Chodang Apixaban Tablet 5mg

Adult dose

This medicine may 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 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 first 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 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 with antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who also 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 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 medicine taken orally twice daily, to be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between drugs 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. 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 the vitamin K antagonist, perform an INR test 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 greater. 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 necessary for 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 for 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 necessary for 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 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 administered with caution to these patients. Liver function tests should be performed before starting this medicine. 5. Patients who cannot swallow tablets For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage 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 is used to prevent or treat the formation of clots by inhibiting blood coagulation. During treatment, it is crucial to monitor for signs of bleeding, as bleeding may occur. If severe bleeding occurs, the medication should be discontinued immediately. This medication should not be administered to patients with a known allergy, currently experiencing severe bleeding, those with severely impaired liver function, or patients with a history of gastrointestinal bleeding or cerebral hemorrhage. Additionally, caution should be exercised when used in conjunction with other anticoagulants. It should be administered cautiously to patients with severely impaired renal function or mild liver impairment, as well as to those taking other medications that can affect blood coagulation. Special caution is required for elderly patients, low body weight individuals, and patients undergoing spinal or epidural anesthesia. Bleeding, bruising, epistaxis, hematoma, anemia, thrombocytopenia, hypersensitivity, allergic edema, ocular bleeding, bleeding, hematoma, hypotension, non-bleeding, hemoptysis, nausea, gastrointestinal bleeding, rectal bleeding, oral bleeding, bloody stools, rectal bleeding, gum bleeding, retroperitoneal bleeding, increased transaminases, increased aspartate aminotransferase, increased gamma-glutamyltransferase, abnormalities in liver function tests, increased serum alkaline phosphatase may occur during treatment. Before undergoing surgery or invasive procedures, the medication should be discontinued for a specific period, and it should not be resumed until the risk of bleeding has sufficiently diminished following the procedure. Pregnant or breastfeeding women are advised against using this medication, and its safety in pediatric patients has not been established. This medication may interact with other drugs; therefore, if other medications are being taken, it is crucial to inform the healthcare provider or pharmacist. Especially, caution is needed when combined with certain antifungals, antivirals, anticoagulants, antiplatelet drugs, and non-steroidal anti-inflammatory drugs. In cases of overdose, the risk of bleeding increases significantly, so it is essential to follow the prescribed dosage and regimen as directed by a healthcare professional. This medication does not significantly impair driving or operating machinery; however, caution is advised due to the risk of bleeding. If symptoms of bleeding or neurological abnormalities arise during treatment, immediate consultation with a healthcare professional is necessary.

• hemorrhage
• contusion
• epistaxis
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylactic reaction
• intracerebral hemorrhage

Store this medication in a tightly closed container as it may be sensitive to air or moisture. It is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication over time.

Appearance

Pink, oval, biconvex film-coated tablets

Package unit

60 tablets/PTP (10 tablets/PTP x 6)