Xarelto 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 with 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. Because 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 started 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 and should be started when 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 and considering the risk of bleeding relative to the risk of thrombotic events. During treatment with this medicine, for patients who develop an acute thrombotic event or undergo a vascular procedure, and for patients who require dual antiplatelet therapy, continued administration of this medicine at 2.5mg twice daily should be evaluated according to the antiplatelet regimen and the type of thrombotic event or vascular procedure. The efficacy and safety of concomitant administration of this medicine with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Concomitant administration 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 time. Do not double the daily dose to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine After taking this medicine, the INR value will be falsely elevated regardless of the dose. INR is not appropriate 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. Be aware that this medicine may affect INR elevation. Patients switching from this medicine to a vitamin K antagonist should take both medicines until the INR is ≥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 measured until 24 hours after taking this medicine. Once this medicine is discontinued, INR may be measured 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine In 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 a continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 4) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start 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 necessary in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance 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 with 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 concentrations of this medicine are significantly increased; 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 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 used to prevent or treat thrombosis by inhibiting blood coagulation. During treatment, bleeding may occur, hence symptoms or signs of bleeding should be closely monitored. If bleeding worsens, the medication should be stopped immediately, and medical consultation is required. This medication is contraindicated for patients with allergies to its components or those already experiencing significant bleeding. It should also not be administered to patients with severely impaired liver function, pregnant women, or breastfeeding women. Patients with lactose intolerance should also refrain from taking this medication. Recent history of gastrointestinal ulcers, brain hemorrhages, or surgeries of the brain or spine may increase the risk of bleeding, hence careful administration is required. Patients using other anticoagulants or certain antifungal agents should inform their doctor as it may increase the risk of bleeding. Patients with reduced kidney function may experience increased blood levels and risk of bleeding, requiring careful administration. Caution is also advised when taken with NSAIDs and platelet aggregation inhibitors due to increased bleeding risk. Adverse reactions during treatment may include bleeding, anemia, gastrointestinal discomfort, skin rash, etc. Severe symptoms should prompt immediate consultation with healthcare providers. During treatment, regular monitoring for bleeding symptoms or anemia is recommended. Due to the high risk of bleeding from overdose, prescribed dosages must be followed, and immediate medical attention is necessary if an overdose occurs. Prior to any surgical or invasive procedures, this medication may need to be discontinued, so inform healthcare providers in advance. Be careful as drowsiness or dizziness may occur when driving or operating machinery. Women who are pregnant or planning to become pregnant must use contraception while taking this medication, and nursing mothers should avoid its use. Elderly patients may have elevated drug concentrations due to reduced kidney function, but no specific dose adjustment is required; however, bleeding risk may be increased. Safety and efficacy have not been established in children or adolescents under 18 years, so it is not used in this population. Regular physician evaluations and tests are necessary during treatment to reduce the risk of bleeding.

Bleeding, anemia, thrombocytosis, tachycardia, ocular bleeding, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy decrease, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial bleeding, syncope, genitourinary bleeding, renal impairment, epistaxis, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, hives, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, fever, arthralgia, unspecified bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, pseudomembranous colitis, asthma, pulmonary edema, pleural effusion, flu-like symptoms, drug hypersensitivity reactions, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, bowel motility disorders, fractures, arthritis, joint disease, rhabdomyolysis, urinary tract infection, urination disorders, kidney stones, bladder carcinoma, prostatic hyperplasia, Stevens-Johnson syndrome

The medication should be kept in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature. This will ensure the medication's efficacy is preserved safely.

Appearance

Bright yellow round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP packaging x 3], 100 tablets/box [10 tablets/PTP packaging x 10]