Rivaroxaban 2.5 mg (Rivaroxaban)

Adult dose

This medicine may be administered with or without food. 1. Adults 1) Reducing 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 coadministered 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 symptoms, extending the duration of treatment may be beneficial. Treatment with this medicine at 2.5mg should be initiated as soon as possible after stabilization of the acute coronary syndrome event (including revascularization). Treatment may be initiated as early as 24 hours after hospitalization and should be started when parenteral anticoagulation 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 the individual patient's condition and considering 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, whether to continue this medicine at 2.5mg twice daily should be assessed according to the antiplatelet therapy and the type of thrombotic event or vascular procedure. 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. Do not take twice the recommended daily dose to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine The INR value will be falsely elevated after taking this medicine, 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 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; thereafter, administer the vitamin K antagonist dose according to INR testing. 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 In patients receiving a parenteral anticoagulant, initiate this medicine 0~2 hours before the next scheduled dose of the parenteral agent (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 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 because there is no clinical experience in patients with severe renal impairment with a creatinine clearance of less than 15 mL/min. 1) Reducing 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 coadministered 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 plasma concentration of this medicine increased significantly; 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 a liquid such as water or 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 prevents clot formation by inhibiting blood clotting. During treatment, be observant for signs of bleeding such as nosebleeds, gum bleeding, and easy bruising. If severe bleeding occurs, discontinue use immediately and consult a doctor. This medication should not be used in patients with certain liver diseases, pregnant or breastfeeding women, and patients with lactose intolerance. It is also contraindicated in individuals who have had recent bleeding or those at high risk of bleeding. Patients with impaired kidney function or diseases associated with a high risk of bleeding should use this drug cautiously. Special care is needed when taken with other medications that may increase bleeding risk. During treatment, be vigilant for not only bleeding symptoms but also anemia symptoms, and check blood levels if necessary. If surgery or invasive procedures are planned, consult a doctor to determine when and how to stop taking this medication. Women who are pregnant or plan to become pregnant should consult a physician and use contraception while taking this medication. Elderly patients may have higher plasma concentrations of this drug, increasing the risk of bleeding, so caution is warranted during administration. This drug may increase the bleeding risk when taken concurrently with certain antifungals or antivirals, so disclose any additional medications to the doctor. In case of overdose, the risk of bleeding may increase, thus the prescribed dosage must be adhered to, and if unusual symptoms arise, contact healthcare professionals immediately. Be cautious while driving or operating machinery as drowsiness or fainting may occur.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general decrease in strength and energy, discomfort, localized edema, hepatic impairment, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusions, wound exudate, vascular pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased enzyme levels, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, nosebleeds, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions associated with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, tarry stools, myocardial infarction, arthralgia, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, mucosal colitis, asthma, pulmonary edema, pleural effusion, postoperative syncope, drowsiness

Store this medication in a tightly closed container to prevent exposure to air and moisture, at room temperature between 1°C and 30°C. This storage method will help maintain its effect over time.

Appearance

Yellow, double-sided convex round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP*3]