Elsaban Tablet 5 mg (Apixaban)

Adult dose

This medicine should be taken with water, with or without food. If a patient forgets to take 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 orally twice daily. The initial dose should be administered 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 orally twice daily. However, for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics, the recommended dose is 2.5 mg of this medicine orally twice daily; age≥80 years, body weight ≤60kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L). Treatment should be continued for a long term. There is limited experience with coadministration of the recommended dose of this medicine and 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 orally twice daily, and it should be administered after completing at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between medications When switching from parenteral anticoagulant therapy 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 therapy to this medicine To switch from vitamin K antagonist therapy to this medicine, discontinue warfarin or another vitamin K antagonist and initiate this medicine when the International Normalized Ratio (INR) is less than 2.0. 2) Switching from this medicine to vitamin K antagonist therapy To switch from this medicine to vitamin K antagonist therapy, continue administering this medicine for 2 days after starting the vitamin K antagonist. After 2 days of concomitant treatment with this medicine and a 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 Administration of this medicine is not recommended in patients receiving dialysis or in patients with a creatinine clearance of less than 15 mL/min, as 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 were 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 age ≥ 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 were 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. Administration 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 of 1.5 times or more the upper limit of normal were excluded from clinical trials; therefore, caution should be exercised when administering this medicine to these patients. Liver function tests should be performed before initiating this medicine. 5. Patients unable to swallow tablets For patients unable to 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 medicine is used to prevent or treat thrombus by inhibiting blood coagulation. Careful observation for bleeding symptoms is required during medication since bleeding can occur. It should be used cautiously in states of high bleeding risk, similar to other anticoagulants. If severe bleeding occurs, this medication should be stopped immediately, and medical consultation is necessary. This medication does not require regular blood concentration monitoring through specific blood tests; however, testing may be helpful in case of overdose or emergency. This medication should not be administered to patients with allergies to its components, current serious bleeding conditions, severely impaired liver function, or patients who have recently had gastrointestinal ulcers, brain hemorrhage, or surgery of the brain or spinal cord, as these patients are at high risk for bleeding. Additionally, caution is required when taken concurrently with other anticoagulants, and patients with genetic issues like lactose intolerance should not use this medication. Patients with severely impaired kidney function or slightly impaired liver function require special attention when using this drug. Furthermore, combining this medication with serotonin reuptake inhibitors or non-steroidal anti-inflammatory drugs can increase the bleeding risk, so caution is necessary. Elderly patients or those with low body weight also have a higher risk of bleeding and should be monitored carefully. Patients receiving spinal or epidural anesthesia are at risk for hematoma formation; therefore, appropriate measures must be taken before and after taking this medication. The safety and efficacy of this drug have not been established in certain patients such as those with pulmonary embolism or cancer; thus, caution is warranted. This medication can commonly lead to adverse reactions including bleeding, bruising, nosebleeds, hematomas, nausea, thrombocytopenia, hypersensitivity, allergic edema, ocular bleeding (including conjunctival bleeding), hypotension, gastrointestinal bleeding, hemorrhoidal bleeding, oral bleeding, rectal bleeding, gingival bleeding, retroperitoneal bleeding, increased transaminases, increased aspartate aminotransferase, increased gamma-glutamyltransferase, liver function test abnormalities, and increased blood alkaline phosphatase. Caution should be exercised when taking this drug with other medications that can heighten the risk of bleeding. In particular, interactions may occur with antiplatelet agents, specific antibiotics, antifungals, and antivirals, so it is essential to inform about all medications being taken. This medication should be discontinued for a certain period before surgery or invasive procedures, and its administration should be resumed post-procedure depending on the situation. It is not recommended for pregnant women, and breastfeeding mothers may have to discontinue breastfeeding or stop taking the medication due to the possibility of excretion in breast milk. Safety and efficacy have not been established in children. While this drug does not significantly affect driving or machine operation, caution is necessary if bleeding or similar symptoms occur. In case of overdose, the risk of bleeding increases, and the medication should be stopped immediately, followed by consultation with a healthcare professional. There is no specific antidote, so appropriate medical treatment is necessary if severe bleeding occurs.

• Bleeding
• contusion
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylaxis
• cerebral hemorrhage

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the efficacy and safety of the medication for a longer period.

Appearance

Pink egg-shaped film-coated tablets that are convex on both sides

Package unit

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