Rivacor Tablets 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 2.5 mg twice daily. Patients should take aspirin 75-100 mg once daily or aspirin 75-100 mg once daily and clopidogrel 75 mg together with this medicine. Treatment for at least 24 months is recommended. Because 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 2.5 mg should be started 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 once parenteral anticoagulant therapy has been appropriately discontinued. 2) Coronary artery disease (CAD) or peripheral artery disease (PAD) The recommended dose of this medicine is 2.5 mg twice daily, and aspirin 75-100 mg 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 patient, taking into account the risk of bleeding compared with the risk of thrombotic events. During treatment with this medicine, in patients who experience an acute thrombotic event or undergo a vascular procedure, and in patients requiring dual antiplatelet therapy, whether to continue this medicine at 2.5 mg twice daily should be assessed according to the antiplatelet regimen and the type of thrombotic event or vascular procedure. The efficacy and safety of concomitant use of this medicine 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 miss a dose of this medicine If you miss a dose, continue taking the recommended dose of 2.5 mg 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 suitable 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 INR elevation. Patients switching from this medicine to a vitamin K antagonist should take the vitamin K antagonist concomitantly until the INR is ≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer a dose based on INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, 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 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. There is no clinical experience in patients with severe renal impairment and creatinine clearance below 15 mL/min; therefore, use of this medicine 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 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, 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 are 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 works by interfering with the blood coagulation process to prevent or treat the formation of clots. During treatment, there is a risk of bleeding, so signs or symptoms of bleeding should be carefully monitored. Particularly, if severe bleeding occurs, the use of this medication should be stopped immediately and the healthcare provider should be consulted. This drug should not be administered to patients with certain diseases or conditions, such as severe bleeding, significantly impaired liver function, pregnant or nursing women, or patients with lactose intolerance. It should be administered with extra caution in patients with impaired kidney function or those at high risk of bleeding, as there may be an increased risk of bleeding when taken with other anticoagulants or drugs that increase bleeding risk. During treatment, symptoms of bleeding as well as symptoms of anemia should be monitored, and if any abnormal symptoms appear, healthcare providers must be informed immediately. If surgery or invasive procedures are planned, it may be necessary to stop this medication in advance, so consultation with healthcare providers is important. Additionally, this drug should not be taken during pregnancy, and women who may become pregnant must use contraception while taking it. In elderly patients, blood drug concentrations may increase, but generally, dosage adjustment is not necessary; however, caution is advised as the risk of bleeding may increase. In cases of overdose, the risk of bleeding is increased, so immediate medical attention is required, and because this medication cannot be removed by dialysis, special treatment may be needed. There are medications that interact with this drug, so patients taking other medications should inform their healthcare provider, especially when used in combination with certain antifungals, antivirals, anticoagulants, non-steroidal anti-inflammatory drugs, or antiplatelet agents, as the risk of bleeding may be increased. Caution is advised when driving or operating machinery if symptoms such as drowsiness or fainting occur.

Bleeding, 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, local edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusions, wound discharge, vascular pseudoaneurysm, increased transaminases, 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, intracranial and intracerebral hemorrhage, syncope, urogenital bleeding, renal impairment, 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, eosinophilia, drug reaction with systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, myocardial infarction, arthralgia, deep vein thrombosis, joint dislocation, Pseudomonas wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulceration due to agranulocytosis, high fever, severe dysphagia, angina, postoperative bleeding, thrombosis, deep vein thrombosis, facial flushing, syncope, drowsiness

This medication should be stored in a tightly closed container to protect it from exposure to air or moisture, and it is best to keep it in a cool room at a temperature between 1 to 30 degrees Celsius.

Appearance

Yellow, round, biconvex film-coated tablet

Package unit

PTP - 30 tablets/box [10 tablets/PTP*3], PTP - 100 tablets/box [10 tablets/PTP*10], Bottle - 100 tablets/bottle