Samsung Edoxaban Tablets 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 Precautions for Use, ‘9. Administration to the Elderly’) 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 ≤ 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 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, International Normalized Ratio) 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 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 during the transition from this medicine to a vitamin K antagonist. Adequate anticoagulant effect must be maintained continuously during the transition 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 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 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 (see Precautions for Use, ‘9. Administration to the Elderly’). 4. If you forget to take this medicine If you forget to take this medicine, 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. 5. Patients who cannot swallow tablets For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with a liquid such as water or applesauce, and administered orally. Alternatively, this medicine may 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 for up to 4 hours in water and applesauce.

This medicine is an anticoagulant that prevents clot formation by inhibiting blood coagulation. However, taking this medicine can increase the risk of bleeding, so careful monitoring is required if there are any bleeding tendencies or symptoms of bleeding. In particular, if there is an unexplained decrease in blood counts or a drop in blood pressure, the bleeding site should be examined immediately. If there is significant bleeding, this medicine should be discontinued and the bleeding site should be promptly treated. This medicine is generally not recommended for patients with certain conditions or diseases. For example, patients with severe bleeding, severely impaired renal function, severely compromised liver function, or those with a recent history of cerebral hemorrhage or gastrointestinal ulcers should not use this medicine. Also, using it in conjunction with other anticoagulants significantly increases the risk of bleeding, so concomitant use should be avoided. During the treatment with this medicine, care must be taken when taking medications that can increase the risk of bleeding, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, and selective serotonin reuptake inhibitors (SSRIs). Pregnant or breastfeeding women should avoid using this medicine, and women of childbearing age should consult with a physician regarding pregnancy plans. Elderly patients or those with reduced renal function may require dosage adjustments, so they should follow their physician's instructions. It is important to have regular checks on liver and kidney function during the treatment. If surgery or invasive procedures are planned, this medicine should be discontinued for a certain period to reduce the risk of bleeding, and medication may be resumed after confirming that bleeding has stopped post-procedure. This medicine poses a serious risk of bleeding in cases of overdose, so it is essential to adhere strictly to the prescribed dosage and not to discontinue or increase the dose arbitrarily without a physician's directive. Monitoring of anticoagulation effects is generally not necessary through blood coagulation tests; however, in cases of overdose or emergencies, specialized testing can be used to assess anticoagulant effects. Driving or operating machinery is not significantly affected, but caution should be taken in case of symptoms of bleeding or dizziness. It is important to consult healthcare providers immediately if any unusual symptoms occur during the treatment.

Hemorrhage, 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 hemorrhages, nasal hemorrhage, hemoptysis, abdominal pain, lower gastrointestinal hemorrhage, upper gastrointestinal hemorrhage, oral/pharyngeal hemorrhage, nausea, retroperitoneal hemorrhage, increased serum bilirubin, increased gamma-glutamyltransferase, increased serum alkaline phosphatase, increased transaminases, increased aspartate aminotransferase, skin soft tissue hemorrhage, itching, urticaria, intramuscular hemorrhage, intra-articular hemorrhage, gross hematuria/urethral hemorrhage, anticoagulant-related nephropathy, vaginal hemorrhage, hemorrhage at puncture site, abnormal liver function tests, surgical site hemorrhage, subdural hemorrhage, hemorrhage during procedure, interstitial lung disease, worsening or prolonged menstrual bleeding, weakness, pallor, unexplained edema, dyspnea, unexplained shock, compartment syndrome, renal failure due to decreased perfusion

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is best to keep the medication at room temperature, between 1°C and 30°C, avoiding places that are too hot or too cold.

Appearance

Yellow round film-coated tablets

Package unit

28 tablets/box