Ocosavan Tablet 2.5 mg (Apixaban)

Adult dose

This medication should be taken with water, with or without food. If a patient forgets to take a dose, they should take this medication as soon as they remember 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 medication taken 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 of this medication 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 medication 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 medication 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 medication taken orally twice daily, and it should be given after completion of at least 6 months of treatment with this medication or another anticoagulant. 2. Switching between medications When switching from parenteral anticoagulant therapy to this medication or from this medication 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 medication To switch from vitamin K antagonist therapy to this medication, discontinue warfarin or another vitamin K antagonist and start this medication when the international normalized ratio (INR, International Normalized Ratio) is below 2.0. 2) Switching from this medication to vitamin K antagonist therapy To switch from this medication to vitamin K antagonist therapy, continue taking this medication for 2 days after starting the vitamin K antagonist. After 2 days of concomitant treatment with this medication and the vitamin K antagonist, measure the INR just before the scheduled dose of this medication, and continue concomitant treatment with this medication 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 medication 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) has shown increased blood concentrations of this medication in these patients; therefore, this medication 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 weigh ≤ 60kg should receive 2.5 mg of this medication twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive 2.5 mg of this medication 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) has shown increased blood concentrations of this medication in these patients; therefore, this medication should be administered with caution in these patients. 4. Hepatic impairment This medication 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 medication should be administered with caution. Use of this medication 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 at least 1.5 times the upper limit of normal were excluded from clinical trials; therefore, caution should be exercised when administering this medication to these patients. Liver function tests should be performed before starting this medication. 5. For patients who cannot swallow tablets, immediately before use this medication may be crushed and mixed with water or a beverage such as applesauce for oral administration. This medication may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This drug is anticoagulant, used to prevent or treat thrombosis. During the intake of this medication, bleeding may occur, so notify the healthcare provider immediately if signs of bleeding occur. If bleeding worsens, the medication should be discontinued, and appropriate treatment should be provided if necessary. This medication should not be administered to patients with certain diseases or conditions, such as those with bleeding disorders or active bleeding, severe liver impairment, and patients with a history of high bleeding risk. Additionally, this medication contains lactose, so patients with genetic problems like lactose intolerance should avoid it. Patients with very poor kidney function or moderate to severe liver function should be administered this medication cautiously, as the risk of bleeding may increase when used with certain other medications. Especially in older adults, underweight patients, and patients receiving spinal or epidural anesthesia, the risk associated with bleeding should be managed carefully. This medication should be discontinued for a certain period before undergoing surgery or invasive procedures, and after the procedure, the resumption of the medication should consider the risk of bleeding and the patient's condition. Administration is not recommended for pregnant or breastfeeding women; if breastfeeding, the mother should either stop nursing or discontinue the medication. The safety and effectiveness of this drug have not been adequately established in pediatric patients. There may be interactions with certain medications during use, so patients must inform healthcare providers if they are taking other drugs. In case of overdose, the risk of bleeding significantly increases, so contact a medical institution immediately and receive appropriate treatment.

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

Store this medication in a tightly closed container to prevent air exposure and keep it at temperatures between 1°C and 30°C. This helps maintain the drug's effects.

Appearance

Yellow round film-coated tablet

Package unit

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