Idong Edoxaban 60 mg (Edoxaban besilate hydrate)

Adult dose

Take this medicine with water, with or without food. 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 is 30mg once daily. Moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) Concomitant use of P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) For older adults at high risk of bleeding, 15mg once daily may be administered according to 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 parenteral anticoagulant use. 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 is 30mg once daily. Moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) Concomitant use of P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) 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 Low-molecular-weight heparin (LMWH): Discontinue LMWH and start this medicine at the time of the next scheduled LMWH dose. Unfractionated heparin (UFH): Discontinue the intravenous UFH infusion and start this medicine 4 hours later. 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, and measurements should be taken before administration of this medicine to minimize its effect on the INR measurement. Once an INR ≥ 2.0 is stably achieved, discontinue this medicine and continue vitamin K antagonist therapy. Discontinue this medicine and, at the time of the next scheduled dose of this medicine, administer a parenteral anticoagulant and a vitamin K antagonist. Once an 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. No dosage adjustment is necessary in patients with mild renal impairment (50 < CrCL ≤ 80mL/min). The recommended dose 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, in older adults at high risk of bleeding and with a creatinine clearance of 15 ≤ CrCL < 30mL/min, administration of 15mg once daily should be considered according to age and condition. If a dose of this medicine is missed, take it immediately on the same day and take the next dose according to the recommended dosage and administration. Do not take twice the recommended daily dose to make up for a missed dose.

This medication is an anticoagulant that thins the blood to prevent clot formation. Taking this medication may increase the risk of bleeding, so patients at high risk for bleeding should exercise caution. If bleeding is suspected or there is unexplained drops in blood counts or blood pressure, the bleeding site should be checked immediately. If severe bleeding occurs, the medication should be discontinued, and the bleeding site should be examined promptly. Patients at high risk of bleeding should be monitored closely for signs of bleeding and anemia. This medication should not be given to patients with certain conditions. For instance, those who are allergic to the components of this medication, those with clinically significant bleeding, patients with end-stage kidney disease, and those with severe liver dysfunction should not take this medication. Additionally, patients with a history of recent gastrointestinal ulcers, intracranial hemorrhage, brain surgeries, or clotting disorders should avoid it. Pregnant and breastfeeding women are also prohibited from taking this medication. The risk of bleeding may increase when this medication is taken with other drugs that affect hemostasis, such as aspirin, antiplatelet agents, non-steroidal anti-inflammatory drugs, or selective serotonin reuptake inhibitors, so caution is needed. Furthermore, patients with specific liver diseases or impaired renal function should be administered this medication cautiously. During treatment with this medication, if symptoms of bleeding, such as easy bruising, nosebleeds, gum bleeding, hematuria, blood in the stool, vaginal bleeding, severe headaches, or dizziness occur, consult a physician immediately. Emergency intervention may be required in severe cases. This medication can also lead to rare side effects like interstitial lung disease; therefore, if symptoms such as shortness of breath, cough, or fever occur, inform medical personnel immediately. Before undergoing surgery or invasive procedures, it is crucial to inform healthcare providers about taking this medication, and if necessary, the medication should be stopped prior to the procedure. After the procedure, the medication should be reinstated at the appropriate time to reduce the risk of bleeding. This medication should not be taken by women during pregnancy or breastfeeding, and women of reproductive age should discuss pregnancy plans with their physician. Elderly patients or those with reduced kidney function may need adjusted doses, so they should take this medication under a doctor's guidance. Overdose significantly increases the risk of bleeding, so it's vital to adhere to the prescribed dose, and in case of overdose, seek hospital care immediately. There is no antidote for this medication, so specialized treatment is necessary in case of overdose. While taking this medication, results from blood coagulation tests may vary, but regular clotting tests may not accurately monitor the effects of this medication. Therefore, periodic blood tests are conducted based on the physician's judgment. This medication may have minimal effects on driving or operating machinery, but caution should be exercised if symptoms like bleeding or dizziness occur.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Avoid storing in areas that are too hot or cold, and it is safest to store it at room temperature between 1°C and 30°C.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle