Chodang Apixaban Tablet 2.5 mg

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 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 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 concomitant administration of the recommended dose of this medicine with antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation accompanied by acute coronary syndrome and/or percutaneous coronary intervention. (Refer to ‘5. General precautions, 1) Interactions with other drugs that affect hemostasis’ under Precautions for use and ‘12. Clinical trial information, 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, AUGUSTUS trial’.) 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, and it should be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching medications When switching from parenteral anticoagulant therapy 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, International Normalized Ratio) 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 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. 3. Renal impairment Administration of this medicine is not recommended because there is no clinical experience in patients receiving dialysis or in patients with a creatinine clearance of less than 15 mL/min. 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) 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 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 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. 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) 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 required 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, caution should be exercised when administering this medicine to such 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 and mixed with water or a beverage such as applesauce for oral administration immediately before use. 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 coagulation. During treatment, there is a risk of bleeding, so close observation for any bleeding symptoms is necessary. If severe bleeding occurs, discontinue the use of this medication immediately. Patients with an allergy to this medication, those currently experiencing significant bleeding, patients with severe liver dysfunction, or those with a history of gastrointestinal ulcers or cerebral hemorrhage should not take this medication. Also, it should be avoided in combination with other anticoagulants. Particular caution is advised when using this medication in patients with severely impaired kidney function, mildly impaired liver function, elderly patients, or those with low body weight. Especially patients undergoing spinal or epidural anesthesia are at increased risk of serious neurological damage due to bleeding and should take extra precautions. This medication can cause various side effects such as bleeding, bruising, nosebleeds, hematomas, anemia, thrombocytopenia, hypersensitivity, allergic swelling, ocular bleeding (including conjunctival hemorrhage), hypotension, nausea, gastrointestinal bleeding, hemorrhoidal bleeding, oral bleeding, blood in stool, rectal bleeding, gum bleeding, retroperitoneal bleeding, increased transaminases, increased aspartate aminotransferase, increased gamma-glutamyltransferase, abnormalities in liver function tests, increased serum alkaline phosphatase. If any unusual symptoms occur, immediate consultation with medical personnel is necessary. There may be interactions with other drugs, so especially if taking antiplatelet agents, certain antibiotics, antifungals, antidepressants, or anti-inflammatory pain relievers, one must inform their doctor or pharmacist. Use of this medication is not recommended for pregnant or breastfeeding women, and safety and efficacy in pediatric patients have not been established. Before undergoing surgery or invasive procedures, a certain period of discontinuation of this medication is necessary, and it should be resumed only after the risk of bleeding has decreased post-procedure. In case of overdose, the risk of bleeding significantly increases, so accurate dosing should be maintained as directed by a physician, and if overdose is suspected, medical attention should be sought immediately.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture, at room temperature between 1 and 30 degrees Celsius. This ensures the maintenance of the medication's efficacy and safety.

Appearance

Light yellow, round film-coated tablet

Package unit

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