Apixaban 5 mg Tablet (Apixaban)

Adult dose

This medicine may be taken with water, with or without food. If a patient misses a dose, they should take this medicine as soon as possible and then 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 given 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, 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. 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 given 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) is below 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, perform an INR test 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. There is no clinical experience in patients receiving dialysis or in patients with a creatinine clearance below 15 mL/min; therefore, 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 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 have a body weight ≤ 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 used with caution in these patients. This medicine must 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 exceeding 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 these patients. Liver function tests should be performed before starting this medicine. For patients who cannot swallow tablets, this medicine may be crushed immediately before use 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 helps reduce the occurrence of blood clots by preventing blood clotting. However, during the course of treatment, the risk of bleeding may increase, so any symptoms or signs of bleeding should be immediately reported to medical personnel. It is particularly unsafe to use this medication in patients with existing bleeding or blood coagulation disorders, severely impaired liver function, or recent brain or spinal surgery. Additionally, patients with gastrointestinal ulcers or a history of intracranial hemorrhage should avoid using this medication. The risk of bleeding may be further increased when taken with other anticoagulants, so caution is advised during combination therapy. Patients with severely impaired kidney or liver function, the elderly, and those with very low body weight should exercise extra caution when using this drug, and dosage adjustment may be necessary. Patients receiving spinal or epidural anesthesia require special monitoring by medical personnel due to the risk of nerve damage associated with this medication. This drug may interact with various medications, so anyone taking other medications should inform their doctor or pharmacist. Pregnant or nursing women are not recommended to take this drug; thorough consultation with a specialist is required before use. Safety in children has not been established, so it is best not to use this drug in pediatric patients. In case of overdose, the risk of bleeding significantly increases, so the dosage must be adhered to precisely, and immediate medical treatment should be sought for severe bleeding symptoms. Finally, prior to undergoing surgery or invasive procedures, this medication should be discontinued for a certain period, and after the procedure, the risk of bleeding and the necessity for treatment should be carefully assessed before resuming use.

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

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is safest to keep it at room temperature between 1 to 30 degrees Celsius. Maintaining appropriate temperature and container conditions can effectively preserve the medication's efficacy.

Appearance

Pink egg-shaped, convex film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP)], 60 tablets/box [(10 tablets/PTP×6)]