Javoban 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 for 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 versus the risk of bleeding. Treatment period Dosing frequency 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 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; a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. 4) If you miss a dose of this medicine If you miss a dose of 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. From the following day, continue taking 15 mg twice daily. ② 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 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 therapy 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 therapy 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 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 must 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. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose based on INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, INR testing should not be performed until 24 hours 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 In patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the time of the next scheduled parenteral dose (e.g., low molecular weight heparin), or at the time of discontinuation of 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 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 plasma concentrations of this medicine increased significantly; therefore, administer this medicine with caution. Use 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 these patients. 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 necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 4. Patients with hepatic impairment Avoid use 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. Patients who cannot swallow tablets, Immediately before use, this medicine may be crushed, mixed with a drink 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 prevents blood clotting and thrombus formation. During treatment, the risk of bleeding may increase, so symptoms of bleeding must be carefully monitored. If severe bleeding occurs, the medication should be stopped immediately, and the doctor's guidance should be followed. This medication should not be given to patients with certain diseases or conditions, particularly those with severe bleeding, severely impaired liver function, pregnant or breastfeeding women, and patients with specific genetic lactose intolerance. Caution is also needed for patients with reduced kidney function or high bleeding risk when using this medication, especially if taking other anticoagulants or medications that increase bleeding risk. This medication can cause various adverse effects, and monitoring for symptoms related to bleeding is important. Contact medical personnel immediately if bleeding is suspected and receive appropriate treatment. Caution should also be taken when driving or operating machinery, as symptoms such as drowsiness or fainting may occur. Additionally, this medication may interact with various drugs, so patients should inform their doctor or pharmacist about any other medications they are taking. Women who are pregnant or planning to become pregnant should not take this medication, and effective contraception is necessary during treatment. Breastfeeding women should also avoid taking this medication and should wait until after stopping breastfeeding to use it. The elderly may be at increased risk of bleeding, although dose adjustments are generally not needed. Overdose can significantly increase the risk of bleeding, so the prescribed dosage and regimen must be strictly adhered to. It may be necessary to discontinue this medication before surgery or procedures, so consult with medical personnel beforehand.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage can help preserve the medication's efficacy for a longer duration.

Appearance

Red circular film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging X3), 100 tablets (10 tablets/PTP packaging X10)