Apixaban 2.5 mg Tablet (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. 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 administration 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 other vitamin K antagonist therapy 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 combined treatment with this medicine and a vitamin K antagonist, measure the INR immediately before the scheduled dose of this medicine, and continue combined 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 take 2.5 mg of this medicine twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should take 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 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 greater 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, this medicine should be administered with caution to these patients. Liver function tests should be performed before starting treatment with this medicine. 5. 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 clot formation by inhibiting blood coagulation. During the use of this medication, bleeding may occur, so signs of bleeding should be carefully monitored. If severe bleeding occurs, the use of this medication should be discontinued immediately. This drug should not be used in patients with known allergies to it, currently experiencing severe bleeding, severe liver impairment, or recent history of gastrointestinal ulcers or intracranial hemorrhage, as these patients are at high risk for bleeding. Additionally, when taken in combination with other anticoagulants, the risk of bleeding may increase significantly, so co-administration should be avoided. Patients with severe renal impairment or slight liver impairment, elderly patients, and underweight patients should use this medication with caution. In particular, patients undergoing spinal or epidural anesthesia are at risk of serious nerve damage due to bleeding and should use this drug carefully. Side effects such as bleeding, bruising, nosebleeds, and hematoma are common, while severe bleeding, liver dysfunction, and allergic reactions may occur rarely. Interactions with other drugs should also be considered, especially if drugs that inhibit or induce metabolizing enzymes in the liver are taken concurrently, as the effects of this drug may change. The safety of this medication in pregnant and breastfeeding women has not been established, so its use is not recommended, and safety has also not been confirmed in children. If surgery or invasive procedures are planned, it may be necessary to stop this medication for a period of time before the procedure to reduce the risk of bleeding. In case of overdose, the risk of bleeding increases significantly, so immediate consultation with medical personnel is necessary, and since no specific antidote exists, treatment may be needed to control bleeding.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the drug's effectiveness.

Appearance

Yellow round film-coated tablet

Package unit

10 tablets/PTP, 60 tablets/PTP [(10 tablets/PTP) X 6]