Megasaban Tablet 30 mg (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 considered depending on their age and condition. 2) Treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent 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, 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 start this medicine when the International Normalized Ratio (INR) is 2.5 or less. 2) Switching from an oral anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, apixaban) to this medicine Discontinue oral anticoagulant therapy and start this medicine at the time the next dose of the oral anticoagulant would have been due. 3) Switching from a parenteral anticoagulant to this medicine (1) Low-molecular-weight heparin (LMWH) Discontinue LMWH and start this medicine at the time the next LMWH dose would have been due. (2) Unfractionated heparin (UFH) Discontinue the intravenous UFH infusion and start 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 while switching from this medicine to a vitamin K antagonist. Adequate anticoagulant effects should be maintained continuously during the switch to another anticoagulant. Option For patients taking 60mg of this medicine, administer 30mg of this medicine once daily together with an appropriate dose of a vitamin K antagonist. For patients taking 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. Option Discontinue this medicine and administer a parenteral anticoagulant and a vitamin K antagonist at the time 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. 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 the next dose of this medicine would have been due. 3) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start the parenteral anticoagulant at the time the next dose of this medicine would have been due. 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 the 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 < 30mL/min (see section ‘9. Administration to elderly patients’ in 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 it 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.

This medication may increase the risk of bleeding, which can lead to severe hemorrhage, thus special caution is required for patients at high risk of bleeding. If bleeding symptoms appear, immediate discontinuation of this medication is required, and the bleeding site must be examined promptly. It should not be administered to patients with hypersensitivity or clinically significant bleeding, or those with severe renal or liver dysfunction. Patients with a recent history of gastrointestinal ulcer, intracerebral hemorrhage, or surgical history involving the brain or spinal cord may also be at risk when using this medication. When used in combination with other anticoagulants, the risk of bleeding is further increased, so combinations should be avoided or used strictly under medical supervision. Caution is also needed when used concurrently with drugs that affect bleeding such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs, antiplatelet agents, and selective serotonin reuptake inhibitors. This medication should not be given to pregnant or breastfeeding women, and women of childbearing age should consult a physician about pregnancy plans. Elderly patients or those with reduced renal function may require dosage adjustments, and regular monitoring of liver and kidney function is recommended. If undergoing surgery or invasive procedures, this medication should be discontinued for a certain period to reduce the risk of bleeding, and it should be resumed only after confirming hemostasis following the procedure. Since monitoring the effects of this medication by general coagulation tests is difficult, appropriate tests should be conducted as directed by a physician. In case of overdose, the risk of bleeding is greatly increased, so the recommended dosage must be strictly adhered to, and in cases of suspicion, medical personnel should be informed immediately.

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

This medication should be stored in a tightly closed container to prevent air and moisture from entering, and it is recommended to keep it at temperatures between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medication for a longer time.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle