Edoxaban 15 mg Tablet

Adult dose

This medicine 10 mg may be taken with or without food, while 15 mg and 20 mg should be taken with food. 1. Adults 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose of this medicine is 20 mg once daily. The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) is 15 mg once daily. The maximum daily dose of this medicine is 20 mg. There is limited experience with concomitant administration of rivaroxaban 15 mg once daily [10 mg once daily for patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] and a P2Y12 inhibitor for up to 12 months in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement. (See '12. Clinical Trial Information') 2) Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended initial dose of this medicine for the treatment of acute deep vein thrombosis and pulmonary embolism is 15 mg twice daily for the first 3 weeks. Thereafter, the recommended maintenance dose for the treatment of deep vein thrombosis and pulmonary embolism and the recommended dose for reducing the risk of recurrence are 20 mg once daily. After completion of treatment (at least 6 months) for deep vein thrombosis or pulmonary embolism, the recommended dose for extended treatment to reduce the risk of recurrence is 10mg once daily. The duration and dose of treatment should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism in relation to the risk of bleeding. Treatment period Frequency of administration Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21 15mg twice daily 30mg From day 22 20mg once daily 20mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism After at least 6 months of treatment 10mg once daily 10mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. 3) Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement) The recommended dose of this medicine is 10 mg once daily. The initial dose should be started 6~10 hours after surgery, once hemostasis has been established. The duration of treatment depends on each patient's risk of venous thromboembolism according to the type of surgery; however, a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. 4) If you miss a dose of this medicine If you miss a dose of this medicine, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at one time. Starting the next day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the next day, continue taking one tablet once daily. The daily dose must not be doubled to make up for a missed dose. 2. Switching medicines 1) Switching from a vitamin K antagonist to this medicine ① Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist treatment and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Discontinue vitamin K antagonist treatment and start taking this medicine when the INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this medicine. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medicine. 2) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this medicine may affect the increase in INR. Patients switching from this medicine to a vitamin K antagonist should take the vitamin K antagonist concomitantly until the INR is ≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer a dose based on INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this medicine. Once this medicine is discontinued, INR testing can be performed 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine For patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low molecular weight heparin), or at the time the continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 4) 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 is necessary in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the blood concentration of this medicine increased significantly; therefore, this medicine should be administered with caution. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min because there is no clinical experience in these patients. 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) and severe renal impairment (creatinine clearance 15-29 mL/min) is 15 mg once daily. 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism / prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement) No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 5. Patients who cannot swallow tablets, Immediately before use, this medicine may be crushed and mixed with water or a beverage such as applesauce and administered orally. This medicine may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this medicine through a gastrointestinal tube, confirm that the tube is correctly positioned, and flush the tube with water after administration.

This drug is an anticoagulant that prevents blood clotting. During treatment, bleeding may occur, so careful observation for signs or symptoms of bleeding is necessary. If severe bleeding occurs, discontinue the medication immediately and consult a physician. This medication should not be administered to certain patients. For instance, patients with an allergy to this drug or its components, those who are already experiencing significant bleeding, patients with severe liver dysfunction, women who are pregnant or breastfeeding, and patients with lactose intolerance should not take this medication. Patients at high risk of bleeding, those with impaired kidney function, and those on certain medications or with specific diseases should use this drug with caution and manage their dosage and condition under a physician's guidance. Care should be taken when using this drug in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors, and other anticoagulants, as the risk of bleeding may increase. Various adverse reactions may occur during treatment, with the most common being bleeding and anemia. Bleeding may present in various forms such as gum bleeding, nosebleeds, gastrointestinal bleeding, and hematuria. Symptoms like rash, itching, liver dysfunction, headaches, and dizziness have also been reported. This drug can harm a fetus during pregnancy, so pregnant women should avoid taking it, and women who could become pregnant should ensure proper contraception during treatment. Nursing mothers are also advised to avoid taking this medication. Elderly patients may experience increased blood concentration due to decreased kidney function, though specific dose adjustments are not necessary, they should be careful as the risk of bleeding may increase. In the case of overdose, bleeding complications may occur, and appropriate medical treatment should be sought immediately. This drug is not eliminated by hemodialysis, so methods to reduce absorption such as activated charcoal may be considered in cases of overdose. This drug interacts with specific antifungal agents, antiviral agents, and antibiotics, potentially altering blood concentration levels, thus informing a physician or pharmacist is crucial if the patient is taking other medications. Before surgery or invasive procedures, this medication should be discontinued for a certain period, and the timing of reinstitution after the procedure should be determined based on the risk of bleeding and the patient’s condition. There are no studies on its effect on driving or machinery operation; however, caution is necessary as dizziness or drowsiness may occur while taking this medication. If symptoms of bleeding, skin rash, severe allergic reactions, or mucosal ulcers occur during treatment, consult medical personnel immediately.

• Bleeding
• anemia
• thrombocythemia
• tachycardia
• ocular hemorrhage
• gingival bleeding
• gastrointestinal bleeding
• stomach pain
• abdominal pain
• dyspepsia

This drug should be stored in an airtight container to prevent exposure to air and moisture, ideally at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the drug's efficacy for a longer period.

Appearance

Red round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP) x 3]