Apixol Tablet 5mg (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 continue taking it twice daily as before. 1. Adults 1) 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 first dose should be administered 12 ~ 24 hours after surgery. The recommended duration of treatment in patients who have undergone hip replacement surgery is 32 ~ 38 days. The recommended duration of treatment in patients who have undergone knee replacement surgery is 10 ~ 14 days. 2) 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 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. (See “5. General precautions, 1) Interactions with other drugs that affect hemostasis” and “12. Clinical trial information, 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, AUGUSTUS trial” under Precautions for Use.) 3) 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. 4) 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. 2. Switching between drugs When switching from parenteral anticoagulant therapy to this medicine or from this medicine to a parenteral anticoagulant, the switch can be made with the next scheduled dose. 1) 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) is less than 2.0. 2) Switching from this medicine to vitamin K antagonist therapy To switch 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 the 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 greater. 3. Renal impairment Administration of this medicine is not recommended in patients on dialysis or in patients with creatinine clearance less than 15 mL/min, as there is no clinical experience in these patients. 1) 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 levels of this medicine are increased in these patients; therefore, this medicine should be administered with caution in these patients. 2) 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 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. 3) 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 levels of this medicine are increased in these patients; therefore, this medicine should be administered with caution in these patients. 4. Hepatic impairment 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 such patients. Liver function tests should be performed before starting this medicine. 5. Patients who cannot swallow tablets 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 preventing blood from clotting. However, bleeding may occur during treatment, so signs of bleeding should be closely monitored. If severe bleeding occurs, the use of this medication should be stopped immediately. This medication should not be used in certain patients, such as those with active bleeding, bleeding disorders, severe liver disease, a history of intracranial hemorrhage or gastrointestinal ulcers, etc. Additionally, the risk of bleeding may significantly increase when used with other anticoagulants, so co-administration should be avoided. Patients with severely reduced kidney function, impaired liver function, the elderly, and those with low body weight should be particularly cautious when using this medication. Patients undergoing procedures like central nervous system anesthesia or spinal taps are at risk of serious neurological damage due to this medication, so they should consult with healthcare providers. Cancer patients or those at high risk of thrombosis should also consult with their doctor before using this medication. During treatment, symptoms related to bleeding, such as bleeding, nosebleeds, bruising, hematuria, etc., may frequently occur; if any of these symptoms appear, they should be reported to healthcare providers immediately. If surgical or invasive procedures are planned, it is advisable to stop taking this medication at least 24-48 hours prior, and to restart it as soon as possible after hemostasis is stabilized post-surgery. This medication may interact with other drugs, particularly antifungals, antivirals, anticoagulants, antiplatelet agents, and some painkillers or antidepressants, so be sure to inform your doctor or pharmacist if you are taking these. The safety of this medication has not been established during pregnancy or breastfeeding, so it is advisable not to use it. Safety in children has also not been adequately verified. Driving or operating machinery is generally safe while taking this medication, but caution should be exercised if symptoms of bleeding or dizziness occur. Overdose significantly increases the risk of bleeding, so it is essential to adhere to the prescribed dosage and regimen. If overdose is suspected, seek medical attention immediately.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is best to maintain room temperature between 1 degree and 30 degrees Celsius to preserve the medication's efficacy.

Appearance

Pink, oval, convex film-coated tablets

Package unit

60 tablets/PTP [(10 tablets/PTP x 6)]