Xarelto 2.5 mg (Rivaroxaban)

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 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 this medicine together with aspirin 75-100mg once daily, or with aspirin 75-100mg once daily and clopidogrel 75mg. Treatment for at least 24 months is recommended. Because 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 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 evaluating the condition of each patient and considering the risk of bleeding relative to the risk of thrombotic events. During treatment with this medicine, patients who experience an acute thrombotic event or undergo a vascular procedure, and patients requiring dual antiplatelet therapy, should be evaluated for whether to continue this medicine at 2.5mg twice daily, based on the antiplatelet therapy and the type of thrombotic event or vascular procedure. The efficacy and safety of coadministration of this medicine with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Coadministration 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 dosing time. The daily dose should not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine INR values will be falsely elevated after taking this medicine, 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 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 take the vitamin K antagonist concomitantly until INR≥2.0. During the first 2 days after switching, 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, in patients receiving this medicine together with a vitamin K antagonist, INR should not be tested until 24 hours have elapsed 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 the next dose of this medicine would have been due. 3. Patients with renal impairment No dose adjustment is required in patients with mild renal impairment and creatinine clearance of 50-80 mL/min. Use of this medicine is not recommended in patients with severe renal impairment and 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 required 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 is significantly increased; therefore, this medicine should be administered with caution. 4. Patients with hepatic impairment Avoid administering this medicine to patients with liver disease associated with coagulopathy 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 administered 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 used to prevent or treat thrombosis by blocking blood clotting. However, during treatment, it is important to closely monitor for signs of bleeding, as the risk of bleeding may increase. If severe bleeding occurs, treatment should be discontinued immediately. This medication should not be administered to certain patients, for example, those who are allergic to it or those who are already bleeding, patients with severely impaired liver function, pregnant or nursing women, and patients with lactose intolerance. Additionally, caution is required in patients with a recent history of gastrointestinal ulcers or intracranial hemorrhage, or those with conditions that have a heightened risk of bleeding, and for those taking other anticoagulants. In patients with impaired kidney function or diseases with high bleeding risk, malignancies, and those taking certain medications, it should be given under careful medical judgment. This medication can cause various adverse reactions such as bleeding, anemia, gastrointestinal disturbances, skin rashes, and liver function abnormalities, so immediate consultation with healthcare professionals is essential if any abnormal symptoms appear. In particular, rapid evaluation and proper action are necessary if symptoms of bleeding or anemia occur. As this medication is metabolized and eliminated by the liver and kidneys, dose adjustment or the decision to administer it should be made carefully for patients with impaired liver or kidney function. This medication may interact with certain antifungals, antivirals, antibiotics, anticoagulants, and non-steroidal anti-inflammatory drugs, so inform your doctor or pharmacist if you are taking other medications. Pregnant or nursing women should not take this medication, and fertile women must use contraception during treatment. Elderly patients may have increased serum levels due to decreased kidney function, but adjustment of dosage is generally not required; however, there is increased risk of bleeding, so caution is advised. The safety and efficacy of this medication have not been established in children or adolescents under the age of 18 and are not recommended for use in this population. Overdose increases the risk of bleeding; if overdose is suspected, seek medical attention immediately. Patients may experience symptoms like fainting or drowsiness while taking this medication, requiring caution when driving or operating machinery. It may be necessary to discontinue this medication a certain period prior to surgery or invasive procedures and to resume it afterwards, considering the risk of bleeding and the condition of the patient. This medication is not recommended for patients with artificial heart valves or those requiring thrombolytic therapy for acute pulmonary embolism. If symptoms such as mucosal bleeding, skin rashes, severe headaches, dizziness, difficulty breathing, etc., occur, notify healthcare professionals immediately. It is crucial to be aware of all adverse reactions and precautions related to this medication and to receive regular medical evaluations and tests.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, 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, contusion, wound exudate, vascular pseudo-aneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminase, elevated bilirubin complexes, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, genitourinary bleeding, renal impairment, epistaxis, hemoptysis, pruritus, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions with systemic symptoms, eosinophilic pneumonia, anticoagulant-associated kidney disease, splenic rupture, arthralgia, unexplained bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, hematochezia, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine hemorrhage, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disorders, asthma, laryngitis, dysphagia, intestinal motility disorders, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, voiding disorders, kidney stones, bladder carcinoma, prostatic hyperplasia, influenza-like syndrome, drug hypersensitivity

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius to preserve the efficacy of the medication for a long period.

Appearance

Bright yellow, oval film-coated tablet

Package unit

56 tablets/box [(14 tablets/PTP packaging x 4)], 60 tablets/box [(10 tablets/PTP packaging x 6)], 100 tablets/box [(10 tablets/PTP packaging x 10)]