Eliquis 20 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 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 stenting. (See '12. Clinical Trial Information') 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 after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism in relation to the risk of bleeding. Treatment period / Frequency of administration / Total daily dose 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 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 initial dose should be started 6~10 hours after surgery, once hemostasis has been established. The duration of treatment depends on the individual 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. 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, 2 tablets of 15 mg may be taken at one time. 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 1 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 of 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 of 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, 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 take both medicines until the INR is ≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist, followed by a dose determined 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 can 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 agent (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 required in patients with mild renal impairment with a creatinine clearance of 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. Use of this medicine is not recommended in patients with severe renal impairment with a creatinine clearance below 15 mL/min because 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 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 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 who cannot swallow tablets Immediately before use, this medicine may be crushed and mixed with water or a beverage such as applesauce for oral administration. This medicine may also be crushed and administered through a gastrointestinal tube with a small amount of water. 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 the formation of blood clots by inhibiting blood coagulation. During the course of treatment, bleeding may occur, and signs of bleeding should be closely monitored. If severe bleeding occurs, this medication should be discontinued immediately. Patients with allergic reactions to this medication, pregnant or breastfeeding women, patients with severe liver disease, and those with conditions that increase bleeding risk should not take this medication. Patients with impaired kidney function, those at high risk of bleeding, and those taking certain other medications should use this medication with caution. In particular, the risk of bleeding may be increased when used in combination with other anticoagulants or medications that affect blood coagulation. This medication can cause various side effects such as bleeding, anemia, gastrointestinal discomfort, skin rash, etc. Patients experiencing severe bleeding, allergic reactions, or severe rashes on the skin should consult a doctor immediately. Pregnant or breastfeeding women should not use this medication, and women of childbearing age should use appropriate contraception to avoid pregnancy while taking it. Elderly patients may have higher blood concentrations due to reduced renal function; however, dosage adjustments are generally not necessary, although the risk of bleeding may increase, so caution is advised. In case of overdose, the risk of bleeding increases, and medical personnel should be notified immediately. This medication is not removed by dialysis. Before surgery or invasive procedures, this medication should be discontinued for a period of time, and resumption should consider the risk of bleeding and the effects of this medication. Caution is needed when driving or operating machinery as drowsiness or dizziness may occur. This medication can interact with several other drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist. During the course of taking this medication, if signs or symptoms of bleeding occur, inform medical personnel immediately and it is recommended to regularly monitor bleeding risk through blood tests.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and at a temperature between 1 and 30 degrees Celsius. This way, the effectiveness of the medication can be maintained for a longer period.

Appearance

Red circular film-coated tablet with a brown tint

Package unit

30 tablets (10 tablets/PTP packaging x 3)