Javoban 20 mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered with food. 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 with concomitant administration for up to 12 months of rivaroxaban 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] and a P2Y12 inhibitor in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement. 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, is 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 individualized assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism in relation to 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 administration for 6 months or longer: 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. Prevention of venous thromboembolism in adult patients who have undergone 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 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. Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg 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. 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 therapy and start taking this medicine when the International Normalized Ratio (INR) is ≤ 3.0. Switching from a vitamin K antagonist to this medicine—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 therapy 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. 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 when switching to another anticoagulant. Note that this medicine may affect INR elevation. Patients switching from this medicine to a vitamin K antagonist should receive both this medicine and the vitamin K antagonist 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 vitamin K antagonist dose according to 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. 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 when a continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 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. 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 plasma concentration 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 with creatinine clearance less than 15 mL/min, as there is no clinical experience in these patients. Patients with renal impairment—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. Patients with renal impairment—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 who have undergone 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). 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. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 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 drug prevents or treats the formation of blood clots by inhibiting blood coagulation. Therefore, during the use of this medication, one must be very cautious of bleeding symptoms. In particular, if severe bleeding occurs, you must stop taking the medication immediately and follow the doctor's instructions. This medicine should not be administered to certain patients, such as those allergic to this drug or its components, those with existing severe bleeding, those with certain liver diseases, or those who are pregnant or breastfeeding. It should also be avoided in patients with several conditions with high bleeding risks or who are taking other anticoagulants. Caution should be exercised when administering to patients with renal impairment, as the use of other drugs may increase the risk of bleeding, so it is essential to consult a doctor. This drug can cause various adverse reactions, including bleeding, anemia, skin rash, and liver function abnormalities, so patients should inform their healthcare provider immediately if symptoms occur. In particular, elderly patients or those with reduced renal function may be at higher risk of bleeding and should be monitored closely. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age must consult their doctor regarding pregnancy planning. This drug may interact with specific medications, affecting blood concentrations; therefore, anyone taking other medications must inform their doctor or pharmacist. If undergoing surgical or invasive procedures, consult healthcare providers about when to appropriately stop or resume the medication. Caution is required as drowsiness or dizziness may occur when driving or operating machinery. Overdose significantly increases the risk of bleeding, so it is crucial to adhere to the prescribed dosage. If any bleeding symptoms, anemia, skin rash, severe headache, or dizziness occur while taking this medication, medical attention must be sought immediately.

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

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

Brownish-red round film-coated tablets

Package unit

30 tablets (10 tablets/PTP packaging x 3), 100 tablets (10 tablets/PTP packaging x 10)