Apixaban 5 mg Tablets

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 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 initial dose should be taken between 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 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 of 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 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, after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between medications When switching from parenteral anticoagulant administration 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 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 Because 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 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 with serum creatinine ≥1.5 mg/dL (133 micromole/L) who are aged ≥ 80 years or have a body weight ≤ 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 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. 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 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 helps prevent blood from flowing too easily; hence, there is a risk of bleeding, and patients should be carefully monitored for signs of bleeding. If severe bleeding occurs, dosing should be immediately discontinued, and appropriate treatment should be provided if necessary. This medication should not be used in some patients, such as those with allergies to the active ingredient or active bleeding, those at high risk of bleeding due to liver disease, those with a recent history of gastrointestinal ulcers or intracranial hemorrhage, patients with certain vascular abnormalities, or those with a high risk of bleeding from cancer. Caution should be exercised if taken in combination with other anticoagulants, and patients with lactose intolerance should not take this medication. Patients with severe renal impairment or liver dysfunction, as well as those taking certain antidepressants or nonsteroidal anti-inflammatory drugs, should use this medication cautiously due to an increased risk of bleeding. Elderly patients or those with very low body weight may have a higher risk of bleeding; therefore, special attention is needed. Patients receiving spinal or epidural anesthesia should consult their healthcare provider, as this medication can cause hematomas leading to nerve damage. The safety of this medication has not been established for patients requiring thrombolysis or embolectomy, so it is not recommended in such cases. In cancer patients, due to the high risk of bleeding and thromboembolism, the risks and benefits should be carefully evaluated before using this medication. While taking this medication, symptoms such as bleeding, bruising, nosebleeds, and hematomas may occur, so any unusual symptoms should be reported to a healthcare provider immediately. Additionally, this medication can interact with other drugs; caution is needed when taken with certain antifungal, antiviral, anticonvulsant, some analgesics, and antidepressants. Before undergoing surgery or invasive procedures, this medication should be discontinued a certain time prior due to the risk of bleeding; it should be resumed according to healthcare provider instructions after the procedure. Use during pregnancy or breastfeeding is not recommended, especially during breastfeeding, as this medication can be transmitted in breast milk and pose risks to newborns, so the decision to use should be made carefully. Safety and efficacy in children have not been established, so it should not be used in pediatrics. While this medication does not significantly affect driving or operating machinery, caution is advised for symptoms of bleeding or dizziness. In cases of overdose, the risk of bleeding significantly increases; therefore, it is essential to strictly adhere to the prescribed dosage and use. Any suspicion of overdose should be reported to a healthcare provider immediately.

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

This medication must be stored in a tightly closed container to protect from air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

Pink, egg-shaped, convex film-coated tablet

Package unit

60 tablets (10 tablets/PTPX6)