Samsung Edoxaban 30 Milligrams (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 P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) For 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 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 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 an oral anticoagulant other than a vitamin K antagonist (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 UFH infusion 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 Inadequate anticoagulation may occur when switching from this medicine to a vitamin K antagonist. Adequate anticoagulant effect should be maintained continuously while switching 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 the INR be measured at least 3 times; measurements should be taken before administering this medicine to minimize its effect on the INR measurement. 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 an oral anticoagulant other than a vitamin K antagonist (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 required 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 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 < 30 mL/min. 4. If you miss a dose of this medicine If you miss a dose, take this medicine 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 who cannot swallow tablets For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with a beverage such as water or applesauce, and administered orally. Alternatively, this medicine may be crushed, suspended in a small amount of water, and administered through a nasogastric tube, followed by flushing the tube with water. Crushed this medicine is stable in water and applesauce for up to 4 hours.

This medication is an anticoagulant that prevents thrombosis. However, taking this medication may increase the risk of bleeding, so patients with a risk of bleeding should use it with special caution. Serious bleeding may occur, requiring immediate consultation with healthcare providers and rapid examination of any possible bleeding sites. Patients with a high risk of bleeding should carefully monitor for symptoms of bleeding and anemia after taking this drug. Patients allergic to this drug, with severe bleeding, severely impaired kidney function, severe liver disease, multiple diseases that increase bleeding risk, as well as pregnant or nursing women should not take this medication. Moreover, concurrent use with other anticoagulants should be avoided, and caution is recommended for patients with uncontrolled hypertension or certain heart conditions. This drug requires special caution when used with other medications that can increase the risk of bleeding. Specifically, the risk of bleeding can be increased when combined with aspirin, antiplatelet agents, non-steroidal anti-inflammatory drugs, and selective serotonin reuptake inhibitors. Patients with weak kidney and liver function must undergo function tests before taking this medication, and regular monitoring is necessary during treatment. The use of this drug should be stopped before undergoing surgery or invasive procedures, and it should only be resumed after confirming that hemostatic status is satisfactory post-procedure. This medication is not to be administered to pregnant or nursing women, and women planning to become pregnant should consult a physician before taking it. Elderly patients or those with impaired kidney function may require dosage adjustments. This medication may affect blood coagulation test results, but its effects are difficult to accurately assess with standard coagulation tests. Overdosing increases the risk of bleeding, so the dosage must be strictly followed, and appropriate measures such as activated charcoal may be required in the event of an overdose. Patients should inform healthcare providers immediately if symptoms such as bleeding, dizziness, pallor, severe headache, or respiratory distress occur during treatment.

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

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink round film-coated tablets

Package unit

28 tablets/box