Aqius Tablet 5 mg (Apixaban)

Adult dose

This medicine should be taken with water, with or without food. If a patient misses 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 orally twice daily. The initial dose is 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. 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, patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics should receive the recommended dose of 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 the concomitant use of the recommended dose of this medicine and antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation accompanied by acute coronary syndrome and/or 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 treatment should be initiated after completion of at least 6 months of treatment with this medicine or another anticoagulant. When switching from parenteral anticoagulants to this medicine or from this medicine to parenteral anticoagulants, 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 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 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 required 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 in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: No dose adjustment is required 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 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 required 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 used in patients with liver disease associated with coagulopathy and a clinically significant risk of bleeding. No dose adjustment is required 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 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 treatment with this medicine. For patients who cannot swallow tablets, immediately before use, this medicine may be crushed 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 used to prevent or treat the formation of blood clots by inhibiting blood clotting. While taking this medication, the risk of bleeding may increase, so careful observation for signs of bleeding is necessary. If severe bleeding occurs, this medication must be discontinued immediately. It should not be administered to patients with a high risk of bleeding or blood coagulation disorders. Use with caution in patients with severely impaired kidney or liver function, as the risk of bleeding may increase when taken with certain medications. Particular caution is required when used in combination with antiplatelet agents or non-steroidal anti-inflammatory drugs. Before undergoing surgery or invasive procedures, this medication should be discontinued for a period of time, and resumption should consider the risk of bleeding and hemostatic status after the procedure. It is advisable to avoid the use of this medication during pregnancy or breastfeeding, and safety in pediatric patients has not been established. Elderly or underweight patients may have a higher risk of bleeding and should be monitored closely. In cases of overdose, the risk of bleeding increases significantly; immediate consultation with medical personnel is necessary, as there is no antidote for this medication, requiring appropriate treatment in case of bleeding. During the course of treatment, frequent monitoring for bleeding symptoms or neurological abnormalities is necessary, and medical personnel should be informed immediately if any abnormal symptoms arise.

• Bleeding
• bruise
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylaxis
• intracerebral hemorrhage

This medication should be stored in a tightly closed container to prevent air or moisture from entering. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius.

Appearance

Pink, oval-shaped, film-coated tablet with a convex surface on both sides.

Package unit

60 tablets - 10 tablets/PTP [x6]