Rivaroxaban 2.5 mg Capsules

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 with 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. Because 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 hospital admission, 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 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, taking into account the risk of bleeding relative to 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, whether to continue treatment with 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 in combination with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. The 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 take twice the recommended daily dose to make up for a missed dose. 2. Switching medicines 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 levels. Patients switching from this medicine to a vitamin K antagonist should receive both medicines 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 should not be tested until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR may be tested after 24 hours have elapsed since the last dose. 3) Switching from a parenteral anticoagulant to this medicine For patients receiving a parenteral anticoagulant, initiate 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 initiate 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 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 below 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 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 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.

This medication is used to prevent or treat blood clots by inhibiting coagulation. While taking this medicine, bleeding may occur; therefore, it is crucial to monitor carefully for any signs or symptoms of bleeding. If severe bleeding occurs, the use of this medication should be discontinued immediately, and healthcare professionals should be consulted. This medication should not be used in patients with certain liver diseases, those at high risk for bleeding, pregnant or breastfeeding women, and patients with specific genetic issues such as lactose intolerance. Patients with impaired kidney function or bleeding disorders should use this medication cautiously, weighing the risks of bleeding against the benefits of treatment. Caution is warranted when taking this medication with other anticoagulants or specific antifungal agents as the risk of bleeding may increase. While taking this medication, both signs of bleeding and symptoms of anemia should be closely monitored, and any suspicion of bleeding should be reported to healthcare professionals immediately. In cases of scheduled surgery or invasive procedures, this medication should be discontinued for a certain period and resumed post-procedure with consideration of the bleeding risk. This medication is contraindicated during pregnancy, and women of childbearing potential must use contraception while taking it. Elderly patients may have increased blood concentration due to decreased kidney function, thus increasing the risk of bleeding, but generally, dosage adjustments are not necessary. In cases of overdose, the risk of bleeding may significantly increase, so it is vital to adhere strictly to the prescribed dosage, and any suspicion of overdose should be discussed with healthcare professionals immediately. When driving or operating machinery, caution is necessary due to potential side effects such as drowsiness or fainting associated with this medication. If severe skin rashes or allergic reactions occur while taking this medication, it should be stopped immediately, and healthcare professionals should be informed. This medication may affect the results of blood coagulation tests, so patients should inform healthcare providers about its use during testing.

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 fatigue, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, pseudoaneurysm, increased transaminases, elevated bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transfer enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, genitourinary bleeding, hematuria, menorrhagia, renal impairment, epistaxis, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, 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 renal pathology, surgical site bleeding requiring reoperation, unexplained bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, myocardial infarction, arthralgia, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membrane colitis, asthma, pulmonary edema, pleural effusion, severe uterine bleeding, syncope, drowsiness

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius to preserve the effectiveness and safety of the drug for a prolonged period.

Appearance

White or almost white granules in a hard gelatin capsule, yellow in color

Package unit

60 capsules/box [(10 capsules/PTP) x 6]