Shin Poong Edoxaban Tablets 30mg (Edoxaban Tosilate Monohydrate)

Adult dose

This medicine should be taken with water, regardless of meals. 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, 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 administered depending on age and condition. (Refer to “9. Administration to the Elderly” under Precautions for Use.) 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 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 medicine to this medicine 1) Switching from a vitamin K antagonist to this medicine Discontinue vitamin K antagonist treatment and start 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 treatment 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 the intravenous UFH infusion and start this medicine 4 hours later. 2.2 Switching from this medicine to another medicine 1) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur while 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 treatment. (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 treatment. 2) Switching from this medicine to an oral anticoagulant other than a vitamin K antagonist (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 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. (Refer to “9. Administration to the Elderly” under Precautions for Use.) 4. If you forget to take this medicine If you forget to take 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. 5. Patients who cannot swallow tablets 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; flush the nasogastric tube with water afterward. Crushed this medicine is stable in water and applesauce for up to 4 hours.

This medication is an anticoagulant that helps thin the blood and prevent blood clots. When using this medication, be cautious as the risk of bleeding may increase. Bleeding can occur in any part of the body, and if there is an unexplained drop in blood levels or blood pressure, the bleeding site must be checked. If severe bleeding occurs, stop administering this medication immediately and promptly investigate the bleeding site. Patients with a high risk of bleeding should be closely monitored for bleeding or anemia symptoms after starting this medication. This medication should not be used in certain patients, including those with allergies to its ingredients, those with clinically significant bleeding, individuals with end-stage renal disease, those with bleeding disorders or severe liver dysfunction, and those with recent histories of gastrointestinal ulcers or intracranial hemorrhage. Additionally, it should not be administered in combination with other anticoagulants or to those with uncontrolled hypertension, severe mitral stenosis, or pregnant or breastfeeding women. When using this medication with other drugs, be cautious of interactions. In particular, when combined with antiplatelet agents, non-steroidal anti-inflammatory drugs, certain antibiotics, antifungals, and antivirals, the risk of bleeding may increase. Patients with impaired liver or renal function should undergo testing before administration of this medication and regularly while on treatment to monitor their condition. Before surgery or invasive procedures, it may be necessary to discontinue this medication for a certain period to reduce the risk of bleeding, and it should be resumed immediately once hemostasis is stable post-procedure. This medication does not typically require monitoring of blood coagulation tests for effectiveness, but in cases of excessive bleeding or emergencies, specialized testing can be used to assess its effects. Pregnant or breastfeeding women should not use this medication, and women of childbearing potential should discuss their pregnancy plans with their doctors. Elderly patients, those with impaired kidney function, and patients with low body weight may require dosage adjustments. Overdosing on this medication increases the risk of bleeding, so if an overdose occurs, contact a healthcare facility immediately for appropriate measures. Finally, this medication generally has little effect on driving or operating machinery; however, caution is advised if there are symptoms of bleeding or dizziness.

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

This medication may be sensitive to air or humidity, so it should be stored in a sealed container. Additionally, it is best to store it at a temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance

Pink round film-coated tablet

Package unit

28 tablets/box