Eriquin Tablet 2.5 mg (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 immediately and continue taking it twice daily as before. 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 taken 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 coadministration of the recommended dose of this medicine and an antiplatelet agent after hemostasis has been achieved in patients with nonvalvular atrial fibrillation accompanied by acute coronary syndrome and/or percutaneous coronary intervention. (See ‘5. General Precautions, 1) Interactions with Other Drugs Affecting 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 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 between medications 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. 1) Switching from vitamin K antagonist therapy to this medicine When switching 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. 2) Switching from this medicine to vitamin K antagonist therapy When switching 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, 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 As there is no clinical experience in patients receiving dialysis or patients with creatinine clearance less than 15 mL/min, use 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 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 patient groups; therefore, this medicine should be used 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 age ≥ 80 years or have 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. 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 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 patient groups; therefore, this medicine should be used 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 used 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 ≥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 treatment with 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 clot formation by inhibiting blood coagulation. During treatment, there may be a risk of bleeding, so signs of bleeding should be monitored closely. If severe bleeding occurs, the medication should be discontinued immediately. This medication should not be used in patients at high risk for bleeding, such as those with coagulation disorders, recent significant bleeding, a history of certain liver diseases, etc. Additionally, concurrent use with other anticoagulants is not recommended. This medication contains lactose, so patients with lactose intolerance should not take it. Patients with severely impaired renal or hepatic function should use this medication cautiously. Special attention is required for the elderly, underweight patients, and those undergoing specific nerve anesthesia or spinal puncture, as they are at a higher risk of bleeding. This medication may interact with various drugs, so if other medications are being taken, a consultation with a doctor or pharmacist is necessary. Pregnant or breastfeeding women should avoid this medication, and if breastfeeding, the decision to take the medication should be made with caution. The safety in pediatric patients has not been sufficiently confirmed. During treatment, if any unusual symptoms appear, such as severe bleeding, bruising, nosebleeds, hematuria, etc., medical personnel should be informed immediately. Before undergoing surgery or invasive procedures, this medication should be discontinued at least 24 to 48 hours in advance, and it may be resumed post-surgery based on the situation. In cases of overdose, there is an increased risk of bleeding, necessitating immediate emergency treatment. This medication does not significantly affect driving or machine operation, but caution should be exercised considering the risk of bleeding.

Bleeding, contusion, nosebleed, hematoma, anemia, thrombocytopenia, hypersensitivity, allergic edema, anaphylaxis, cerebral hemorrhage, ocular hemorrhage, hypotension, intra-abdominal bleeding, epistaxis, hemoptysis, airway hemorrhage, nausea, gastrointestinal bleeding, hemorrhoidal bleeding, oral bleeding, blood in stool, rectal bleeding, gum bleeding, retroperitoneal bleeding, increased transaminases, increased aspartate aminotransferase, increased gamma-glutamyltransferase, abnormal liver function tests, increased serum alkaline phosphatase, increased serum bilirubin, skin rash, muscle bleeding, hematuria, abnormal vaginal bleeding, urogenital bleeding, bleeding at administration site, positive occult blood, post-procedural bleeding, wound exudate, incision site bleeding, traumatic bleeding, post-procedural bleeding, incision site bleeding, hepatitis, biliary disorder, fracture, ligament injury, coronary artery surgery, postoperative bleeding, traumatic hematoma, hypernatremia, metabolic acidosis, systemic weakness, dehydration, sepsis, acute renal failure, urinary retention, cerebral infarction, renal dysfunction, uterine bleeding, vaginal bleeding, conjunctivitis, visual disturbances, unspecified adenocarcinoma, renal cancer, gallbladder duct carcinoma, aortic valve insufficiency, aortic stenosis, arterial stenosis, pericardial effusion, angina, syndrome of inappropriate antidiuretic hormone secretion, paroxysmal supraventricular tachycardia, cardiac arrest, enteritis, gastroesophageal reflux, gastroenteritis, hematemesis, anal fissure, heart failure, weakness, death, worsening condition, fever, drowsiness, seizures, polyneuropathy, headache, hemiplegia, dizziness, unilateral paralysis, coma, soft tissue infection, subarachnoid hemorrhage, intracranial hemorrhage, vitreous hemorrhage, emphysema, pleural effusion, pneumonia, dyspnea, vomiting, colitis, diarrhea, esophagitis, benign gastrointestinal neoplasm, gastroesophageal reflux, gastrointestinal bleeding, gastroenteritis, dental disease, anal fissure, orthostatic hypotension, leg pain, peripheral edema, fatigue, insomnia, loss of appetite, pruritic rash, maculopapular rash, congestion, flushing, palpitations, constipation, abdominal pain, indigestion, chest pain

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

Appearance

Yellow round film-coated tablet

Package unit

10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6]