Jarelson Tablet 2.5 mg (Rivaroxaban)

Adult dose

This drug 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 with elevated cardiac biomarkers, when administered in combination with aspirin or with aspirin and clopidogrel The recommended dose of this drug 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 drug. Treatment for at least 24 months is recommended. Since patients who have experienced acute coronary syndrome remain at risk of cardiovascular symptoms, extending the treatment period may be beneficial. Treatment with this drug at 2.5mg should be started as soon as possible after the acute coronary syndrome event has stabilized (including revascularization). Treatment may be initiated as early as 24 hours after hospitalization, and should be started once parenteral anticoagulant therapy has been appropriately discontinued. 2) Coronary artery disease (CAD) or peripheral artery disease (PAD) The recommended dose of this drug is 2.5mg twice daily, and aspirin 75-100mg once daily should be taken together with this drug. The duration of treatment with this drug should be determined by regularly assessing the condition of each individual patient and considering the risk of bleeding compared with the risk of thrombotic events. During treatment with this drug, in patients who experience an acute thrombotic event or undergo a vascular procedure, and in patients who require dual antiplatelet therapy, the decision whether to continue treatment with this drug 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 drug with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Concomitant use of this drug with dual antiplatelet therapy has not been studied in patients with coronary artery disease or peripheral artery disease. 3) If you miss a dose of this drug If you miss a dose of this drug, continue taking the recommended dose of 2.5mg at the next scheduled dosing 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 drug After taking this drug, the INR value will be falsely elevated, regardless of the dose. INR is not suitable for measuring the anticoagulant activity of this drug and should not be used for this purpose. 2) Switching from this drug to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this drug to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this drug may affect the increase in INR. Patients switching from this drug to a vitamin K antagonist should receive 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. On the other hand, in patients receiving this drug together with a vitamin K antagonist, INR should not be tested until 24 hours have elapsed after taking this drug. Once this drug is discontinued, INR may be tested 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this drug In patients receiving a parenteral anticoagulant, start this drug 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 drug to a parenteral anticoagulant Discontinue this drug and start the parenteral anticoagulant at the time of the next scheduled dose of this drug. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Since there is no clinical experience in patients with severe renal impairment with creatinine clearance less than 15 mL/min, administration of this drug is not recommended. 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 the blood concentration of this drug increased significantly; therefore, administer this drug with caution. 4. Patients with hepatic impairment Avoid administering this drug 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 drug and an increased risk of bleeding may occur in these patients. 5. For patients who are unable to swallow tablets, this drug may be crushed immediately before use, mixed with a liquid such as water or applesauce, and administered orally. This drug may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this drug through a gastrointestinal tube, confirm that the tube is properly positioned and flush the tube with water after administration.

This medication acts to prevent blood coagulation in the bloodstream and is mainly used for the prevention and treatment of thrombosis. During the intake of this medication, bleeding may occur, so signs or symptoms of bleeding must be carefully monitored. If severe bleeding occurs, discontinue the medication immediately and consult a healthcare professional. This medication is contraindicated for individuals with certain diseases or conditions. For example, individuals who are allergic to this medication, pregnant, or nursing should not take it. Moreover, those with severe liver disease or clotting disorders, or who have recently had intracranial bleeding or gastrointestinal bleeding, should not use it. The risk of bleeding can significantly increase if this medication is used in combination with other anticoagulants, so it is advised to avoid concurrent use with other anticoagulants. Patients with impaired kidney function or diseases with a high bleeding risk, as well as those taking non-steroidal anti-inflammatory drugs (NSAIDs) or antiplatelet agents, should be particularly cautious when taking this medication. Elderly patients may have higher blood concentrations of this medication, although generally dosage adjustments are not necessary. Pregnant women should avoid using this medication, and women who might become pregnant must use contraception while taking it. This medication may interact with certain antifungal or antiviral agents; hence, if other medications are being taken, it is essential to inform a healthcare professional. If bleeding is suspected, blood tests should be conducted to confirm the presence and extent of bleeding, and appropriate treatment should be given if necessary. Before any surgery or invasive procedures, this medication may need to be discontinued for a certain period, so consulting with healthcare professionals is crucial. This medication may affect driving or operating machinery; therefore, caution should be exercised if symptoms such as dizziness or drowsiness occur. In case of overdose, the risk of bleeding may increase; hence, adhere strictly to the recommended dosage and inform healthcare professionals immediately if abnormal symptoms appear.

Bleeding, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, indigestion, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general weakness and energy loss, discomfort, local edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial and cerebral hemorrhage, syncope, genitourinary bleeding, hematuria, menorrhagia, renal impairment, epistaxis, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions with systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, bleeding at the surgical site requiring reoperation, bleeding necessitating hospitalization, major gastrointestinal bleeding, major intracranial bleeding, deep vein thrombosis, arthralgia, Pseudomonas wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, elevated cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, expectoration disease, asthma, laryngitis, dysphagia, bowel motility disorder, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urination disorders, kidney stones, bladder carcinoma, prostatic hyperplasia, flu-like syndrome, drug hypersensitivity reaction

This medication may be sensitive to air and moisture; thus, it should be stored in a tightly sealed container. The optimal storage temperature is between 1 to 30 degrees Celsius, which helps maintain the medication's efficacy.

Appearance

Bright yellow, round film-coated tablet

Package unit

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