Apixaban Tablets 5 mg (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 immediately and then 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 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. 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 coadministration of the recommended dose of this medicine with an antiplatelet agent after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who have acute coronary syndrome and/or have undergone percutaneous coronary intervention. (Refer to ‘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, and it should be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching medications When switching from parenteral anticoagulant therapy to this medicine or from this medicine to a parenteral anticoagulant, the switch may be made at the time of the next scheduled dose. 1) Switching from vitamin K antagonist therapy to this medicine When switching from vitamin K antagonist therapy to this medicine, discontinue warfarin or other vitamin K antagonist therapy 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 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, check 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. 3. Renal impairment As there is no clinical experience in patients on dialysis or in patients with creatinine clearance less than 15 mL/min, use of this medicine is not recommended. 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 the blood concentration of this medicine was 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 take 2.5 mg of this medicine twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should take 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 the blood concentration of this medicine was 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. 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 ≥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. 5. Patients unable to swallow tablets For patients unable to 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 acts to prevent blood from clotting. While taking this medication, patients should closely observe for signs of bleeding as it can occur. If severe bleeding occurs, discontinue the use of this medication immediately. This medication is not to be used in patients with a significantly high risk of bleeding, such as those with active bleeding, severely impaired liver function, or a history of recent intracranial hemorrhage or gastrointestinal ulcers. Patients allergic to lactose contained in this medication should not take it. Caution is advised for patients with severely impaired kidney function or slightly impaired liver function, and for those taking certain antidepressants or nonsteroidal anti-inflammatory drugs, as the risk of bleeding may increase. Elderly patients or those with low body weight should also be cautious, as the risk of bleeding may be elevated. Patients undergoing surgery or procedures related to the spinal cord or brain should be particularly careful due to the risk of nerve injury while taking this medication. Additionally, it is generally recommended not to take this medication concurrently with other anticoagulants, and conversion should be done under the guidance of a specialist when necessary. If this medication is taken with certain antifungals or antivirals, or some antibiotics, the concentration of the drug may change, so consultation with healthcare providers is necessary. It is not recommended for pregnant or breastfeeding women to take this medication, and especially during breastfeeding, it is safer to discontinue breastfeeding while on this medication. Safety in children has not been established, so it is not to be used in pediatric patients. This medication may cause side effects such as bleeding, nosebleeds, bruising, hematuria, so any occurrence of these symptoms should be reported to medical personnel immediately. If a surgical or invasive procedure is planned, this medication should be discontinued at least 24 to 48 hours prior, and its use should be resumed only after the risk of bleeding has decreased post-procedure. In cases of overdose, the risk of bleeding significantly increases, necessitating caution, and special treatment may be required in emergencies. This medication does not significantly impact driving or operating machinery; however, caution should be exercised if symptoms of bleeding or dizziness occur.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature to preserve the drug's efficacy and safety.

Appearance

Pink, oval, convex film-coated tablets

Package unit

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