Myungin Apixaban Tablet 2.5 mg

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 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 taken between 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, the recommended dose for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics 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 and 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 in 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 orally twice daily for 7 days, followed by 5mg orally twice daily. 4) Reduction in 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 completing 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 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 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 just 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, administration 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 for 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 are 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 for 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 this medicine at a dose of 2.5 mg twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive this medicine at a dose of 2.5 mg twice daily, regardless of age or body weight. 3) Treatment of deep vein thrombosis and pulmonary embolism/ Reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism No dose adjustment is necessary for 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 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 for 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 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 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 liquid 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 thrombus formation by inhibiting blood clotting. During treatment with this medication, bleeding may occur, so signs of bleeding such as nosebleeds, gum bleeding, hematuria, and black stools should be closely monitored. If severe bleeding occurs, stop taking this medication immediately and consult a healthcare professional. This drug should not be used in patients with certain blood coagulation disorders, active bleeding, or severe liver dysfunction. Patients with a recent history of gastrointestinal ulcer, intracranial hemorrhage, or surgery on the brain or spinal cord should also avoid using this medication. Taking this drug concurrently with other anticoagulants may increase the risk of bleeding, so caution is required during co-administration. Patients who are genetically intolerant to lactose should not take this medication. Patients with severely compromised renal function or mildly impaired liver function should use this medication with caution, as the risk of bleeding may increase when taken with certain antidepressants or non-steroidal anti-inflammatory drugs. Elderly patients or those weighing less than 60 kg are also at higher risk of bleeding and should be cautious. Patients receiving spinal or epidural anesthesia are at risk of developing hematomas due to this medication, so neurological symptoms should be monitored closely during administration. Interactions with other drugs used together may occur; therefore, inform your healthcare provider about any medications being taken. Use during pregnancy or breastfeeding is not recommended, particularly during breastfeeding, where discontinuation of medication or breastfeeding may be necessary. The safety and efficacy in pediatric patients have not been established. If surgery or invasive procedures are planned while taking this drug, it may be necessary to stop medication for a certain period to reduce the risk of bleeding. In case of overdose, the risk of bleeding may increase significantly, so it’s important to adhere strictly to the dosage recommendations, and if an overdose is suspected, consult a healthcare professional immediately. This medication does not significantly impact driving or machine operation, but caution is necessary if there are symptoms of bleeding or dizziness.

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

This medication may be sensitive to air or humidity, so it should be stored in a tightly closed container. The ideal storage temperature is between 1 to 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

60 tablets (10 tablets/PTP x 6)