Myungin Rivaroxaban Tablet 2.5 mg

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 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 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 initiated 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 the condition of each individual patient and taking into account the risk of bleeding compared with the risk of thrombotic events. During treatment with this medicine, patients who experience an acute thrombotic event or undergo a vascular procedure, and patients who require dual antiplatelet therapy, should be assessed for whether to continue this medicine at 2.5mg twice daily, according to the antiplatelet therapy and the type of thrombotic event or vascular procedure. The efficacy and safety of this medicine in combination with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Combination 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 must not be doubled to make up for a missed dose. 2. Switching medicines 1) Switching from a vitamin K antagonist to this medicine INR values will be falsely elevated after taking this medicine, regardless of the dose. INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used. 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, 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 testing should not be performed until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR testing may be performed after 24 hours have elapsed since 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 preparation (e.g., low molecular weight heparin), or when discontinuing a continuously administered parenteral preparation (e.g., intravenous unfractionated heparin). 4) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start 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 in patients with severe renal impairment with a 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 the blood 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 unable to swallow tablets, immediately before use, this medicine may be crushed and mixed with water or a beverage such as applesauce for oral administration. 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 used to prevent or treat blood clots by inhibiting blood clotting. Monitoring for signs or symptoms of bleeding is necessary, as bleeding may occur during treatment. In case of serious bleeding, discontinue use immediately and consult a healthcare professional. This drug should not be used in patients with specific blood coagulation disorders, severely impaired liver function, pregnant or breastfeeding women, or patients with genetic issues such as lactose intolerance. Additionally, caution should be taken in patients who have recently experienced diseases or surgeries with a high risk of bleeding, or are taking other anticoagulants or specific antifungal drugs. Patients with renal dysfunction or diseases with a high risk of bleeding should use this drug carefully, especially when combined with other medications that may increase the risk of bleeding. During treatment, adverse reactions such as bleeding, anemia, or allergic reactions may occur, and patients should notify healthcare professionals immediately if symptoms arise. This drug may lead to serious side effects related to bleeding when combined with procedures that carry a high risk of bleeding, such as regional anesthesia or lumbar puncture, so careful management of the timing of administration around these procedures is essential. Patients should be cautious as symptoms such as fainting or drowsiness may occur while driving or operating machinery. In case of overdose, the risk of bleeding may significantly increase, so it is important to adhere strictly to the prescribed dosage and contact a healthcare institution if unusual symptoms occur. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, and appropriate contraception is necessary during treatment. Elderly patients may have increased drug concentration due to reduced renal function, though dosage adjustment is typically not required; however, the risk of bleeding may be higher. Safety in children and adolescents has not been established, so use is not recommended. As this drug may interact with several other medications, it is crucial to inform healthcare professionals of any other drugs being taken.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, systemic weakness and energy decrease, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment hemorrhage, bruising, wound exudate, vascular pseudoaneurysm, increased transaminases, increased bilirubin levels, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal dysfunction, epistaxis, 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, drug reaction with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, surgical site hemorrhage requiring reoperation, bleeding leading to hospitalization, major gastrointestinal bleeding, major intracranial bleeding, severe uterine hemorrhage, deep vein thrombosis, arthralgia, fever, unspecified bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, bowel motility disorders, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, dysuria, kidney stones, bladder carcinoma, prostatic hyperplasia, flu-like syndrome, drug hypersensitivity

Store this medication in a tightly closed container to protect it from air and moisture, ideally at a temperature between 1 and 30 degrees Celsius. This will help maintain the drug's efficacy over time.

Appearance

Bright yellow round film-coated tablet

Package unit

30 tablets/PTP [10 tablets/PTP × 3], 100 tablets/PTP [10 tablets/PTP × 10]