Apixaban 2.5 mg Tablet

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) 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 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. 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 medications When switching from a parenteral anticoagulant to this medicine or from this medicine to a parenteral anticoagulant, the switch may be made starting 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 this medicine for 2 days after starting the vitamin K antagonist. After 2 days of combined treatment with this medicine and a vitamin K antagonist, measure the INR immediately before the scheduled dose of this medicine and continue combined 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 blood concentrations of this medicine were 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 aged ≥ 80 years or weighing ≤ 60kg with serum creatinine ≥1.5 mg/dL (133 micromole/L) 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 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 levels more than 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, this medicine should be administered with caution 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 thrombosis by inhibiting blood coagulation. While taking this medication, it is important to carefully monitor for signs of bleeding, as bleeding may occur. If serious bleeding occurs, this medication should be stopped immediately. This medication should not be used in certain patients, such as those with a high risk of bleeding or coagulation disorders. Additionally, patients with a history of allergy to this medication or certain liver diseases, gastrointestinal ulcers, or intracranial hemorrhage should not receive it. The risk of bleeding may significantly increase if this medication is used in conjunction with other anticoagulants, so co-administration should be avoided. This medication should be used with caution in patients with severely impaired kidney function or liver function. When taking this medication with some antidepressants, anti-inflammatory drugs, and aspirin, there is an increased risk of bleeding, so caution is needed. Particularly, older adults or patients with low body weight may have a higher risk of bleeding, thus careful administration is required. Patients receiving spinal or epidural anesthesia should take special precautions, as this medication may pose a risk of nerve damage. In cancer patients, the risks of bleeding and thrombosis should be carefully evaluated when using this medication. Common side effects of this medication include bleeding, bruising, nosebleeds, and hematomas; in serious cases, intracranial hemorrhage or gastrointestinal bleeding may occur. If undergoing surgery or invasive procedures, this medication should be discontinued for a certain period due to the risk of bleeding, and it should be resumed once the condition stabilizes post-procedure. Abruptly stopping this medication may increase the risk of thrombosis, so patients should not discontinue it on their own and should consult with a doctor. Pregnant or breastfeeding women are advised not to take this medication, and breastfeeding should be discontinued if this medication is taken. The safety and efficacy of this medication have not been established in children. This medication may interact with other drugs, so if patients are taking other medications, they must inform their doctor or pharmacist. In the case of overdose, the risk of bleeding significantly increases, so immediate contact with a medical institution is required for appropriate treatment. This medication does not significantly impact driving or machine operation, but caution is necessary as side effects such as bleeding may occur.

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

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The recommended storage temperature is between 1 and 30 degrees Celsius (room temperature).

Appearance

Pale yellow round film-coated tablet

Package unit

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