Uneducted 60mg (Edoxaban Tosilate Hydrate)

Adult dose

This medicine should be taken with water, with or without food. 1. Adults 1) Reduction in 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, for 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 a P-gp inhibitor (cyclosporine, dronedarone, erythromycin, ketoconazole) For elderly patients at high risk of bleeding, a dose of 15mg once daily may be used depending on age and condition. (See “9. Administration to Elderly Patients” under Precautions for Use.) 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism Administer this medicine after at least 5 days of parenteral anticoagulant therapy. • 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, for 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 a P-gp inhibitor (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 start 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 start 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 start this medicine at the time of the next scheduled LMWH dose. (2) Unfractionated heparin (UFH) Discontinue intravenous UFH infusion and start this medicine 4 hours later. 2.2 Switching from this medicine to another medication 1) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur when switching from this medicine to a vitamin K antagonist. Adequate anticoagulant effect should be maintained continuously during the switch to another anticoagulant. (1) Oral option 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; measurements should be taken before administration of this medicine to minimize its effect on INR measurements. Once INR ≥ 2.0 is stably achieved, discontinue this medicine and continue vitamin K antagonist therapy. (2) Parenteral option 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 start 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 start the parenteral anticoagulant at the time of the next scheduled dose of this medicine. 3. Patients with renal impairment No dose adjustment is necessary for patients with mild renal impairment (50 < CrCL ≤ 80mL/min). The recommended dose of this medicine for patients with moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) is 30mg once daily. For the reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a dose of 15mg once daily should be considered, depending on age and condition, for elderly patients at high risk of bleeding with creatinine clearance of 15 ≤ CrCL < 30mL/min (see “9. Administration to 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. 5. Patients unable to swallow tablets For patients unable to swallow tablets, this medicine may be crushed and mixed with water or a beverage such as applesauce for oral administration immediately before use. Alternatively, this medicine may be crushed, suspended in a small amount of water, and administered through a nasogastric tube; flush the tube with water afterward. Crushed this medicine is stable in water and applesauce for up to 4 hours.

This medication prevents blood clots from forming by inhibiting coagulation. However, taking this medication can significantly increase the risk of bleeding, so patients at high risk of bleeding should exercise special caution. If there are symptoms suggesting bleeding or if blood pressure suddenly drops, one must immediately check for the bleeding source at a hospital. In the event of serious bleeding, the use of this medication must be discontinued and the bleeding site urgently investigated. Patients at high risk of bleeding should closely monitor symptoms of bleeding and anemia after starting this medication. This medication should not be taken by patients with known allergies, those who are already experiencing significant bleeding, or those with severe kidney or liver disease. Additionally, patients with high-risk bleeding conditions such as recent gastric ulcers, intracranial hemorrhage, or severe hypertension should also avoid using this medication. Co-administration with other anticoagulants increases the risk of bleeding, so such combinations should be avoided. Caution is advised when taking aspirin, non-steroidal anti-inflammatory drugs, antiplatelet agents, and certain antidepressants in conjunction with this medication, as it may further increase the risk of bleeding. Regularly check liver and kidney functions to ensure there are no abnormalities during treatment. Discontinue this medication at least 24 hours prior to any surgical or invasive procedures, and the timing of re-administration post-procedure should consider the risk of bleeding. Special care must be taken when receiving central nervous system anesthesia or spinal taps due to the risk of nerve damage from bleeding. Abruptly stopping this medication can increase the risk of thrombosis, so it should not be discontinued without consulting a physician. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should consult a physician regarding pregnancy plans. Elderly patients or those with impaired kidney function may require dosage adjustments, so they should follow medical advice. This medication can prolong clotting times in blood tests, but it is difficult to accurately monitor the effect of the drug with standard clotting tests. In the case of overdose, the risk of bleeding is significantly high, so immediate contact with a medical facility is required for necessary treatment. Report any signs of bleeding or adverse reactions that occur during the course of this medication to the medical staff immediately.

• Hemorrhage
• anemia
• rash
• abnormal liver function tests
• thrombocytopenia
• hypersensitivity
• anaphylactic reaction
• allergic edema
• dizziness
• headache

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, ideally at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a long time.

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/box