Rivaroxaban 2.5mg (Apixaban)

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 they remember and continue taking it twice daily as before. Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement: The recommended dose is 2.5 mg of this medicine taken orally twice daily. The initial dose should be taken 12 ~ 24 hours after surgery. The recommended duration of treatment for patients who have undergone hip replacement is 32 ~ 38 days. The recommended duration of treatment for patients who have undergone knee replacement is 10 ~ 14 days. 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 concomitant administration of the recommended dose of this medicine with 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. 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. Reduction of the risk of recurrent 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. When switching from a parenteral anticoagulant to this medicine, or from this medicine to a parenteral anticoagulant, the switch can be made at the time of the next scheduled dose. When switching 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, International Normalized Ratio) is less than 2.0. When switching 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 just 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. There is no clinical experience in patients on dialysis or in patients with creatinine clearance less than 15 mL/min; therefore, use of this medicine is not recommended. Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement: No dose adjustment is necessary 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), plasma concentrations of this medicine were increased in these patients; therefore, this medicine should be used with caution in these patients. 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 age ≥ 80 years or have a body weight ≤ 60kg 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. Treatment of deep vein thrombosis and pulmonary embolism/ Reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism: No dose adjustment is necessary 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), plasma concentrations of this medicine were increased in these patients; therefore, this medicine should be used with caution in these patients. 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 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, caution should be exercised when administering this medicine to such patients. Liver function tests should be performed before starting treatment with this medicine. For patients who cannot 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 blood clots by thinning the blood. While taking this medication, there may be a risk of bleeding, so symptoms or signs of bleeding must be closely monitored. If severe bleeding occurs, the medication should be stopped immediately and medical advice should be sought. This medication should not be used in patients at high risk for bleeding, such as those with bleeding disorders or who have recently had bleeding conditions or surgeries. Moreover, the risk of bleeding may significantly increase if taken with other anticoagulants, so concomitant use is not recommended. In patients with severely impaired kidney or liver function, the concentration of this medication may become elevated, increasing the risk of side effects, so caution is advised. This medication may increase the risk of bleeding when taken with certain antidepressants or non-steroidal anti-inflammatory drugs (NSAIDs); therefore, it must be reported to healthcare professionals. Elderly patients or those with low body weight are at a higher risk of bleeding and should take this medication with greater caution. Patients receiving spinal or epidural anesthesia are at risk of hematoma and nerve damage when taking this medication, so administration should be adjusted before and after anesthesia. This medication is not recommended for patients who are pregnant or breastfeeding; if planning for pregnancy or breastfeeding, one should consult a healthcare professional. Safety in pediatric patients has not been adequately established, so it is advisable not to use this medication in children. While taking this medication, it should be stopped at least 24-48 hours prior to undergoing surgery or invasive procedures, and the timing for resuming should be determined based on the risk of bleeding after the procedure. In the case of an overdose, the risk of bleeding significantly increases, so one must strictly adhere to the prescribed dosage and report any symptoms of bleeding to a healthcare professional. This medication can interact with certain drugs, so any other medications being taken should be reported to healthcare providers. While it has little effect on driving or operating machinery, caution is needed if symptoms such as bleeding or dizziness 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 avoid exposure to air or moisture. It is best stored at room temperature between 1°C and 30°C, away from extremely hot or cold locations.

Appearance

Yellow, round film-coated tablet

Package unit

60 tablets/box [(10 tablets/PTPX6)]