Pavis Apixaban Tablet 2.5 mg

Adult dose

Take this medicine with water, with or without food. If a patient misses a dose, they should take this medicine immediately 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 taken 12 ~ 24 hours after surgery. The recommended duration of treatment is 32 ~ 38 days in patients who have undergone hip replacement surgery. The recommended duration of treatment is 10 ~ 14 days in patients who have undergone knee replacement surgery. 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, for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics, the recommended dose 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. 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 undergo percutaneous coronary intervention. 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, and treatment should be started after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between medications When switching from parenteral anticoagulant therapy to this medicine or from this medicine to parenteral anticoagulant therapy, 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 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 Because there is no clinical experience in patients on dialysis or in patients with a 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 required in patients with mild or moderate renal impairment. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) has shown increased plasma concentrations of this medicine in these patients; therefore, this medicine should be used 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 take 2.5 mg of this medicine twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should take 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 required in patients with mild or moderate renal impairment. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) has shown increased plasma concentrations of this medicine in these patients; therefore, this medicine should be used with caution in these patients. 4. Hepatic impairment This medicine should not be used in 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 used with caution. Use 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 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 used with caution in 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 and mixed with water or a beverage such as applesauce for oral administration. 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 the formation of blood clots by inhibiting blood clotting. However, there is a risk of bleeding, so any symptoms of bleeding should be reported to a healthcare professional immediately. If severe bleeding occurs, the use of this medication should be discontinued. Patients with allergies to this medication, those currently experiencing bleeding, those with liver dysfunction, or those with certain diseases that increase bleeding risk should not take this medication. Caution is also necessary when used with other anticoagulants. Patients with severe renal impairment or those with mild liver dysfunction should use this medication with caution. Additionally, the risk of bleeding may increase when used with certain antidepressants or non-steroidal anti-inflammatory drugs. Older adults or those with low body weight also have a higher risk of bleeding and should be monitored closely. Patients undergoing spinal or epidural anesthesia may be at risk of developing hematomas while taking this medication, and neurological symptoms should be monitored frequently, as well as maintaining certain intervals when removing catheters. Use of this medication is not recommended or should be evaluated carefully in some patients with pulmonary embolism or cancer. Common side effects include bleeding, bruising, nosebleeds, hematomas, etc., and immediate medical consultation is needed for severe bleeding or other abnormal symptoms. The bleeding risk may increase when taken with other medications that elevate bleeding risk, so all current medications must be disclosed. Before undergoing surgery or invasive procedures, the use of this medication should be discontinued for a certain period, and after surgery, the timing for resuming use should be determined considering the risk of bleeding. Use of this medication during pregnancy or breastfeeding is not recommended, especially while breastfeeding, where consultation with a doctor is necessary. This medication is not used in children as safety and efficacy have not been established. This medication does not significantly affect driving or operating machinery, but the bleeding risk should always be kept in mind. In case of overdose, the risk of bleeding increases significantly, so immediate notification to healthcare professionals is necessary, and specific antidotes are not available, so treatment to control bleeding may be required.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain storage temperatures between 1°C and 30°C to preserve the medication's efficacy and safety.

Appearance

Yellow round film-coated tablet

Package unit

60 tablets/box [(10 tablets/PTP)*6]