Megasarban Tablet 60 mg (Edoxaban Tosilate Hydrate)

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 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. (See section ‘9. Administration to Elderly Patients’ 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 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, International Normalized Ratio) 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 start this medicine when 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 when the next dose of LMWH 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 during the transition from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. (1) Oral 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. To minimize the effect of this medicine on INR measurements, measure INR before administering this medicine. 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 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. 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 when 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 when the next dose of this medicine would have been due. 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 the 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 (see section ‘9. Administration to Elderly Patients’ under Precautions for Use). 4. If you forget to take this medicine If you forget to take this medicine, take it immediately 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 is an anticoagulant that prevents blood clot formation. However, it may increase the risk of bleeding, and caution should be taken in conditions where there is a bleeding risk. In case of unexplained decreases in blood counts or blood pressure during treatment, the bleeding site must be promptly checked as life-threatening bleeding may occur. If significant bleeding occurs, discontinue the medication immediately and promptly examine the bleeding site. Patients at high risk of bleeding should be closely monitored for bleeding or anemia symptoms after taking this medication. Patients with allergies to this drug, those with serious bleeding, severe renal disease, or certain liver diseases, or those at high risk of recent bleeding should not take this medication. Additionally, this drug should not be used in combination with other anticoagulants, in patients with severe hypertension, severe mitral stenosis, or in pregnant or breastfeeding women. This drug contains lactose and should not be administered to patients with lactose intolerance. Caution should be exercised when taken with drugs that increase bleeding risk, such as acetylsalicylic acid, antiplatelet agents, or non-steroidal anti-inflammatory drugs. Patients with impaired liver or kidney function should also be carefully dosed. This medication may cause side effects such as bleeding, anemia, skin rash, liver function abnormalities, so if symptoms occur, medical personnel should be informed immediately. In particular, if respiratory distress or symptoms of lung disease occur, the medication should be discontinued and treated promptly. If undergoing surgery or invasive procedures, the medication should be discontinued to reduce bleeding risk, and should be resumed only when there is no further bleeding risk after the procedure. Patients undergoing central nervous system anesthesia are at risk of hematoma development and need special care. Abrupt discontinuation of this medication may increase the risk of thrombosis, so dosing should be adjusted according to physician's instructions. Pregnant or breastfeeding women should not take this medication and women of childbearing age should consult their physician regarding pregnancy plans. Elderly patients or those with declining kidney function may require dosage adjustments and should follow the instructions of medical personnel. Overdosing on this medication increases the risk of bleeding, so dosage should be strictly followed, and in case of overdose, immediate hospital visit is necessary. This medication is difficult to accurately monitor its efficacy through coagulation tests, hence regular clinical evaluation is important. This medication does not significantly affect driving or the operation of machinery, but caution should be exercised if there are symptoms of bleeding or dizziness.

Hemorrhage, soft tissue bleeding, epistaxis, vaginal bleeding, anemia, rash, abnormal liver function tests, thrombocytopenia, hypersensitivity, anaphylactic reaction, allergic edema, dizziness, headache, intracranial hemorrhage, subarachnoid hemorrhage, conjunctival/scleral hemorrhage, intraocular hemorrhage, pericardial hemorrhage, other hemorrhage, hemoptysis, abdominal pain, lower gastrointestinal bleeding, upper gastrointestinal bleeding, oral/pharyngeal bleeding, nausea, retroperitoneal bleeding, increased bilirubin in the blood, increased gamma-glutamyltransferase, increased alkaline phosphatase in the blood, increased transaminases, increased aspartate aminotransferase, pruritus, urticaria, intramuscular bleeding, intra-articular bleeding, gross hematuria/urethral bleeding, anticoagulant-related nephropathy, bleeding at the puncture site, abnormal liver function tests, bleeding at the surgical site, subdural hemorrhage, bleeding during procedure, interstitial lung disease, shortness of breath, dyspnea, cough, fever, abnormal breath sounds, severe uterine hemorrhage, menstrual bleeding, pallor, unexplained edema, dyspnea, unexplained shock, compartment syndrome, acute kidney injury due to decreased perfusion, anticoagulant-related nephropathy

This medication should be stored in a tightly closed container to protect it from air and moisture, at room temperature between 1 degree and 30 degrees Celsius. Proper storage ensures the safety of the medication’s effectiveness.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets per bottle