JAREX 2.5mg (Rivaroxaban (unmodified))

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 with aspirin 75-100mg once daily, or with aspirin 75-100mg and clopidogrel 75mg once daily. 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 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, and should be started when parenteral anticoagulant therapy has been discontinued normally. 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 with this medicine. The duration of treatment with this medicine should be determined by regularly assessing the individual patient's condition, taking into account the risk of bleeding versus thrombotic events. During treatment with this medicine, for patients who experience an acute thrombotic event, undergo a vascular procedure, or require dual antiplatelet therapy, the decision 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. 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 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 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 while 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 and a vitamin K antagonist concomitantly, 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 passed since 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 at the time 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 required in patients with mild renal impairment with creatinine clearance of 50-80 mL/min. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance of less than 15 mL/min, because 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 blood concentrations of this medicine were 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 a beverage 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 drug is an anticoagulant that prevents excessive blood coagulation. While taking this drug, signs of bleeding should be closely monitored. It should be used with caution in patients at high risk of bleeding, and if severe bleeding occurs, use should be discontinued immediately. This drug should not be administered to specific patients. For example, patients allergic to this drug or its components, those with existing severe bleeding, patients with severe liver disease, pregnant or nursing women, patients with lactose intolerance, those with a history of recent gastrointestinal ulcers or intracranial hemorrhage, patients with vascular abnormalities or cancers associated with a high risk of bleeding, and when coadministered with other anticoagulants. Patients with impaired kidney function or bleeding risks should be administered with caution, especially when combined with other drugs that may increase bleeding risk. Adverse reactions that may occur while taking this drug include bleeding, anemia, dyspepsia, headache, dizziness, skin rash, etc., and in severe cases, life-threatening bleeding or allergic reactions may occur. This drug should not be used during pregnancy as it may harm the fetus, and it should also be avoided while breastfeeding. Women of childbearing age must employ contraception while taking this drug. Elderly patients may experience increased serum concentration due to diminished renal function; however, dosage adjustments are generally not needed, although the risk of bleeding may increase. Safety and efficacy have not been established in children or adolescents under the age of 18; therefore, it is not recommended. In the case of overdose, the risk of bleeding is significantly elevated, and immediate consultation with healthcare personnel is necessary; emergency treatment may be required. This drug may interact with other medications, especially with certain antifungal agents, antibiotics, anticoagulants, nonsteroidal anti-inflammatory drugs (NSAIDs), and platelet inhibitors, so caution is needed when coadministering. If surgery or invasive procedures are planned, the intake of this drug may need to be discontinued for a certain period, and suddenly stopping this drug may increase the risk of thrombosis; therefore, physician’s instructions must be followed. During the course of taking this drug, if bleeding symptoms or adverse reactions appear, immediate notification to healthcare personnel is necessary, and caution should be exercised when driving or operating machinery.

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 loss, discomfort, localized edema, hepatic impairment, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound discharge, pseudoaneurysm, transaminase elevation, 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 hemorrhage, syncope, genitourinary bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug-induced reactions with systemic symptoms, eosinophilic pneumonia, anticoagulant-associated nephropathy, fever, unspecified hemorrhage, postoperative hematoma, myocardial infarction, hemorrhagic duodenal ulcer, bloody stool, melena, deep vein thrombosis, joint dislocation, arthralgia, Pseudomonas wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine hemorrhage, postoperative syncope, drowsiness

This drug 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 and 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablets

Package unit

56 tablets/box [(14/PTPX4)]