Anguk Apixaban Tablet 2.5 mg

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 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 taken 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 the concomitant administration of the recommended dose of this medicine with an antiplatelet agent after hemostasis has been achieved in patients with nonvalvular atrial fibrillation with acute coronary syndrome and/or undergoing percutaneous coronary intervention. (Refer to ‘5. General precautions, 1) Interactions with other drugs affecting hemostasis’ under Precautions for Use and ‘12. Clinical Trial Information, 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, AUGUSTUS trial’.) 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 between medicines 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. 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 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. 3. Renal impairment As there is no clinical experience in patients receiving 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 blood concentrations of this medicine were increased in these patients; therefore, this medicine should be used 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 aged ≥ 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 concentrations of this medicine were increased in these patients; therefore, this medicine should be used with caution in these patients. 4. Hepatic impairment This medicine should not be used in 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. 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 the formation of clots by inhibiting excessive clotting of the blood. While taking this medication, patients should be closely monitored for signs of bleeding, as bleeding may occur. If bleeding becomes severe, the medication should be discontinued immediately and a doctor should be consulted. Patients with hypersensitivity to this medication, current active bleeding, or blood coagulation disorders should not take this medication. Furthermore, patients who have recently had gastrointestinal ulcers, cerebral hemorrhage, brain or spinal cord surgery, or certain conditions with a high risk of bleeding should also not use this medication. Patients with severely impaired kidney function or moderate to severe liver impairment should exercise particular caution when using this medication. Taking this medication alongside certain antidepressants, nonsteroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, or similar medications may increase the risk of bleeding, and consultation with a doctor is necessary. Patients undergoing spinal or epidural anesthesia are at risk of developing hematomas while on this medication, and they should be closely monitored for neurological symptoms. The administration of the medication should be adjusted before and after catheter removal. This medication is not recommended to be taken in conjunction with other anticoagulants, and patients with lactose intolerance should also avoid it. This medication is not recommended for pregnant women, and if breastfeeding, patients should consult their doctor regarding the use of the medication and nursing cessation. The safety and efficacy in children have not been established. No special dose adjustment is needed for the elderly, but caution should be exercised in those with low body weight or impaired kidney function. This medication may interact with other drugs, so inform healthcare professionals about all other medications being taken. It is essential to discontinue this medication for a certain period before undergoing surgery or invasive procedures and to resume after considering the risk of bleeding and need for treatment. In cases of overdose, the risk of bleeding increases, so strict adherence to the dosage is required, and if severe bleeding occurs, medical personnel should be notified immediately. This medication does not significantly affect driving or operating machinery, but caution should be exercised if symptoms such as bleeding or dizziness occur.

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

This medication may be sensitive to air and moisture and should be stored in a tightly sealed container. Additionally, it is important to store the medication at room temperature between 1 to 30 degrees Celsius for safe storage.

Appearance

Yellow round film-coated tablet

Package unit

60 tablets/box[(10 tablets/PTP X 6)]