Rivaroxaban Tablet 20mg (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 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 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. 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 following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative 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, total daily dose 30mg From day 22: 20mg once daily, total daily dose 20mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism After at least 6 months of treatment: 10mg once daily, total daily dose 10mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter during 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 initial 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 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 forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ①Patients 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. ②Patients taking 10, 15, or 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 ①Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Stop treatment with the vitamin K antagonist and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. ②Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Stop treatment with the vitamin K antagonist 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 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 receive 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; thereafter, administer the dose of the vitamin K antagonist according to INR test results. 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 next scheduled dose of the parenteral product (e.g., low-molecular-weight heparin), or when the continuously administered parenteral product (e.g., intravenous unfractionated heparin) is discontinued. 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 blood concentrations 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 (creatinine clearance less than 15 mL/min), as there is no clinical experience in these patients. 1) 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. 2) 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 necessary 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. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 5. Patients unable to swallow tablets Immediately before use, this medicine may be crushed and 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 serves as an anticoagulant to prevent excessive blood clotting and carries a risk of bleeding; thus, signs of bleeding should be carefully monitored. In cases of severe bleeding, the use of this drug should be immediately discontinued, and routine blood concentration monitoring during treatment is generally not required. It should not be administered to patients with known allergies to this drug, clinically relevant bleeding, severe liver disease, pregnant or breastfeeding women, or patients with specific genetic lactose intolerance. It is also advisable to avoid this medication in patients with a recent history of gastrointestinal ulcers, intracranial bleeding, or surgical history involving the brain or spinal cord, as they are at high risk of bleeding. Using this drug in combination with other anticoagulants increases the risk of bleeding, so concomitant use should be avoided, and caution is required when used alongside certain antifungal or antibiotic medications. Patients with impaired renal function, bleeding disorders, uncontrolled hypertension, or active gastrointestinal diseases should use this drug with caution. The risk of bleeding may increase when used with non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors. This medication could cause anemia or various bleeding complications. Symptoms of bleeding may include dizziness, pallor, and dyspnea. If bleeding is suspected, appropriate treatment should accompany adjustment of the medication, and in severe bleeding cases, professional emergency treatment may be necessary. This drug should be discontinued for a certain period before surgical or invasive procedures, and care is required during regional anesthesia or lumbar puncture due to an increased bleeding risk. This drug should not be used during pregnancy as it may harm the fetus, and it is also safer to avoid administration while breastfeeding. Elderly patients may have elevated blood concentration due to diminished renal function; however, special dosage adjustments are not generally required, though bleeding risk may be increased. Safety in children and adolescents under 18 has not been established, hence use is not recommended. Caution should be exercised as overdose increases the risk of bleeding, and this drug is not removed by dialysis. Dizziness or drowsiness may occur while driving or operating machinery, so caution is necessary. This drug can interact with other medications, thus it is important to consult a physician or pharmacist if taking other medications.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help preserve the drug's effectiveness and prevent degradation.

Appearance

Brownish red, round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP x 3)]