Wireltol 2.5 mg (Rivaroxaban)

Adult dose

This medicine may be administered without regard to meals. 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. 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 2.5mg should be initiated 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 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 each patient's condition and 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, the decision on whether to continue 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 coadministration of this medicine with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Coadministration 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 dose. The daily dose should not be doubled to make up for a missed dose. 2. Switching therapy 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 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 the elevation of INR. Patients switching from this medicine 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; thereafter, administer a dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine concomitantly 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 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 blood levels 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 a liquid such as water or 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 correctly positioned, and flush the tube with water after administration.

This medication is an anticoagulant that prevents blood from clotting. It is important to be vigilant about possible bleeding symptoms during treatment. If serious bleeding occurs, immediately stop taking this medication and consult a healthcare professional. This medication should not be used by patients with specific bleeding disorders, severe liver disease, pregnant or nursing women, or anyone with an allergy to its components. Furthermore, patients who have recently suffered gastrointestinal ulcers, cerebral hemorrhage, or have undergone brain or spinal surgery, as well as those with a high risk of bleeding from malignancies, should avoid taking this medication. Caution is required when combining with other anticoagulants or certain antifungal drugs as it can increase the risk of bleeding, and you must consult a doctor. Patients with impaired kidney function or conditions that pose a high bleeding risk should be administered this medication with care, and the risk of bleeding may increase if other drugs affecting hemostasis are taken. During treatment, patients should carefully watch for signs of bleeding or anemia, and report immediately to a healthcare professional if sudden dizziness, pallor, or difficulty breathing occurs. This medication should be discontinued for a certain period before surgery or invasive procedures, and in the case of receiving regional anesthesia, special caution is necessary due to the risk of nerve damage from bleeding. During pregnancy, it may pose risks to the fetus, so it should be avoided, and women of childbearing potential must use contraception. Elderly patients may have a higher risk of bleeding, but no specific dose adjustment is necessary. This medication significantly increases the risk of bleeding in case of overdose, so prescribed dosages must be strictly followed, and if overdose is suspected, immediate consultation with a healthcare professional is necessary. Caution is advised when driving or operating machinery, as symptoms like drowsiness or fainting may occur.

• Hemorrhage
• anemia
• thrombocytosis
• tachycardia
• ocular hemorrhage
• gingival bleeding
• gastrointestinal bleeding
• gastric pain
• abdominal pain
• indigestion

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is best to store the medication at room temperature, avoiding extremes of cold or heat, ideally between 1 and 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

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