Yuhan Apixaban Tablet 2.5 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 they remember 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 orally twice daily. The first dose should be administered 12 ~ 24 hours after surgery. The recommended duration of treatment is 32 ~ 38 days for patients who have undergone hip replacement surgery and 10 ~ 14 days for patients who have undergone knee replacement surgery. Reduction in 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 coadministration 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 undergo percutaneous coronary intervention. 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. Reduction in 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 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 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. As there is no clinical experience in patients on dialysis or in patients with creatinine clearance 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 administered with caution in these patients. Reduction in 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 in 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. 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, caution should be exercised when administering this medicine to such patients. Liver function tests should be performed before starting this medicine. For patients who cannot swallow tablets, immediately before use this medicine may be crushed, 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 clots by thinning the blood. Since bleeding may occur while taking this medication, any symptoms of bleeding should be reported to medical personnel immediately. This medication should not be used in patients at high risk of bleeding or those already experiencing bleeding. Patients with severely impaired kidney function or hepatic impairment should take this medication with caution, as some drugs can increase the risk of bleeding when used in combination. Particular caution is needed when used in conjunction with other medications that affect blood coagulation. Before undergoing surgery or invasive procedures, this medication should be temporarily discontinued, and after the procedure, it should only be resumed after considering the risk of bleeding. The safety of this medication during pregnancy or breastfeeding has not been established, so its use is not recommended. It is not used in children, as safety and efficacy have not been confirmed. Elderly patients may require special dosage adjustments, following medical guidance. In cases of overdose, the risk of bleeding significantly increases, so the dosage should be followed accurately, and if severe bleeding occurs, medical attention should be sought immediately. This medication may interact with certain drugs that inhibit or induce specific enzymes, so current medications must be disclosed to medical personnel. The effects on driving or operating machinery are limited, but caution should be exercised if bleeding or dizziness occurs. If any neurological symptoms (e.g., tingling in the legs, muscle weakness) appear while taking this medication, consult medical personnel immediately.

• Bleeding
• contusion
• epistaxis
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylactic reaction
• cerebral hemorrhage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Pale yellow round film-coated tablet

Package unit

60 tablets (10 tablets/PTP*6)