Barelto 2.5 mg (Rivaroxaban)

Adult dose

This medicine may be taken 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 accompanied by elevated cardiac biomarkers, when administered in combination 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 patients who have experienced acute coronary syndrome remain at risk of cardiovascular events, extending the duration of treatment may be beneficial. Treatment with this medicine at 2.5mg should be initiated as soon as possible after the acute coronary syndrome event has stabilized (including revascularization). Treatment may be started as early as 24 hours after hospitalization, once parenteral anticoagulant therapy has been appropriately discontinued. 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 each patient's condition, taking into account the risk of bleeding relative to 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 who require dual antiplatelet therapy, the decision to continue this medicine at 2.5mg twice daily should be assessed according to the antiplatelet regimen and the type of thrombotic event or vascular procedure. The efficacy and safety of this medicine in combination 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 taking the recommended dose of 2.5mg at the next scheduled dose. Do not take a double dose to make up for a missed dose. 2. Switching between medicines 1) Switching from a vitamin K antagonist to this medicine After taking this medicine, INR values will be falsely elevated, regardless of the dose. INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used for this purpose. 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 should be maintained continuously while switching to another anticoagulant. Note that this medicine may affect the elevation of INR. Patients switching from this medicine to a vitamin K antagonist should receive both medicines until the INR is ≥2.0. During the first 2 days after the switch, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist according to INR test results. However, patients receiving this medicine together with a vitamin K antagonist should not undergo INR testing until 24 hours after taking this medicine. Once this medicine has been discontinued, INR testing may be performed 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine For patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low molecular weight heparin), or when discontinuing a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 4) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start the parenteral anticoagulant at the time of the next scheduled 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. Use of this medicine is not recommended in patients with severe renal impairment with a creatinine clearance of less than 15 mL/min, as there is no clinical experience in these patients. 1) Reduction in the incidence of atherothrombotic events (death due to cardiovascular causes, myocardial infarction) in patients who have experienced acute coronary syndrome accompanied by elevated cardiac biomarkers, when administered in combination 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 blood levels of this medicine are significantly increased; therefore, administer this medicine with caution. 4. Patients with hepatic impairment Avoid administering this medicine to patients with liver disease associated with coagulation disorders and to 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 who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as applesauce, and taken orally. This medicine may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this medicine through a gastrointestinal tube, confirm that the tube is properly positioned, and flush the tube with water after administration.

This medication is an anticoagulant that prevents blood clotting. Bleeding may occur during treatment, so signs or symptoms of bleeding should be closely monitored. If severe bleeding occurs, the use of this medication should be discontinued immediately and medical attention sought. This medication should not be administered to patients with certain diseases or conditions, such as those with bleeding disorders, severe liver dysfunction, or women who are pregnant or breastfeeding, and patients with certain genetic metabolic disorders. Patients with reduced renal function or those with conditions that elevate bleeding risk, or those taking other drugs that may enhance bleeding should use this medication with caution. Various adverse reactions may occur while taking this medication, particularly bleeding, anemia, gastrointestinal disturbances, skin rash, and liver function abnormalities. If severe bleeding symptoms, allergic reactions, or severe skin reactions occur, immediate notification to healthcare professionals is required. This medication can interact with other drugs, so any other medications being taken must be disclosed to healthcare professionals, particularly when combined with antifungals, anticoagulants, antiplatelet agents, and certain antibiotics. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication and use appropriate contraception during treatment. Elderly patients may have increased blood levels of this medication, but no special dosage adjustments are needed; however, the risk of bleeding may be higher, requiring caution. Safety and efficacy in children and adolescents have not been established, so use is not recommended. In case of overdose, the risk of bleeding increases; therefore, seek medical help immediately for appropriate treatment. Caution is required while driving or operating machinery during treatment; if symptoms like dizziness or drowsiness occur, those activities should be avoided. If surgery or invasive procedures are planned, notify healthcare professionals of this medication's use, as it may be necessary to stop taking it for a certain period before the procedure. Patients receiving peripheral nerve blocks (epidural or spinal anesthesia) require special care due to the risk of nerve damage from bleeding.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomachache, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy reduction, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, pseudoaneurysm, increased transaminases, increased blood bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminase, increased bilirubin conjugate, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, hematuria, menorrhagia, renal impairment, epistaxis, hemoptysis, itching, rash, petechiae, cutaneous and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions with systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, fever, unspecified bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, black stools, deep vein thrombosis, joint dislocation, arthralgia, Pseudomonas wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulcer, high fever, severe dysphagia, angina, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, black stools, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, gastrointestinal motility disorder, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urinary disorders, kidney stones, bladder carcinoma, prostatic hyperplasia, flu-like syndrome, drug hypersensitivity reaction, Stevens-Johnson syndrome, syncope, drowsiness

Store this medication in a tightly closed container to prevent exposure to air or moisture, at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness over time.

Appearance

Bright yellow, round film-coated tablets

Package unit

30 tablets (10 tablets/PTP packaging x 3)