Elihigh Tablet 2.5 mg (Apixaban)

Adult dose

This medicine may be taken with water, with or without food. If a patient forgets to take a dose, they should take this medicine as soon as they remember and continue taking it twice daily as before. 1. Adults 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 first 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 taken 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 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 the concomitant use of the recommended dose of this medicine with antiplatelet agents 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 taken orally twice daily for 7 days, followed by 5mg taken orally twice daily. 4) Reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism The recommended dose is 2.5mg of this medicine taken orally twice daily, after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching medications When switching from parenteral anticoagulant therapy to this medicine or from this medicine to a parenteral anticoagulant, the switch may be made with 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 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 therapy To switch from this medicine to vitamin K antagonist therapy, continue taking 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 immediately 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 As there is no clinical experience in patients receiving dialysis or in patients with a creatinine clearance of less than 15 mL/min, use of this medicine is not recommended. 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 are 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 recurrent 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 are 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 more than 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, caution should be exercised when administering this medicine to such patients. Liver function tests should be performed before starting treatment with 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 prevents blood clotting and is used to prevent or treat thrombosis. During treatment, bleeding may occur, so signs of bleeding should be closely monitored. If severe bleeding occurs, the use of this medication must be stopped immediately, and appropriate treatment should be sought if necessary. This medication should not be used in patients with certain blood coagulation disorders or active bleeding. Additionally, patients with severely impaired liver function or a recent history of intracerebral hemorrhage or gastrointestinal ulcers may be at increased risk of bleeding when taking this medication, so caution is advised. When used in conjunction with other anticoagulants, there may be a significantly increased risk of bleeding; therefore, concurrent use should be avoided. Patients with lactose intolerance or certain genetic metabolic disorders should also avoid this medication. Patients with severely impaired kidney function or mildly impaired liver function should use this medication with special caution. Furthermore, co-administration with certain antidepressants or non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of bleeding, so caution is necessary. Elderly patients or those with low body weight are also at an increased risk of bleeding and should be managed carefully. Patients undergoing spinal or epidural anesthesia are at risk of developing hematomas and nerve damage, and therefore should consult with their healthcare provider before using this medication. Cancer patients are also at a heightened risk of bleeding, so the risks and benefits should be evaluated carefully when using this medication. This medication can interact with multiple drugs, so patients should inform their healthcare provider of any other medications they are taking. Special caution is required when used in conjunction with drugs that inhibit or activate enzymes that metabolize drugs in the liver. Pregnant or nursing women should preferably avoid this medication, and nursing mothers should discuss the use of this medication with their healthcare provider. The safety of this medication in children has not been sufficiently established, so it is not to be used in children. Before surgery or invasive procedures, this medication should be discontinued for a specified duration, and after the procedure, it can be resumed considering the risk of bleeding and patient's condition. In case of overdose, the risk of bleeding significantly increases, and immediate medical attention should be sought for appropriate treatment. This medication does not significantly affect driving or operating machinery; however, caution is advised due to the potential for symptoms such as bleeding or dizziness.

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

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. Additionally, it is best to store the medication at room temperature between 1°C and 30°C, avoiding places that are excessively hot or cold.

Appearance

Yellow round film-coated tablet

Package unit

60 tablets/PTP [10 tablets/PTPX6]