this medication does not require dosage adjustments based on specific blood tests, measuring drug concentration in the blood may be helpful in emergencies. Patients with allergies to this medication, those experiencing serious bleeding, patients with significantly impaired liver function, pregnant or nursing women, and those with recent diseases that pose a high risk of bleeding should not take this medication. Additionally, caution is required when taking this medication with other anticoagulants or certain antifungal agents, as some combinations are not recommended. Patients with impaired kidney function or diseases that increase the risk of bleeding should use this medication cautiously, particularly when taken with other drugs that may increase bleeding risk. This medication may cause various side effects including bleeding, anemia, gastrointestinal disorders, and skin rash. If any unusual symptoms occur, immediate consultation with healthcare personnel is essential. In particular, symptoms of bleeding may present as pallor, dizziness, dyspnea, and severe pain, so vigilance is necessary. Elderly patients or those with reduced kidney function may need additional caution due to the potential for elevated blood concentration. Pregnant women should take precautions to avoid risk to the fetus, and nursing mothers are also advised against taking this medication. If surgery or invasive procedures are planned, this medication should be discontinued for a certain period as instructed by a physician. Caution is also needed when driving or operating machinery, as drowsiness or dizziness may occur during treatment. In case of overdose, the risk of bleeding increases, and immediate notification to healthcare personnel is necessary as dialysis is not effective for drug removal; specific treatments may be required.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture, at room temperatures between 1 degree and 30 degrees Celsius. This storage will maintain its effectiveness and prevent deterioration.

Appearance

Pale red circular film-coated tablet

Package unit

30 tablets/PTP [(10 tablets/PTP x 3)], 100 tablets/PTP [(10 tablets/PTP x 10)]