Apixaban 2.5 mg Tablet (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 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 orally twice daily. The first dose should be administered 12 ~ 24 hours after surgery. The recommended duration of treatment is 32 ~ 38 days for patients who have undergone hip replacement surgery. The recommended duration of treatment is 10 ~ 14 days for patients who have undergone knee replacement surgery. 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 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 concomitant administration of the recommended dose of this medicine with antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who have acute coronary syndrome and/or undergo percutaneous coronary intervention. (See “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 recurrent deep vein thrombosis and pulmonary embolism The recommended dose is 2.5mg of this medicine orally twice daily, to be administered after completing 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 may 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 other vitamin K antagonist therapy 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 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 in patients on dialysis or with creatinine clearance less than 15 mL/min, as there is no clinical experience in these patients. 1) 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 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 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 recurrent 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 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 coagulation disorders 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 greater than 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. 5. Patients unable to swallow tablets For patients unable to 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 an anticoagulant that prevents or treats clot formation by inhibiting excessive blood coagulation. Patients must be especially cautious of bleeding symptoms while taking this medicine; if there is significant bleeding, intake should be stopped immediately and healthcare personnel should be consulted. This medication is contraindicated in patients with hypersensitivity to it or those with active bleeding, severely impaired liver function, or those at high risk of bleeding, such as patients with recent gastrointestinal ulcers or intracerebral hemorrhage. Patients with severely impaired renal function or patients with mild to moderate liver impairment should use this drug with caution. When used in combination with other antiplatelet agents or non-steroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors (SSRIs), the risk of bleeding may increase. Patients receiving spinal or epidural anesthesia should be particularly careful when taking this drug as it increases the risk of neurological bleeding and potential neurological damage. This medication is not recommended during pregnancy, and if breastfeeding, it is best to either stop breastfeeding or discontinue the medication. Before any surgical or invasive procedures, this medication should be stopped for a certain period to reduce the risk of bleeding, and it should be resumed as soon as possible after bleeding is controlled. This medication may interact with other drugs, particularly CYP3A4 and P-gp inhibitors or inducers, anticoagulants, and antiplatelet agents. The risk of bleeding may increase significantly in the case of overdose, and as there is no specific antidote, any bleeding symptoms should be reported to healthcare personnel immediately. While taking this medication, it is crucial to observe bleeding symptoms rather than rely solely on regular blood coagulation tests, as common adverse reactions include bleeding, bruising, and nosebleeds. Elderly or underweight patients must be monitored closely due to the increased risk of bleeding, and if anticoagulant therapy is stopped, the risk of thrombosis increases, so it should preferably be avoided or rapidly re-administered if necessary. This medication has a minor effect on driving or operating machinery, but caution should be exercised regarding physical symptoms from bleeding.

bleeding, contusion, nosebleed, hematoma, anemia, thrombocytopenia, hypersensitivity, allergic edema, anaphylactic reaction, cerebral hemorrhage, ocular hemorrhage, hypotension, intraperitoneal bleeding, epistaxis, hemoptysis, airway bleeding, nausea, gastrointestinal bleeding, hemorrhoidal bleeding, oral bleeding, melena, rectal bleeding, gum bleeding, retroperitoneal bleeding, transaminase increase, aspartate aminotransferase increase, gamma-glutamyltransferase increase, abnormal liver function tests, increased serum alkaline phosphatase, increased serum bilirubin, skin rash, muscle bleeding, hematuria, abnormal vaginal bleeding, urogenital bleeding, site of administration bleeding, stool occult blood positive, post-procedural bleeding, wound secretion, incision site bleeding, traumatic bleeding, post-procedural bleeding, incision site bleeding, hepatitis, biliary disorder, fracture, ligament disorder, coronary artery surgery, post-operative bleeding, traumatic hematoma, hypernatremia, metabolic acidosis, generalized weakness, dehydration, sepsis, acute renal failure, urinary retention, neural infarction, abnormal renal function, uterine bleeding, vaginal bleeding, conjunctivitis, visual disturbances, unspecified adenocarcinoma, renal cancer, cholangiocarcinoma, aortic valve insufficiency, aortic stenosis, arterial stenosis, pericardial effusion, angina pectoris, syndrome of inappropriate anti-diuretic hormone secretion, paroxysmal supraventricular tachycardia, cardiac arrest, colitis, gastroesophageal reflux, gastritis, hematemesis, anal fissure, heart failure, weakness, death, deterioration of condition, fever, drowsiness, convulsions, polyneuropathy, headache, hemiparesis, dizziness, unilateral weakness, coma, soft tissue inflammation, subarachnoid hemorrhage, intracranial hemorrhage, vitreous hemorrhage, emphysema, pleural effusion, fall, surgical intervention, eating disorder, atrial fibrillation, hemorrhagic gastric ulcer, melena, cerebral infarction, cerebral hemorrhage, pneumonia, shortness of breath, vomiting, diarrhea, esophagitis, benign gastrointestinal neoplasm, dental disease, constipation, abdominal pain, dyspepsia, chest pain, insomnia, loss of appetite, itchy rash, petechiae, congestion, flushing, palpitations, migraine

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it is advisable to keep the medication at room temperature between 1°C and 30°C, avoiding excessively hot or cold locations. This helps maintain the drug's efficacy over time.

Appearance

Pale yellow round film-coated tablet

Package unit

60 tablets/PTP (10 tablets/PTP x 6) - 60 tablets/PTP [60 tablets/PTP (10 tablets/PTP x 6)]