Apixaban 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 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 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, and 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. There is limited experience with the concomitant administration 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 have undergone 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 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, 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. Switching from vitamin K antagonist therapy to this medicine: To switch 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. Switching from this medicine to vitamin K antagonist therapy: To switch 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 higher. As there is no clinical experience in patients on dialysis or in patients with creatinine clearance less than 15 mL/min, administration of this medicine is not recommended. Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery (renal impairment): No dose adjustment is required in patients with mild or moderate renal impairment. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the blood concentration of this medicine was increased in these patients; therefore, this medicine should be administered with caution in these patients. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (renal impairment): No dose adjustment is required in patients with mild or moderate renal impairment. However, patients aged ≥ 80 years or weighing ≤ 60kg with serum creatinine ≥1.5 mg/dL (133 micromole/L) 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 (renal impairment): No dose adjustment is required in patients with mild or moderate renal impairment. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the blood concentration of this medicine was 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 required in patients with mild or moderate hepatic impairment (Child Pugh A or B), but this medicine should be administered with caution. Administration 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, this medicine should be administered with caution to 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 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 blood clots by inhibiting blood coagulation. However, during the use of this medication, bleeding may occur, so signs of bleeding should be closely monitored. In cases of severe bleeding, the use of this medication should be discontinued immediately, and appropriate treatment should be sought as per the physician's instructions. This medication should not be administered to patients with certain disorders or conditions. For example, patients with a high risk of bleeding or coagulation disorders, patients with a recent history of intracranial hemorrhage or gastrointestinal ulcers, certain liver disease patients, and patients with genetic issues such as lactose intolerance should not take this medication. Additionally, the combination of this medication with other anticoagulants can be dangerous, so if combination therapy is needed, consult a physician. Particularly, concurrent use with unfractionated heparin or other oral anticoagulants is not recommended. This medication should be used cautiously in patients with significantly impaired kidney or liver function, elderly patients, those with very low body weight, and patients undergoing spinal or epidural anesthesia. Such patients may be at a higher risk of bleeding, requiring special attention. During the use of this medication, abnormal symptoms such as bleeding, bruising, nosebleeds, hematuria, etc., may appear, and if these symptoms occur, immediate consultation with a physician is advised. Furthermore, this medication can interact with various other drugs, so if other medications are being taken, it is essential to inform a physician or pharmacist for proper management. In particular, the risk of bleeding may increase when combined with antifungal agents, antiviral agents, certain antibiotics, antidepressants, and anti-inflammatory analgesics. Pregnant or breastfeeding women are advised not to take this medication, and a consultation with healthcare personnel is obligatory when considering its use. If a surgical or invasive procedure is planned, this medication should be discontinued for a certain period beforehand to reduce the risk of bleeding, and after the procedure, it should be resumed only after ensuring hemostatic conditions are stable. In cases of overdose, the risk of bleeding may significantly increase, so adherence to the prescribed dosage is crucial, and if overdose is suspected, immediate medical attention should be sought. Finally, the safety and efficacy of this medication in children have not been adequately confirmed, so it is advisable not to administer this drug to pediatric patients.

• bleeding
• bruising
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylaxis reaction
• cerebral hemorrhage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain storage at room temperature between 1 to 30 degrees Celsius. This helps preserve the effectiveness and safety of the medication for an extended period.

Appearance

Pink, oval, film-coated tablets with convex sides

Package unit

60 tablets/box [10 tablets/PTP×6]