Apixaban Tablet 2.5 mg (Apixaban)

Adult dosage

Take 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 undergoing hip or knee replacement surgery: The recommended dose is 2.5 mg orally twice daily. The initial dose is administered 12 ~ 24 hours after surgery. The recommended duration of treatment in patients undergoing hip replacement surgery is 32 ~ 38 days. The recommended duration of treatment in patients undergoing knee replacement surgery is 10 ~ 14 days. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose is 5 mg orally twice daily. However, in patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics, the recommended dose is 2.5 mg 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 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 of the risk of recurrence of deep vein thrombosis and pulmonary embolism: The recommended dose is 2.5mg orally twice daily, 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 the other 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 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 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 greater. As there is no clinical experience in patients receiving dialysis or in patients with a creatinine clearance below 15 mL/min, use of this medicine is not recommended. Prevention of venous thromboembolism in adult patients undergoing 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 age ≥ 80 years or have a body weight ≤ 60kg should receive this medicine at a dose of 2.5 mg twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive this medicine at a dose of 2.5 mg 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 1.5 times or more 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 unable to swallow tablets, this medicine may be crushed immediately before use, mixed with water or a drink 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 thrombus formation by inhibiting excessive blood clotting. During the use of this medication, bleeding symptoms may appear, and it is crucial to closely monitor for signs of bleeding. In case of severe bleeding, the use of this medication must be stopped immediately and medical consultation should be sought. This medication should not be administered to patients at high risk of bleeding or those with bleeding disorders. Careful use of this medication is required in patients with severely impaired renal or liver function, and medical staff may adjust the dosage if necessary. The risk of bleeding may increase when this medication is used in combination with other anticoagulants or drugs affecting blood coagulation, so it is essential to inform healthcare providers of any other medications being taken. Before undergoing surgery or invasive procedures, this medication should be discontinued for a certain period, and the timing for resuming administration should be determined considering the risk of bleeding post-procedure. Use of this medication is not recommended during pregnancy or breastfeeding, and medical consultation is necessary before use. Elderly or underweight patients may have an increased risk of bleeding and thus require caution. Overdose of this medication may significantly increase the risk of bleeding, so it is essential to adhere to the prescribed dosage, and if an overdose is suspected, immediate consultation with medical staff is required. This medication does not significantly affect driving or machinery operation; however, caution should be exercised in the presence of symptoms such as bleeding or dizziness. While regular blood tests to assess bleeding risk are not required during the course of this medication, measuring drug concentration in blood may be helpful in emergency situations. There may be drugs that can interact with this medication, so it is vital to discuss with healthcare providers before starting any new medications.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to maintain ambient storage temperatures between 1 and 30 degrees Celsius. Storing it this way will help retain the drug's effectiveness for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

60 tablets/box [(10 tablets/PTP)×6]