Idong Edoxaban Tablets 30mg (Edoxaban Betylate Hydrate)

Adult dose

This medicine should be administered with water, with or without food. 1. Adults 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Body weight ≤ 60kg: The recommended dose of this medicine is 30mg once daily. Body weight > 60kg: The recommended dose of this medicine is 60mg once daily. However, in patients with one or more of the following factors, the recommended dose of this medicine is 30mg once daily. Moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) Concomitant use of P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) In elderly patients at high risk of bleeding, a dose of 15mg once daily may be administered depending on age and condition. 2) Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Administer this medicine after at least 5 days of treatment with a parenteral anticoagulant. Body weight ≤ 60kg: The recommended dose of this medicine is 30mg once daily. Body weight > 60kg: The recommended dose of this medicine is 60mg once daily. However, in patients with one or more of the following factors, the recommended dose of this medicine is 30mg once daily. Moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) Concomitant use of P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) 2. Switching medications 2.1 Switching from another medication to this medicine 1) Switching from a vitamin K antagonist to this medicine Discontinue vitamin K antagonist therapy and initiate this medicine when the International Normalized Ratio (INR) is ≤ 2.5. 2) Switching from a non-vitamin K antagonist oral anticoagulant (dabigatran, rivaroxaban, apixaban) to this medicine Discontinue oral anticoagulant therapy and initiate this medicine at the time of the next scheduled dose of the oral anticoagulant. 3) Switching from a parenteral anticoagulant to this medicine (1) Low-molecular-weight heparin (LMWH) Discontinue LMWH and initiate this medicine at the time of the next scheduled LMWH dose. (2) Unfractionated heparin (UFH) Discontinue the intravenous infusion of UFH and initiate this medicine 4 hours later. 2.2 Switching from this medicine to another medication 1) Switching from this medicine to a vitamin K antagonist For patients receiving 60mg of this medicine, administer 30mg of this medicine once daily together with an appropriate dose of a vitamin K antagonist. For patients receiving 30mg of this medicine, administer 15mg of this medicine once daily together with an appropriate dose of a vitamin K antagonist. During the first 14 days of concomitant administration, it is recommended that INR be measured at least 3 times. To minimize the effect of this medicine on INR measurements, measure INR before administering this medicine. Once INR ≥ 2.0 is stably achieved, discontinue this medicine and continue vitamin K antagonist therapy. Discontinue this medicine and administer a parenteral anticoagulant and a vitamin K antagonist at the time of the next scheduled dose of this medicine. Once INR ≥ 2.0 is stably achieved, discontinue the parenteral anticoagulant and continue vitamin K antagonist therapy. 2) Switching from this medicine to a non-vitamin K antagonist oral anticoagulant (dabigatran, rivaroxaban, apixaban) Discontinue this medicine and initiate the oral anticoagulant at the time of the next scheduled dose of this medicine. 3) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and initiate the parenteral anticoagulant at the time of the next scheduled dose of this medicine. 3. Patients with renal impairment No dose adjustment of this medicine is necessary in patients with mild renal impairment (50 < CrCL ≤ 80mL/min). The recommended dose of this medicine in patients with moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) is 30mg once daily. For reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, administration of 15mg once daily should be considered, depending on age and condition, in elderly patients at high risk of bleeding with creatinine clearance of 15 ≤ CrCL < 30mL/min (see section ‘9. Use in elderly patients’ under Precautions for Use). 4. If you forget to take this medicine If you forget to take this medicine, take it immediately on the same day, and take the next dose the following day according to the recommended dosage and administration. Do not take twice the recommended daily dose to make up for a missed dose.

This medication can increase the risk of bleeding, so caution should be exercised in patients who bleed easily or are in situations with a high risk of bleeding. If a life-threatening bleed occurs, stop taking this medication immediately and promptly examine the bleeding site. Patients with a high risk of bleeding should carefully monitor for signs of bleeding or anemia after taking this medication. It should not be used in patients who are allergic to this medication or have serious bleeding, end-stage kidney disease, severe liver disease, or certain bleeding risk conditions. Caution is also needed when taken with other anticoagulants, especially in patients with uncontrolled hypertension or severe heart disease. This medication should not be given to pregnant or breastfeeding women, and women who may become pregnant should avoid pregnancy while taking it. Extra caution is required when combined with other drugs that may increase bleeding risk (e.g., aspirin, antiplatelet agents, non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors). While taking this medication, it is important to regularly monitor liver and kidney function, and if kidney function worsens, consult a medical professional immediately. This medication should be discontinued before any surgical or invasive procedures and sufficient consideration should be given to the risk of bleeding when starting it again after the procedure. Effectiveness is generally not monitored through blood clotting tests, but special tests may be needed in cases of overdose or emergencies. Overdose significantly increases the risk of bleeding, so immediate medical assistance should be sought, and there is no antidote for this medication. Elderly patients or those with impaired kidney function may need dosage adjustments, so it should be taken according to a physician's instructions. Any unusual symptoms such as dizziness, headache, skin rash, or bleeding should be reported to a healthcare provider immediately.

• Hemorrhage
• soft tissue hemorrhage
• nasal bleeding
• vaginal bleeding
• anemia
• rash
• abnormal liver function tests
• thrombocytopenia
• hypersensitivity
• anaphylactic reaction

This medication should be stored in a tightly closed container to protect it from air and moisture. It is also important to store it at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle