Elsaban Tablet 2.5 mg (Apixaban)

Adult dose

Take this medicine with water, with or without food. If a patient misses a dose, they should take this medicine as soon as possible and continue taking it twice daily as before. 1) Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery The recommended dose is 2.5 mg of this medicine taken orally twice daily. The initial dose should be taken 12 ~ 24 hours after surgery. The recommended duration of treatment for patients who have undergone hip replacement surgery is 32 ~ 38 days. The recommended duration of treatment for patients who have undergone knee replacement surgery is 10 ~ 14 days. 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose is 5 mg of this medicine taken orally twice daily. However, the recommended dose for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics is 2.5 mg of this medicine taken orally twice daily; age≥80 years, body weight ≤60kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L). Treatment should be continued long term. There is limited experience with administering the recommended dose of this medicine together with an antiplatelet agent after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who also have acute coronary syndrome and/or have undergone percutaneous coronary intervention. (Refer to ‘5. General precautions, 1) Interactions with other drugs that affect hemostasis’ and ‘12. Clinical trial information, 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, AUGUSTUS trial’ under Precautions for Use.) 3) Treatment of deep vein thrombosis and pulmonary embolism The recommended dose of this medicine for the treatment of acute deep vein thrombosis and pulmonary embolism is 10mg orally twice daily for 7 days, followed by 5mg orally twice daily. 4) Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended dose is 2.5mg of this medicine taken orally twice daily, and treatment should be started after at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between medications When switching from parenteral anticoagulant treatment to this medicine or from this medicine to a parenteral anticoagulant, the switch can be made at the time of the next scheduled dose. 1) Switching from vitamin K antagonist treatment to this medicine To switch from vitamin K antagonist treatment to this medicine, discontinue warfarin or the other vitamin K antagonist and start this medicine when the International Normalized Ratio (INR) is less than 2.0. 2) Switching from this medicine to vitamin K antagonist treatment To switch from this medicine to vitamin K antagonist treatment, continue taking this medicine for 2 days after starting the vitamin K antagonist. After 2 days of concomitant treatment with this medicine and the vitamin K antagonist, measure the INR just before the scheduled dose of this medicine, and continue concomitant treatment with this medicine and the vitamin K antagonist until the INR is 2.0 or higher. 3. Renal impairment Use of this medicine is not recommended in patients on dialysis or in patients with creatinine clearance less than 15 mL/min because there is no clinical experience in these patients. 1) Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery No dose adjustment is necessary in patients with mild or moderate renal impairment. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine increased in these patients; therefore, this medicine should be administered with caution in these patients. 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation No dose adjustment is necessary in patients with mild or moderate renal impairment. However, patients with serum creatinine ≥1.5 mg/dL (133 micromole/L) who are aged ≥ 80 years or weigh ≤ 60kg should receive 2.5 mg of this medicine twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive 2.5 mg of this medicine twice daily, regardless of age or body weight. 3) Treatment of deep vein thrombosis and pulmonary embolism/ Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism No dose adjustment is necessary in patients with mild or moderate renal impairment. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine increased in these patients; therefore, this medicine should be administered with caution in these patients. 4. Hepatic impairment This medicine should not be administered to patients with liver disease associated with coagulopathy and a clinically significant risk of bleeding. No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child Pugh A or B), but this medicine should be administered with caution. Use of this medicine is not recommended in patients with severe hepatic impairment. Patients with hepatic ALT/AST levels exceeding 2 times the upper limit of normal or total bilirubin levels at least 1.5 times the upper limit of normal were excluded from clinical trials; therefore, this medicine should be administered with caution to these patients. Liver function tests should be performed before starting this medicine. 5. Patients who cannot swallow tablets For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as applesauce, and administered orally. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This medication is used to prevent or treat blood clots by inhibiting blood coagulation. However, it may cause bleeding during treatment, so careful monitoring for signs of bleeding is essential. If severe bleeding occurs, the use of this drug should be discontinued immediately. There is no need to regularly measure drug concentration using specific blood tests, but measuring concentration may be helpful in emergencies. This medication should not be used in certain patients, such as those who are allergic to this drug or its components, patients with severe bleeding, severe liver disease, or those at high risk for bleeding, patients with a history of recent gastrointestinal ulcers or intracranial hemorrhage, and those taking other anticoagulants. Patients with genetic issues such as lactose intolerance should also refrain from using this drug. Special caution is needed for patients with severe kidney disease or poor liver function, and those taking specific psychiatric medications or nonsteroidal anti-inflammatory drugs. Elderly patients or those with low body weight may also be at higher risk for bleeding. Patients undergoing spinal or epidural anesthesia require special attention as this drug may cause severe nerve damage. Common side effects include bleeding, bruising, nosebleeds, and hematomas. Rarely, severe bleeding, liver function abnormalities, and allergic reactions may occur, so it is vital to consult a healthcare professional if any unusual symptoms arise. This drug may interact with other medications, particularly specific antifungals, antivirals, anticoagulants, antiplatelet agents, and some analgesics. Patients must inform their healthcare provider about all medications they are currently taking before starting this drug. Use during pregnancy or breastfeeding is not recommended, and breastfeeding should be discontinued if this drug is administered. Safety in pediatric patients has not been established, so avoid use. Before surgery or invasive procedures, this drug should be discontinued for a certain period to reduce the risk of bleeding, and resumption should be based on the patient's condition and bleeding risk after the procedure. Overdosing this drug may increase the risk of bleeding, so it is essential to adhere to the prescribed dosage and consult a healthcare provider if any adverse reactions occur.

• Hemorrhage
• contusion
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic swelling
• anaphylactic reaction
• cerebral hemorrhage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is crucial to maintain storage temperatures between 1 degree and 30 degrees Celsius to preserve its effectiveness.

Appearance

Light yellow round film-coated tablets

Package unit

60 tablets/PTP (10 tablets/PTP*6)