Shinpoong Edoxaban Tablets 60mg (Edoxaban Tosilate Hydrate)

Adult dose

This medicine should be administered with water, regardless of meals. 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Body weight ≤60 kg: The recommended dose is 30mg once daily. Body weight >60 kg: The recommended dose is 60mg once daily. However, for 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) In 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 of the risk of recurrent deep vein thrombosis and pulmonary embolism Administer this medicine after at least 5 days of parenteral anticoagulant use. Body weight ≤60 kg: The recommended dose is 30mg once daily. Body weight >60 kg: The recommended dose is 60mg once daily. However, for 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) Discontinue vitamin K antagonist therapy and start this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤2.5. Discontinue oral anticoagulant therapy and start this medicine when the next dose of the oral anticoagulant would have been due. Discontinue LMWH and start this medicine when the next dose of LMWH would have been due. 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 administering 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 vitamin K antagonist when the next dose of this medicine would have been due. 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 when the next dose of this medicine would have been due. Discontinue this medicine and start parenteral anticoagulant therapy when the next dose of this medicine would have been due. No dose adjustment is required in patients with mild renal impairment (50 < CrCL ≤ 80mL/min). The recommended dose of this medicine is 30mg once daily in patients with moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min). 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. If a dose of this medicine is missed, 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. For patients unable to swallow tablets, this medicine may be crushed immediately before use, mixed with water or a drink such as applesauce, and administered orally. It may also 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 used to prevent the formation of blood clots by thinning the blood. Taking this medication may increase the risk of bleeding, so patients should immediately check for bleeding if they experience any suspicious symptoms or low blood pressure. If serious bleeding occurs, the medication should be discontinued, and the bleeding site should be checked promptly. Patients at high risk of bleeding should be carefully monitored for signs of bleeding or anemia after taking this medication. This medication should not be used in specific patients, such as those with severely impaired kidney function, severe liver disease, patients with significant bleeding, pregnant or breastfeeding women, etc. Additionally, patients with recent gastrointestinal ulcers or a history of intracranial hemorrhage, patients with high bleeding risks due to cancer, and patients with severe hypertension should use this medication with caution. Extra caution is required when combined with other anticoagulants, antiplatelet agents, non-steroidal anti-inflammatory drugs, and certain antidepressants that may increase the risk of bleeding. This medication can affect liver and kidney function, so regular liver and kidney function tests are required before and during treatment. Before undergoing surgery or invasive procedures, this medication should be discontinued for a certain period to reduce the risk of bleeding, and it is important to resume it as soon as hemostasis is stable after surgery. This medication does not significantly impact driving or machinery operation, but caution should be exercised if bleeding symptoms or dizziness occur. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should discuss their pregnancy plans with a doctor. Elderly patients or those with reduced kidney function may require dosage adjustments, and those at high risk of bleeding may be prescribed a lower dosage. This medication can affect coagulation test results, so routine coagulation tests may not accurately assess its effects. In case of overdose, there is an increased risk of bleeding, so immediate consultation with medical personnel is needed, and since there is no antidote for this medication, emergency care may be required. Finally, if unusual symptoms such as bleeding symptoms, anemia symptoms, shortness of breath, severe headaches appear while taking this medication, immediate medical attention should be sought.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is best kept at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy and prevents deterioration.

Appearance

Yellow, round, film-coated tablet

Package unit

28 tablets/box