Edoxaban Tablets 30 mg (Edoxaban Tosilate Hydrate)

Adult dose

This medicine should be taken with water, regardless of meals. 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. 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 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 P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) For elderly patients at high risk of bleeding, a dose of 15mg once daily may be administered according to age and condition. 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 use. Treatment of deep vein thrombosis and pulmonary embolism/Reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism: Body weight ≤ 60kg : The recommended dose of this medicine is 30mg once daily. Treatment of deep vein thrombosis and pulmonary embolism/Reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism: 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 P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) Discontinue vitamin K antagonist therapy and start this medicine when the international normalized ratio (INR, International Normalized Ratio) is 2.5 or less. Discontinue oral anticoagulant therapy and start this medicine at the time of the next scheduled dose of the oral anticoagulant. Discontinue LMWH and start this medicine at the time of the next scheduled dose of LMWH. Discontinue intravenous UFH infusion and start this medicine 4 hours later. 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 measurement. 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. Discontinue this medicine and start oral anticoagulant therapy at the time of the next scheduled dose of this medicine. Discontinue this medicine and start parenteral anticoagulant therapy at the time of the next scheduled dose of this medicine. No dose adjustment of this medicine is necessary in patients with mild renal impairment (50 < CrCL ≤ 80mL/min). For patients with moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min), the recommended dose of this medicine is 30mg once daily. For elderly patients at high risk of bleeding with creatinine clearance of 15 ≤ CrCL < 30 mL/min, a dose of 15mg once daily should be considered for reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, according to age and condition. If you miss a dose of this medicine, take it as soon as possible on the same day, and take the next day's dose according to the recommended dosage and administration. Do not take twice the recommended daily dose to make up for a missed dose. For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as applesauce, and administered orally. Alternatively, this medicine may be crushed, suspended in a small amount of water, and administered through a nasogastric tube, after which water should be flushed through the tube. Crushed this medicine is stable in water and applesauce for up to 4 hours.

This medication prevents the clotting of blood, thereby preventing thrombus formation. However, taking this medication may increase the risk of bleeding, so caution is necessary. Patients at high risk for bleeding should be especially careful when using this medication, and if signs of bleeding or anemia occur during treatment, immediate reporting to healthcare personnel is necessary. This medication should not be administered to certain patients, such as those with significant bleeding, severe kidney or liver diseases, pregnant women, or breastfeeding women. Moreover, caution is required when taking this medication in conjunction with other drugs that can increase bleeding risk (e.g., aspirin, antiplatelet agents, non-steroidal anti-inflammatory drugs, certain antidepressants). Patients taking this medication should have regular checks of liver and kidney function, and adhere to medical personnel's instructions regarding discontinuing the medication before surgeries or invasive procedures. If bleeding symptoms occur, the medication should be discontinued immediately, and if necessary, appropriate measures such as hemostatic treatment or blood transfusion should be taken. This medication is not recommended for use in pregnant or breastfeeding women, and women of childbearing age should consult with a doctor about pregnancy plans. Elderly patients or those with reduced kidney function may need dose adjustments, and they should discuss this with their healthcare provider. Taking this medication in excess can greatly increase the risk of bleeding, so it is essential to adhere to the prescribed dosage and regimen. Lastly, the effects of this medication are difficult to monitor accurately with routine blood coagulation tests; therefore, regular checks should be conducted as directed by a doctor.

• Bleeding
• anemia
• rash
• abnormal liver function tests
• thrombocytopenia
• hypersensitivity
• anaphylactic reaction
• allergic swelling
• dizziness
• headache

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and should be kept at room temperature between 1 and 30 degrees Celsius. Storing under these conditions can help maintain the medication's effectiveness for a long time.

Appearance

Pink round film-coated tablet

Package unit

28 tablets/box