Jarelson Tablet 15 mg (Rivaroxaban)

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. Adults 1) 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. (See '12. Clinical Trial Information') 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 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 and dose of treatment 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. Duration of administration Frequency of administration Daily dose 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 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 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 based on 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 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, or 20 mg once daily: Take the missed dose immediately. Starting the next day, continue taking one tablet once daily. The daily dose should 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 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. ② 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. Regardless of the dose, the INR value will be falsely elevated after taking this medicine. The INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used for this purpose. 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 the increase in INR. Patients switching from this medicine to a vitamin K antagonist should take 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 contrast, patients receiving this medicine and a vitamin K antagonist concomitantly should not undergo INR testing until 24 hours have passed 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 product (e.g., low molecular weight heparin), or at the time of discontinuation of a continuously administered parenteral product (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 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 medicine increased significantly; therefore, administer this medicine with caution. There is no clinical experience in patients with severe renal impairment with creatinine clearance less than 15 mL/min, and use of this medicine is not recommended. 1) 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. 2) 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 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 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. Patients who cannot swallow tablets, Immediately before use, this medicine may be crushed and mixed with a liquid such as water or applesauce for oral administration. It 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 blood coagulation. During use, bleeding may occur, so it is important to carefully monitor any signs or symptoms of bleeding. If severe bleeding occurs, discontinue use immediately and consult a doctor. There are patients who should not take this medication. For example, those who are allergic to this drug or its components, have severe bleeding, have very poor liver function, are pregnant or breastfeeding, or have certain genetic lactose intolerance conditions. Additionally, patients with a recent history of gastrointestinal ulcers or intracranial hemorrhage, or those with diseases with increased bleeding risk should not take this medication. If taken in combination with other anticoagulants or certain antifungal agents, the risk of bleeding may increase significantly, so caution is needed. Patients with decreased kidney function or with diseases that increase bleeding risk should use this medication cautiously and determine whether to take it based on the doctor's judgment. Extra caution is required when taken together with drugs that increase the risk of bleeding, such as non-steroidal anti-inflammatory drugs (NSAIDs) or platelet aggregation inhibitors. During the use of this medication, persistent monitoring for bleeding symptoms or signs of anemia (fatigue, pallor, dizziness, etc.) is necessary, and any abnormal symptoms should be reported to medical personnel immediately. In cases of severe bleeding, appropriate treatment such as physical pressure, surgical hemostasis, or blood component administration may be needed. Additionally, this medication should not be used during pregnancy, and women who may become pregnant should practice contraception while taking it. Breastfeeding women should also avoid taking this medication. Elderly patients might have increased blood concentration due to decreased kidney function, hence the risk of bleeding may be heightened, but no special dosage adjustment is needed. This medication is not recommended for children or adolescents under 18 years of age as its safety and efficacy have not been established. The risk of bleeding increases with overdose, so strict adherence to the dosage is essential; if an overdose is suspected, medical personnel should be notified immediately and any bleeding symptoms should be closely monitored. Drowsiness or fainting may occur while taking this medication, so caution is needed when driving or operating machinery. Lastly, patients receiving this medication have an increased risk of bleeding during spinal anesthesia or lumbar puncture, so special attention is required before and after these procedures.

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

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is also recommended to store the medicine at room temperature between 1°C and 30°C.

Appearance

Red round film-coated tablets

Package unit

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