Rivaroxaban Tablet 2.5 mg (Rivaroxaban)

Adult dose

This medicine may be taken 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 once daily and clopidogrel 75mg. Treatment for at least 24 months is recommended. Since 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 initiated as early as 24 hours after hospitalization, 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 2.5mg twice daily, and aspirin 75-100mg should be taken once daily with this medicine. The duration of treatment with this medicine 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 medicine, for patients who experience an acute thrombotic event or undergo a vascular procedure, and for patients who require dual antiplatelet therapy, the decision to continue this medicine at 2.5mg twice daily should be evaluated 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. 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. 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 medicine The INR value 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 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 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 testing. 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 has been discontinued, INR testing may be performed 24 hours after 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 agent (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 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 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, 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 the blood concentration of this medicine is 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 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 correctly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat the formation of clots by stopping the blood from clotting. During treatment, signs of bleeding should be closely monitored. The risk of bleeding may increase, so if bleeding worsens, you should stop taking it immediately. This medication should not be administered to patients with certain diseases or conditions. For instance, it should not be used by patients who are allergic to any component of this drug, have severe bleeding, have serious liver dysfunction, are pregnant or breastfeeding, or have lactose intolerance. Precautions are also needed for patients with a history of gastrointestinal ulcers or intracranial bleeding, or vascular abnormalities and when used in combination with other anticoagulants or certain antifungal drugs. Patients with reduced kidney function or those with conditions that increase the risk of bleeding, as well as patients taking medications that affect hemostasis like non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors, should be administered this drug cautiously. Various adverse reactions can occur, including bleeding, anemia, gastrointestinal symptoms, skin rashes, so if symptoms arise, consult a doctor immediately. During pregnancy, the potential risk to the fetus means it should be avoided, and breastfeeding women should also either stop nursing or take this drug after stopping breast feeding. In the elderly, the blood concentration may increase due to reduced kidney function, but special dosage adjustments are not necessary; however, the risk of bleeding may increase. Safety in children and adolescents under 18 years has not been established, so it is not recommended. In the case of overdose, there is an increased risk of bleeding, so prompt medical evaluation and treatment are necessary, and this medication is not removed by hemodialysis. Drowsiness or fainting may occur when driving or operating machinery, so caution is advised. This drug is influenced by certain liver enzymes and drug transporters, so the risk of bleeding may increase when used with some antifungals, antivirals, antibiotics, anticoagulants, and anti-inflammatory medications; therefore, consult a doctor before use. Before any surgery or invasive procedure, this medication should be discontinued for a certain period, and after discontinuation, the risk of bleeding and treatment benefits should be carefully evaluated. Sudden discontinuation of this medication can increase the risk of clot formation, so it should be appropriately managed according to a doctor's instructions.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound discharge, vascular pseudoaneurysm, transaminase elevation, increased serum bilirubin, increased alkaline phosphatase, elevated LDH, increased lipase, elevated 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 reactions associated with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, surgical site bleeding requiring reoperation, bleeding necessitating hospitalization, major gastrointestinal bleeding, significant intracranial bleeding, severe uterine hemorrhage, deep vein thrombosis, arthralgia, fever, bleeding of unspecified origin, postoperative hematoma, myocardial infarction, hemorrhagic duodenal ulcer, melena, black stool, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, cardiomyopathy, elevated cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, pseudomembranous 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, influenza-like syndrome, drug hypersensitivity reactions

This medication should be stored in a tightly closed container to protect it from air and moisture at a temperature between 1 and 30 degrees Celsius. Therefore, to maintain the drug's effectiveness, avoid exposure to direct sunlight or high temperatures and humidity, and store it at an appropriate temperature.

Appearance

Yellow round film-coated tablets

Package unit

60 tablets/box [(10 tablets/PTP) X 6]