Antithrombin Tablet 2.5 mg (Apixaban)

Adult dose

This medicine may 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. 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 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 in 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 an antiplatelet agent after hemostasis has been achieved in patients with nonvalvular atrial fibrillation accompanied by acute coronary syndrome and/or percutaneous coronary intervention. (Refer to ‘5. General precautions, 1) Interactions with other drugs that affect hemostasis’ under Precautions for Use and ‘12. Clinical Trial Information, 2) Reduction in 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 in the risk of recurrent 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 can 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, 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 Administration of this medicine is not recommended in patients receiving dialysis or with a creatinine clearance of 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 concentrations of this medicine increased in these patients; therefore, this medicine should be administered with caution in these patients. 2) Reduction in 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. 3) Treatment of deep vein thrombosis and pulmonary embolism/Reduction in the risk of recurrent 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 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 the normal range or total bilirubin levels at least 1.5 times the upper limit of the normal range 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 unable to swallow tablets For patients unable to swallow tablets, this medicine may be crushed and mixed with a liquid such as water or applesauce for oral administration immediately before use. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This drug is an anticoagulant that prevents blood from clotting too easily. Careful observation for bleeding is required during treatment, and if severe bleeding occurs, discontinue usage immediately. This medication does not require regular concentration monitoring through specific blood tests, but in emergencies, measuring blood concentration can be helpful. This medication should not be used in patients with allergies to any component, those with current severe bleeding, severe liver dysfunction, or diseases with a high risk of bleeding. Furthermore, it should not be used in patients taking other anticoagulants. Patients with specific genetic disorders, such as lactose intolerance, should also avoid this drug. Patients with severely impaired kidney or liver function, as well as those taking certain anti-inflammatory drugs or antidepressants, may have an increased risk of bleeding, so caution is advised. Particularly, elderly patients or those with low body weight may be at higher risk of bleeding. Patients undergoing spinal or brain surgery or procedures may be at risk of nerve damage while using this drug, hence dosage should be adjusted before and after procedures, and any neurological symptoms require immediate diagnosis and treatment. Various adverse reactions can occur with this medication, with the most common side effect being bleeding, including nosebleeds, bruises, and hematomas. Bleeding may occur in various areas such as the digestive tract, eyes, and brain, so if any bleeding symptoms occur, consult a doctor immediately. This drug may interact with other medications, especially when combined with antifungals, certain antibiotics, antivirals, anticoagulants, antiplatelet agents, and nonsteroidal anti-inflammatory drugs, increasing the risk of bleeding or altering efficacy. Pregnant or nursing women are advised against using this medication, and safety and efficacy have not been fully established in pediatrics. This drug does not have a significant impact on driving or operating machinery, but it should be discontinued for a certain period before surgery or invasive procedures, and the risk of thrombosis may increase upon discontinuation, so it should be resumed as soon as possible after stopping. In case of overdose, the risk of bleeding significantly increases, and immediately stopping the medication and undergoing appropriate treatment for controlling bleeding is necessary. This drug is effective for the prevention and treatment of thrombosis, but it is important to always be aware of bleeding risks and drug interactions while taking it.

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

This medication should be stored in a tightly closed container to prevent exposure to air and at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness and prevent deterioration.

Appearance

Light yellow round film-coated tablet

Package unit

30 tablets/bottle