Rivaroxaban Tablet 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 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 underwent percutaneous coronary intervention (PCI) with stent placement. 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 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 in the risk of recurrence — Days 1-21: 15mg twice daily, total daily dose 30mg Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence — From day 22: 20mg once daily, total daily dose 20mg Reduction in 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. 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 administered 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. If you miss a dose of this medicine: Patients taking 15 mg twice daily should 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. Patients taking 10, 15, or 20 mg once daily should take the missed dose immediately. Starting the next day, continue taking 1 tablet once daily. The daily dose should not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this medicine — 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. Switching from a vitamin K antagonist to this medicine — 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 INR is ≤ 2.5. Regardless of the dose, INR values will be falsely elevated after taking this medicine. INR is not appropriate for measuring the anticoagulant activity of this medicine and should not be used. 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 both medicines until INR is ≥2.0. During 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 testing. Patients receiving this medicine and a vitamin K antagonist concomitantly should not have INR testing until 24 hours after taking this medicine. Once this medicine has been 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 with 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 are significantly increased; therefore, administer this medicine with caution. As there is no clinical experience in patients with severe renal impairment with creatinine clearance below 15 mL/min, use of this medicine is not recommended. Patients with renal impairment — 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. Patients with renal impairment — 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).

This medication is used to prevent or treat blood clots by inhibiting blood coagulation. During treatment, bleeding may occur, so signs of bleeding must be monitored closely. If severe bleeding occurs, immediately stop taking the medication and consult a doctor. This medication should not be given to patients with certain liver diseases, pregnant or breastfeeding women, and patients with specific genetic lactose intolerance. Special caution is needed for patients at high risk of bleeding or those taking other anticoagulants. Patients with impaired renal function should also be cautious, and the use should be determined by a doctor due to increased bleeding risk. When taken with drugs that increase bleeding risk, such as non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors, the bleeding risk may increase. During the administration of this medication, symptoms such as anemia, bleeding, dizziness, headache, skin rash may appear, so caution is advised. Particularly during pregnancy, the use should be avoided due to potential risks to the fetus, and consultation with healthcare professionals is necessary if breastfeeding. Elderly patients may experience higher blood levels when taking this medication, although dosage adjustments are generally not required; however, the risk of bleeding may increase. The safety and efficacy in children and adolescents have not been established, thus it is not recommended. In cases of overdose, the risk of bleeding increases, so if overdose is suspected, seek medical attention immediately. This medication may interact with certain antifungals, antivirals, antibiotics, etc., so inform healthcare professionals of any other medications being taken. It may be necessary to stop taking this medication before surgery or invasive procedures, so discuss it with your doctor in advance. Drowsiness or dizziness may occur while driving or operating machinery, so be cautious when symptoms are present. If severe skin reactions or allergic symptoms occur while taking this medication, immediately stop taking it and consult your healthcare provider. This medication may affect blood coagulation tests; be sure to inform the healthcare provider of its use during testing.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. Avoid direct sunlight and keep it in a cool place.

Appearance

Brownish red round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP*3)], 100 tablets/box [(10 tablets/PTP*10)]