Ankuk Rivaroxaban Tablet 20 mg

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered with food. 1) Reduction in the risk of stroke and systemic embolism in patients with non-valvular 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 non-valvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement. 2) 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 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 compared with 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 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 during 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 given 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 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. 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 medicines Stop treatment with a vitamin K antagonist and start taking this medicine when the International Normalized Ratio (INR) is ≤ 3.0. Stop treatment with a vitamin K antagonist and start taking this medicine when the INR is ≤ 2.5. 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 based on INR testing. In patients receiving this medicine concomitantly with a vitamin K antagonist, INR testing must not be performed until 24 hours after taking this medicine. Once this medicine has been discontinued, INR testing may be performed 24 hours after the last dose. In patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the next scheduled dose of the parenteral medicine (e.g., low molecular weight heparin), or at the time of discontinuation of a continuously administered parenteral medicine (e.g., intravenous unfractionated heparin). 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 the blood concentration of this medicine increased significantly; therefore, administer this medicine with caution. Administration of this medicine is not recommended in patients with severe renal impairment and creatinine clearance below 15 mL/min because there is no clinical experience in this population. Reduction in the risk of stroke and systemic embolism in patients with non-valvular 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. 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): 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. 5. Patients unable to 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 an anticoagulant used to prevent or treat blood clot formation. During treatment, signs of bleeding should be carefully monitored, and if severe bleeding occurs, the use of this medication must be discontinued immediately. This medication should not be used in certain patients, such as those with allergies to the active ingredient or components, those with existing serious bleeding, patients with severely impaired liver function, pregnant or breastfeeding women, patients with lactose intolerance, patients with diseases that pose a high risk of recent bleeding, and those taking other anticoagulants or specific antifungal medications. Patients with impaired kidney function or conditions that pose a high risk of bleeding should use this medication cautiously, and care is also needed when used in conjunction with medications that increase the risk of bleeding such as non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors. When taking this medication, various side effects such as bleeding, anemia, skin rashes, gastrointestinal symptoms may occur; if abnormal symptoms appear, one should consult a healthcare provider immediately. Especially in elderly patients or those with impaired kidney function, blood concentration may increase, elevating the risk of bleeding, so additional caution is necessary. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential must use contraception while taking it. In cases of overdose, the risk of bleeding may increase, so the healthcare provider should be informed immediately, and appropriate treatment should be received if necessary. This medication may affect driving or operating machinery, so if symptoms such as drowsiness or dizziness occur during use, caution is advised. Finally, this medication may have interactions with other medications, so if other medications are being taken, healthcare providers must be informed. It is important not to stop this medication abruptly, as this may increase the risk of thrombosis; hence, if discontinuing, appropriate alternative treatment should be provided under a doctor’s guidance.

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

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is best stored at room temperature between 1°C to 30°C. This will help maintain the effectiveness of the medication for a long time.

Appearance

Round film-coated tablets that are red with a brown tint

Package unit

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