Yuhan Rivaroxaban Tablet 2.5 mg

Adult dose

This medicine may be administered with or without food. 1. Adults 1) Reduction in the incidence of atherothrombotic events (death due to cardiovascular causes, myocardial infarction) in patients who have experienced acute coronary syndrome with elevated cardiac biomarkers, when administered concomitantly with aspirin or with aspirin and clopidogrel The recommended dose of this medicine is 2.5mg twice daily. Patients should take aspirin 75-100mg once daily, or aspirin 75-100mg once daily and clopidogrel 75mg, together with this medicine. Treatment for at least 24 months is recommended. Since the risk of cardiovascular symptoms persists in patients who have experienced acute coronary syndrome, extending the treatment period may be beneficial. Treatment with this medicine 2.5mg should be initiated as soon as possible after the acute coronary syndrome event has stabilized (including revascularization). Treatment may be initiated as early as 24 hours after hospitalization, once parenteral anticoagulant therapy has been discontinued as usual. 2) Coronary artery disease (CAD) or peripheral artery disease (PAD) The recommended dose of this medicine is 2.5mg twice daily, and aspirin 75-100mg once daily should be taken together with this medicine. The duration of treatment with this medicine should be determined by regularly assessing the condition of each individual patient, taking into account the risk of bleeding compared with the risk of thrombotic events. During treatment with this medicine, for patients who experience an acute thrombotic event or undergo a vascular procedure, and for patients requiring dual antiplatelet therapy, continued administration of this medicine 2.5mg twice daily should be assessed according to the antiplatelet therapy and the type of thrombotic event or vascular procedure. The efficacy and safety of concomitant use of this medicine with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Concomitant use of this medicine with dual antiplatelet therapy has not been studied in patients with coronary artery disease or peripheral artery disease. 3) If you forget to take this medicine If you forget to take this medicine, continue with the recommended dose of 2.5mg at the next scheduled dosing time. The daily dose must not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine Regardless of the dose, the INR value will be falsely elevated after taking this medicine. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medicine. 2) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this medicine to a vitamin K antagonist. Adequate anticoagulation must be maintained continuously when switching to another anticoagulant. Note that this medicine may affect the increase in INR. Patients switching from this medicine to a vitamin K antagonist should receive both medicines until INR≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer the dose of the vitamin K antagonist according to INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, INR should not be tested until 24 hours after taking this medicine. Once this medicine is discontinued, INR may be tested after 24 hours have elapsed since the last dose. 3) Switching from a parenteral anticoagulant to this medicine For patients receiving a parenteral anticoagulant, initiate this medicine 0~2 hours before the time of the next scheduled parenteral dose (e.g., low molecular weight heparin), or at the time of discontinuation of a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 4) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and initiate the parenteral anticoagulant at the time of the next dose of this medicine. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment with a creatinine clearance of 50-80 mL/min. Since there is no clinical experience in patients with severe renal impairment with a creatinine clearance of less than 15 mL/min, administration of this medicine is not recommended. 1) Reduction in the incidence of atherothrombotic events (death due to cardiovascular causes, myocardial infarction) in patients who have experienced acute coronary syndrome with elevated cardiac biomarkers, when administered concomitantly with aspirin or with aspirin and clopidogrel No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the blood concentration of this medicine increased significantly; therefore, administer this medicine with caution. 4. Patients with hepatic impairment Avoid administration of this medicine in patients with liver disease associated with coagulopathy and in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 5. For patients unable to swallow tablets, immediately before use, this medicine may be crushed and mixed with water or a beverage such as applesauce for oral administration. This medicine may also be crushed and administered with a small amount of water through a gastric tube. Before administering this medicine through a gastric tube, confirm that the tube is properly positioned, and flush the tube with water after administration.

This medication is an anticoagulant that helps prevent blood from clotting too easily. During treatment with this medication, bleeding may occur, so signs of bleeding should be monitored closely. If severe bleeding occurs, the use of this medication should be discontinued, and it should be administered cautiously to patients at higher risk of bleeding. This medication should not be used in patients with certain diseases or conditions. For example, patients with hypersensitivity to this medication, those with severe bleeding, patients with liver disease, and women who are pregnant or nursing, as well as patients with certain genetic disorders, should avoid this medication. Caution is also advised for patients who have recently had gastrointestinal ulcers, intracranial bleeding, or surgeries involving the brain or spinal cord, as well as those with malignancies that pose a high bleeding risk. When used in conjunction with other anticoagulants or specific antifungals, the risk of bleeding may increase, so a consultation with a doctor is essential. Patients with impaired kidney function or a history of bleeding disorders, uncontrolled hypertension, or gastrointestinal ulcers should also be cautious when using this medication. Adverse reactions such as bleeding, anemia, skin rash, liver function abnormalities, etc. may occur, so any unusual symptoms should be reported to a healthcare professional immediately. If severe skin rash, mucosal ulcerations, high fever, etc. occur, the medication should be discontinued immediately and a doctor's evaluation sought. This medication may pose risks to the fetus during pregnancy, so women planning to become pregnant should consult their doctor, and contraception is advised during treatment. Nursing mothers should also avoid using this medication. In elderly patients, drug concentration may increase, but no specific dose adjustment is needed; however, the risk of bleeding may be heightened. This medication is not recommended for children or adolescents under 18 years of age. In case of overdose, the risk of bleeding increases, and immediate evaluation and treatment by healthcare professionals is required. Caution is advised when driving or operating machinery, as drowsiness or dizziness may occur during treatment. If surgical or invasive procedures are planned, this medication should be discontinued at least several days prior to the procedure to reduce the risk of bleeding, and appropriate steps should be taken to minimize this risk. Regular checks for bleeding symptoms and anemia are important during treatment.

Bleeding, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, overall decrease in strength and energy, discomfort, localized edema, liver impairment, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increased transaminases, increased bilirubin in the blood, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stool, black stool, myocardial infarction, arthralgia, unspecified bleeding, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membrane colitis, asthma, pulmonary edema, pleural effusion, influenza-like symptoms, drug hypersensitivity reaction, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, cough-related diseases, asthma, laryngitis, dysphagia, bowel motility disorder, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urination disorders, renal stones, bladder carcinoma, prostatic hyperplasia, drug hypersensitivity reaction, Stevens-Johnson syndrome, postoperative syncope, drowsiness

This medication should be stored tightly closed in an airtight container to protect it from air or moisture. It is also best to store the medication at room temperature between 1°C and 30°C, avoiding excessively hot or cold areas.

Appearance

Pale yellow round film-coated tablet

Package unit

100 tablets/box [10 tablets/PTP x 10]