Apixaban Tablet 2.5 mg (Apixaban)

Adult dose

This medicine should be taken with water, with or without food. If a patient misses 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 orally twice daily. The initial 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 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 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 orally twice daily for 7 days, followed by 5mg orally twice daily. 4) Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended dose is 2.5mg orally twice daily, to 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 change 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 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 required in patients with mild or moderate renal impairment. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), 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 required 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 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 of the risk of recurrence of deep vein thrombosis and pulmonary embolism No dose adjustment is required in patients with mild or moderate renal impairment. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), 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 required 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 greater than 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. For patients who cannot 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 medication prevents blood from coagulating and thus prevents the formation of clots. During treatment with this drug, bleeding may occur, so it is essential to monitor carefully for symptoms of bleeding such as nosebleeds, bruising, or bleeding at wound sites. If severe bleeding occurs, it is necessary to stop taking this medication immediately and consult a healthcare professional. Routine blood tests to monitor blood levels are not required with this medication; however, in cases of overdose or emergency surgical situations, checking blood levels may be helpful. This drug should not be used in patients with known allergies to the active substance or other components, those who have active bleeding, or in patients with severely impaired liver function. Recent history of gastrointestinal ulcers, intracranial hemorrhage, spinal or brain surgery, or patients with conditions that increase bleeding risk should also not take this drug. Furthermore, concomitant use with other anticoagulants increases the risk of bleeding, so it is advisable not to use them together. This drug contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. Patients with severely impaired renal function or those with mildly impaired liver function should use this drug with caution, especially if taking other medications that may increase bleeding risk. Elderly patients, those with low body weight, or patients undergoing spinal or epidural anesthesia may also have an increased risk of bleeding while using this drug, so careful monitoring is necessary. Due to the increased risk of bleeding, it is advisable to stop taking this medication at least 24 to 48 hours prior to surgical or invasive procedures. Temporary discontinuation may increase the risk of thromboembolism, so it's important to resume taking the medication as soon as possible. This medication is not recommended for pregnant women, and breastfeeding women should either stop breastfeeding or discontinue the medication if taking it. The safety and efficacy in pediatric patients have not yet been established. This drug may interact with other medications, including antifungals, HIV treatments, anticoagulants, and non-steroidal anti-inflammatory drugs (NSAIDs), therefore it is important to consult a healthcare provider before use. In case of an overdose, there is a significant increase in the risk of bleeding; immediate medical attention should be sought for appropriate treatment. There is minimal impact on driving or operating machinery, but caution is advised if symptoms of bleeding are present.

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

This medication must be stored in a tightly sealed container to protect it from air and moisture, at a temperature between 1 to 30 degrees Celsius. This will help maintain the drug's efficacy and safety.

Appearance

Pale yellow round film-coated tablet

Package unit

60 tablets/PTP [10 tablets/PTP x 6]