Eliquis Tablet 5mg (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 then 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 first 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 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 long term. There is limited experience with concomitant administration of the recommended dose of this medicine with antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who have acute coronary syndrome and/or have undergone percutaneous coronary intervention. 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, to be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching therapy When switching from parenteral anticoagulant therapy to this medicine, or from this medicine to a parenteral anticoagulant, the switch may be made at the time of the next scheduled dose. 1) Switching from vitamin K antagonist therapy to this medicine When switching from vitamin K antagonist therapy to this medicine, discontinue warfarin or another vitamin K antagonist and start this medicine when the International Normalized Ratio (INR) is below 2.0. 2) Switching from this medicine to vitamin K antagonist therapy When switching from this medicine to vitamin K antagonist therapy, continue 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 on dialysis or in patients with creatinine clearance below 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 have a body weight ≤ 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 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 exceeding 2 times the upper limit of normal or total bilirubin levels at or above 1.5 times 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 starting this medicine. 5. Patients unable to swallow tablets For patients unable to swallow tablets, this medicine may be crushed immediately before use and mixed with water or a beverage such as applesauce for oral administration. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This medication is an anticoagulant that helps prevent excessive blood clotting. However, bleeding may occur during treatment, so you must carefully observe for signs of bleeding. If severe bleeding occurs, discontinue the use of this medication immediately. This medication should not be administered to patients with certain medical conditions. For instance, it may be risky for patients who are allergic to this drug's components, currently have active bleeding, or have clotting issues due to liver disease. Additionally, patients who have recently undergone gastrointestinal ulcers, brain hemorrhage, spinal or brain surgery, or those with suspected esophageal varices, vascular abnormalities, or malignancies may face heightened risks of bleeding if they use this medication. It may also be risky to take this medication in combination with other anticoagulants; therefore, consult a doctor before concurrent use. Patients with severely impaired kidney function, weak liver function, and those with very low body weight should take this medication with caution as the drug concentration may increase, raising the risk of bleeding. Moreover, this medication may cause hematoma risk leading to nerve damage when administered to patients undergoing spinal or epidural anesthesia, so the timing around anesthesia should be adjusted, and neurological symptoms must be carefully monitored. For cancer patients, the risk of bleeding is also high, so risks and benefits should be thoroughly assessed before use. During treatment, common occurrences include bleeding, bruising, nosebleeds, and hematomas, while severe bleeding or allergic reactions may occur, so if any unusual symptoms arise, consult medical personnel immediately. This drug may increase the risk of bleeding when taken with other drugs that affect hemostasis, so extra caution is necessary when combined with antiplatelet drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors (SSRIs), etc. If undergoing surgery or invasive procedures, this medication should be discontinued at least 24-48 hours prior to reduce the risk of bleeding, and resuming should only occur after confirming bleeding risk and hemostatic status post-procedure. If pregnant or breastfeeding, use is not recommended as safety has not been established. If breastfeeding, the drug should be discontinued or breastfeeding should be stopped. Safety and efficacy for use in pediatric patients have not been confirmed, so it is advised not to use it in children. In case of overdose, there is a significantly increased risk of bleeding, so stop taking the drug immediately and seek medical treatment. There is no antidote for this medication, so proper treatment such as surgical hemostasis or plasma transfusion may be necessary in case of severe bleeding.

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

This medication must be stored in a tightly sealed container to protect it from exposure to air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

Pink, egg-shaped film-coated tablets with convex surfaces on both sides

Package unit

60 tablets/PTP (10 tablets/PTP×6)