Apixaban 2.5 mg Tablets (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 possible and continue taking it twice daily as before. 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 is 32 ~ 38 days for patients who have undergone hip replacement surgery. The recommended duration of treatment is 10 ~ 14 days for patients who have undergone knee replacement surgery. 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. Treatment of acute deep vein thrombosis and pulmonary embolism: The recommended dose of this medicine is 10mg taken orally twice daily for 7 days, followed by 5mg taken orally twice daily. 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 it should be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. When switching from parenteral anticoagulant therapy to this medicine or from this medicine to parenteral anticoagulant therapy, the switch can be made at the time of the next scheduled dose. 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, International Normalized Ratio) is less than 2.0. When switching 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 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. 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. 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 used with caution in these patients. 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. 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 used with caution in these patients. 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 used 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 used with caution in these patients. Liver function tests should be performed before starting treatment with this medicine. 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 thin the blood to prevent or treat thrombosis. Signs of bleeding should be closely monitored during treatment, and special caution is necessary if there is a high risk of bleeding. If serious bleeding occurs, the use of this medication should be stopped immediately. This medication should not be administered to patients with specific blood coagulation disorders or high bleeding risks. It should be used cautiously in patients with severely impaired liver or kidney function and when taken with other bleeding risk medications. Especially in elderly patients or those with low body weight, there may be a higher risk of bleeding. Patients receiving spinal or epidural anesthesia should be closely monitored for neurological symptoms as there is a risk of hematoma formation during treatment. This medication should not be combined with other anticoagulants, and any medications being taken must be disclosed due to potential interactions. Use in pregnant or breastfeeding women is not recommended. Safety in children has not been established. Moreover, if planning surgery or invasive procedures while taking this medication, it is necessary to discontinue use for a certain period and consider the bleeding risk. In case of overdose, the risk of bleeding increases, and immediate consultation with medical staff is essential, as there is no antidote for this medication and appropriate treatment is needed if serious bleeding occurs. This medication does not significantly impact driving or operating machinery, but caution is necessary if bleeding symptoms arise. Common adverse reactions during use include bleeding, bruising, nosebleeds, etc., and should serious bleeding symptoms occur, medical attention should be sought immediately.

• Hemorrhage
• contusion
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylactic reaction
• cerebral 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 storage temperatures between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness and safety of the medication for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

60 tablets/box [(10 tablets/PTP * 6)]