Apixabane 2.5 mg Tablets

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 undergoing hip or knee replacement surgery: The recommended dose is 2.5 mg of this medicine orally twice daily. The initial dose should be taken between 12 ~ 24 hours after surgery. The recommended duration of treatment is 32 ~ 38 days in patients undergoing hip replacement surgery. The recommended duration of treatment is 10 ~ 14 days in patients undergoing 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 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 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 of the risk of recurrent deep vein thrombosis and pulmonary embolism: The recommended dose is 2.5mg of this medicine orally twice daily, to 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 a parenteral anticoagulant, 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, administration 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. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the blood concentration of this medicine increased in these patient groups; 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: 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 of the risk of recurrent deep vein thrombosis and pulmonary embolism: No dose adjustment is necessary 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 increased in these patient groups; 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. 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, 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, 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. During treatment with this medication, there is a risk of bleeding, so signs of bleeding should be closely monitored. If severe bleeding occurs, stop taking this medication immediately and consult a healthcare provider. Routine blood concentration measurement is not necessary with specific coagulation tests; however, confirming blood levels may be helpful in emergencies. This medication should not be taken by individuals with known allergies to it, those with active bleeding, or those with diseases that have a high risk of bleeding. Patients with severely decreased liver or kidney function, recent history of intracranial hemorrhage or gastrointestinal ulcers, vascular abnormalities, or recent surgeries on the brain or spinal cord should use this medication cautiously. Combining this medication with other anticoagulants increases the risk of bleeding and should be avoided; transitioning from this medication to another anticoagulant should be done under healthcare supervision. Patients with genetic issues such as lactose intolerance should not take this medication. There is an increased risk of bleeding when this medication is taken with nonsteroidal anti-inflammatory drugs such as acetylsalicylic acid, so caution is warranted. Older adults or those with low body weight may have a higher risk of bleeding. Patients undergoing spinal or epidural anesthesia while on this medication face a risk of hematoma, so they should consult their healthcare providers for appropriate actions. To reduce the risk of bleeding, this medication should be discontinued for a certain period before any surgeries or invasive procedures and should be resumed afterward based on the situation. Pregnant or breastfeeding women are advised not to take this medication, as they may need to halt either breastfeeding or taking the medication during this time. The safety and efficacy of this medication in children have not been established. This medication can interact with multiple drugs, so it is essential to inform healthcare providers of any other medications being taken. Overdosage increases the risk of bleeding, so it is crucial to adhere to the prescribed dosages, and if bleeding symptoms occur, immediate consultation with healthcare providers is necessary. It does not significantly affect driving or machinery operations, but caution is needed if symptoms like bleeding or dizziness occur.

• Hemorrhage
• contusion
• epistaxis
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylactic reaction
• intracerebral hemorrhage

This medication may be sensitive to air and moisture, so it must be stored in a tightly closed container. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

10 tablets (10 tablets/PTP), 60 tablets (10 tablets/PTP x 6)