Uniqsaban 2.5 mg (Apixaban)

Adult dose

This medicine may be taken with water, regardless of 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 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. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose is 5 mg of this medicine 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 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 an antiplatelet agent after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who also 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 orally twice daily for 7 days, followed by 5mg orally twice daily. Reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism: The recommended dose is 2.5mg of this medicine 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 parenteral anticoagulant therapy to this medicine or from this medicine to parenteral anticoagulant therapy, 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 other vitamin K antagonist therapy 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 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. As there is no clinical experience in patients on dialysis or patients with creatinine clearance less than 15 mL/min, administration 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. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), blood concentrations of this medicine were increased in these patients; therefore, this medicine should be administered 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), blood concentrations of this medicine were 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. 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. 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 thrombus formation by inhibiting blood clotting. During treatment, there may be a risk of bleeding, so patients should closely monitor for signs of bleeding such as nosebleeds, hematuria, black stools, and bleeding from wounds. If serious bleeding occurs, the medication should be discontinued immediately and medical attention sought. While routine monitoring of drug concentration through specific blood tests is not necessary, measurement may be helpful in cases of overdose or urgent surgical situations. This medication should not be taken by individuals with a history of severe liver function impairment, recent gastrointestinal bleeding or intracranial hemorrhage, or those with certain vascular abnormalities or high risks of bleeding. Additionally, caution is needed when taken with other anticoagulants due to increased bleeding risk. Patients with severe renal impairment, mildly impaired liver function, underweight patients (<60 kg), elderly patients, and those taking certain antidepressants or nonsteroidal anti-inflammatory drugs may have a higher risk of bleeding and should use this medication cautiously. Patients receiving spinal or epidural anesthesia are at risk of hematoma formation and should take special care with this drug. It is not recommended for use in pregnant or breastfeeding women, and safety in pediatric populations has not been established. Additional caution is warranted when combined with other medications that may increase the risk of bleeding, such as acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, and certain antidepressants. The medication should be discontinued for a specified time before undergoing surgery or invasive procedures; after the procedure, resuming the medication should take into account the risk of bleeding and necessity of treatment. Overdose significantly increases the risk of bleeding, so immediate medical assistance should be sought, and activated charcoal or special treatment may be administered if necessary. This medication does not significantly impact driving or machine operation, but caution is advised if bleeding or other abnormal symptoms occur. There may be drug interactions, so inform your doctor or pharmacist if you are taking other medicines.

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

This medication may be sensitive to air and moisture, so it must be stored in a tightly closed container. The appropriate storage temperature is between 1 to 30 degrees Celsius, avoiding extremely hot or cold places.

Appearance

Yellow round film-coated tablet

Package unit

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