Eliquis 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 the 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. 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 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 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 during the remainder of treatment. 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. Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at once. Starting the following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the following day, continue taking 1 tablet once daily. The daily dose should not be doubled to make up for a missed dose. This medicine should be started after discontinuing vitamin K antagonist therapy and when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. This medicine should be started after discontinuing vitamin K antagonist therapy and 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. Inadequate anticoagulation may occur when 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 the vitamin K antagonist concomitantly 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 dose of the vitamin K antagonist according to INR test results. In contrast, patients receiving this medicine concomitantly with a vitamin K antagonist should not undergo INR testing until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR testing may be performed 24 hours after the last dose. 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). Discontinue this medicine and start the parenteral anticoagulant at the time the next dose of this medicine would have been due. No dose adjustment is necessary in patients with mild renal impairment and 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 were significantly increased; 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, as there is no clinical experience in these patients. Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose in 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. 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). 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. 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 with a small amount of water through a gastrointestinal tube. Before administering this medicine through a gastrointestinal tube, confirm that the tube is properly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat blood clots by inhibiting blood coagulation. During the course of taking this medication, bleeding may occur, so it's essential to closely monitor for any signs or symptoms of bleeding. If severe bleeding occurs, the use of this medication should be immediately stopped and you should consult a physician. This medication is contraindicated for certain diseases or conditions, for example in patients with severe existing bleeding, severely impaired liver function, pregnant or breastfeeding women, and those with lactose intolerance. Patients with a history of gastrointestinal bleeding, intracranial bleeding, vascular abnormalities, recent surgery, or trauma also need to use this medication with caution. Combining this medication with other anticoagulants or certain antifungals may increase the risk of bleeding, so such combinations should be avoided or done with caution. In patients with impaired kidney function or conditions that increase the risk of bleeding, this medication should be used carefully, weighing the bleeding risks against the therapeutic benefits. If symptoms of bleeding, anemia, dizziness, headaches, or difficulty breathing occur during treatment, notify healthcare professionals immediately. Before any surgery or invasive procedures, the timing and method of discontinuing this medication should be discussed with a physician, and measures should be taken to reduce bleeding risk. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication and should use contraception while taking it. Elderly patients may experience increased drug concentration due to reduced kidney function; however, dose adjustment is generally not required, but bleeding risk may be increased. In cases of overdose, contact healthcare professionals immediately and monitor for symptoms of bleeding; appropriate treatment should be initiated if necessary. Caution is required while driving or operating machinery, as this medication may cause drowsiness or fainting. This medication may interact with various drugs, so inform your physician or pharmacist about any other medications being taken.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance

Round film-coated tablet colored reddish-brown

Package unit

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