Jarelson 20 mg (Rivaroxaban) Tablet

Adult dose

This medicine 10 mg may be taken with or without food, while 15 mg and 20 mg should be taken with food. 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 in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement using rivaroxaban 15mg once daily [10mg once daily for patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] in combination with a P2Y12 inhibitor for up to 12 months. 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 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 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 medicine is 30 mg during the first 3 weeks of treatment and 20 mg during the subsequent 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 ① Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at once. Starting the next day, continue taking 15 mg twice daily. ② Patients taking 10, 15, 20 mg 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 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. 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, 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 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 the dose based on INR testing. Patients receiving this medicine and a vitamin K antagonist concomitantly should not undergo INR testing until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR testing may be performed 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine For 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 discontinuing a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 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 and creatinine clearance of 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, administer this medicine with caution. There is no clinical experience in patients with severe renal impairment and creatinine clearance below 15 mL/min; therefore, use of this medicine is not recommended. 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. 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 administering this medicine to patients with liver disease associated with coagulopathy and to patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. 5. Patients who cannot swallow tablets Immediately before use, this medicine may be crushed and mixed with water or a beverage such as 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 drug is used to prevent or treat blood clots by inhibiting blood coagulation. During treatment, careful observation for signs of bleeding is required, especially in patients at increased risk of bleeding. If severe bleeding occurs, this medication should be stopped immediately and medical advice should be followed. This drug may affect certain blood coagulation test results, but regular blood monitoring is generally not necessary. This medication should not be used in patients with allergies to the active ingredient or excipients, those with clinically significant bleeding, severely impaired liver function, or women who are pregnant or breastfeeding. Additionally, patients with lactose intolerance or certain genetic metabolic disorders should not take this medication. Patients with recent gastrointestinal ulcers, history of intracranial hemorrhage, spinal or brain surgeries, or patients with malignancies at high risk of bleeding should also avoid this medication. Patients with impaired kidney function or bleeding disorders should use this medication cautiously, as the risk of bleeding can increase when combined with other anticoagulants or drugs affecting hemostasis. Care must be taken if used with non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors, and this medication should only be administered if its benefits outweigh the risks. Anemia or bleeding symptoms may occur during the use of this medication; therefore, patients should consult a physician immediately if experiencing dizziness, pallor, abnormal bleeding or bruising, or difficulty breathing. If bleeding is uncontrolled, additional treatment may be necessary based on the doctor's judgment. This medication may interact with certain antifungals, antivirals, and antibiotics, increasing the risk of bleeding when used in combination, so patients should inform healthcare providers of any other medications being taken. During pregnancy, this medication may harm the fetus, so contraceptive measures are necessary during treatment, and breastfeeding should be discontinued before taking this medication. Older adults may have increased blood levels of this medication due to impaired kidney function, but no specific dosage adjustment is needed; however, caution is advised as the risk of bleeding may increase. Safety and efficacy in children and adolescents under 18 years of age have not been established and is not recommended. In the event of overdose, the risk of bleeding may increase, and immediate medical attention should be sought. This drug is not removed by renal dialysis, so caution is needed. Drowsiness or fainting may occur when driving or operating machinery, so these activities should be avoided if such symptoms occur. During treatment, regular checks for signs of bleeding should be performed, and appropriate measures should be taken in consultation with healthcare providers in situations of high bleeding risk.

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

This medication may be sensitive to air or moisture and should be stored in a tightly closed container. The storage temperature should be maintained between 1°C and 30°C at room temperature. By storing it this way, the medication's effectiveness can be safely preserved.

Appearance

Brownish-red, round, film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3], 100 tablets/box [10 tablets/PTP x 10]