AhnGuk Apixaban Tablets 5 mg

Adult dose

This medicine should be taken 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. 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 in patients who have undergone hip replacement surgery is 32 ~ 38 days. The recommended duration of treatment in patients who have undergone knee replacement surgery is 10 ~ 14 days. Reduction in 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 coadministration of the recommended dose of this medicine with antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation and acute coronary syndrome and/or undergoing percutaneous coronary intervention. (Refer to ‘5. General Precautions, 1) Interactions with other drugs that affect hemostasis’ and ‘12. Clinical Trial Information, 2) Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, AUGUSTUS trial’ under Precautions for Use.) 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 in 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 treatment should be initiated after completion of at least 6 months of treatment with this medicine or another anticoagulant. 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. 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. Switching from this medicine to vitamin K antagonist therapy To switch 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 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. 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 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) indicates that blood concentrations of this medicine increased in these patients; therefore, this medicine should be administered with caution in these patients. Reduction in 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 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 in 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) indicates that blood concentrations of this medicine increased in these patients; therefore, this medicine should be administered 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 administered 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 these patients. Liver function tests should be performed before starting this medicine. 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 thrombosis by preventing blood from clotting. During the use of this drug, patients should be closely monitored for signs of bleeding, and it should be administered with caution in patients at high risk of bleeding. If serious bleeding occurs, discontinue this medication immediately and consult with medical personnel. This drug should not be taken by patients with an allergic reaction, active bleeding, or specific liver diseases or coagulopathy that pose a high risk of bleeding. Additionally, patients with a history of gastrointestinal ulcers, intracranial hemorrhage, or spinal or brain surgery should not be treated with this drug. This drug may increase the risk of bleeding when taken with other anticoagulants, so concurrent administration should be avoided. Patients with genetic problems related to lactose should also not take this drug. Patients with severe renal or liver impairment, elderly patients, and underweight patients require special precaution when taking this medication. Particularly, patients receiving spinal or epidural anesthesia are at risk for serious nerve damage due to bleeding, so strict medical supervision is necessary before and after taking this drug. This drug may have various bleeding-related side effects, including nosebleeds, bruising, hematomas, and gastrointestinal bleeding. Abnormal reactions such as liver function abnormalities, allergic reactions, hematuria, and muscle hemorrhage have also been reported. This drug interacts with many other medications, and caution should be taken especially when taken with specific antifungals, antivirals, anticoagulants, antiplatelets, and some analgesics as this may increase the risk of bleeding. Before surgeries or invasive procedures, this medication should be discontinued for a certain period to reduce the risk of bleeding, and resuming medication post-procedure depends on the situation. Pregnant or breastfeeding women are not recommended to take this medication, and breastfeeding may need to be discontinued during treatment. Safety and efficacy in children have not been established. This medication does not significantly affect driving or operating machinery, but caution is necessary due to the risk of bleeding. In cases of overdose, the risk of bleeding is significantly increased, so medical personnel should be notified immediately, and since there is no specific antidote, treatment to control bleeding may be necessary. It is important to immediately consult with medical personnel if symptoms of bleeding or adverse reactions occur during the use of this drug.

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

This medication should be stored in a tightly sealed container to protect it from exposure to air or moisture. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

Pink egg-shaped, both sides convex film-coated tablet

Package unit

60 tablets/box [(10 tablets/PTP×6)]