JaRel Q Tablet 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 aspirin 75-100mg once daily and clopidogrel 75mg. Treatment for at least 24 months is recommended. Because the risk of cardiovascular events 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 appropriately discontinued. 2) Coronary artery disease (CAD) or peripheral artery disease (PAD) The recommended dose of this medicine is 2.5mg twice daily, taken together with aspirin 75-100mg once daily. The duration of treatment with this medicine should be determined by regularly assessing the condition of each individual patient, taking into consideration the risk of bleeding compared with the risk of thrombotic events. During treatment with this medicine, for patients who experience an acute thrombotic event or undergo a vascular procedure and 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 this medicine administered 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 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 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. 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 dose of the vitamin K antagonist according to INR test results. However, in patients receiving this medicine together with a vitamin K antagonist, INR testing should not be performed until 24 hours after taking this medicine. Once this medicine is 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 time of the next scheduled parenteral dose (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 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 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 increased significantly; therefore, administer this medicine 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 are unable to swallow the tablet, 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 an anticoagulant that prevents blood from clotting to inhibit thrombus formation. During treatment, it is essential to closely monitor for signs of bleeding, particularly in individuals with a high risk of bleeding. If severe bleeding occurs, the use of this medication should be stopped immediately, and medical advice should be sought. This medication should not be administered to patients with certain liver diseases, significant bleeding, pregnant or nursing women, or those with lactose intolerance. Furthermore, patients with recent histories of gastrointestinal ulcers, cerebral hemorrhages, or specific vascular abnormalities should also avoid this medication. When used in combination with other anticoagulants or certain antifungal agents, the risk of bleeding may increase, so consultation with healthcare professionals is crucial. Caution is advised for patients with renal impairment or those with diseases that pose a high risk of bleeding, especially when taken alongside other medications that may elevate bleeding risk. This medication can cause side effects related to bleeding and anemia, so any unusual symptoms should be reported to a healthcare provider immediately. In case of severe bleeding, appropriate treatment measures such as physical compression, hemostatic procedures, and transfusion may be necessary. Elderly individuals may experience elevated blood levels; however, dosage adjustment is generally not needed. Pregnant or nursing women should not take this medication, and women of childbearing potential should implement effective contraception during use. Regular blood testing and clinical evaluations are required to reduce bleeding risks during treatment. Additionally, it is important to inform healthcare providers prior to undergoing surgery or invasive procedures as the medication may need to be discontinued for a specified period. In cases of overdose, the risk of bleeding increases, necessitating immediate medical attention.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival hemorrhage, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general weakness and fatigue, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased enzyme levels, increased bilirubin conjugate, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, hematuria, excessive menstrual bleeding, renal dysfunction, nasal bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, bile stasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions associated with systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, surgical site bleeding requiring reoperation, hemorrhagic duodenal ulcer, melena, dark stools, myocardial infarction, arthralgia, unspecified bleeding, postoperative hematoma, deep vein thrombosis, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine bleeding, surgical site bleeding, cardiac ischemic symptoms, compartment syndrome, renal failure, agranulocytosis, mucosal ulcer, high fever, severe dysphagia, angina, skin rash, hypersensitivity, neurological symptoms, syncope, drowsiness

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. Furthermore, it should be kept away from excessively hot or cold environments, ideally at room temperature between 1°C and 30°C.

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]