Zarokut Tablet 2.5 mg (Rivaroxaban)

Adult dose

This medicine may be administered regardless of meals. 1. Adults 1) Reduction in the incidence of atherothrombotic events (death due to cardiovascular causes, myocardial infarction) when coadministered with aspirin or with aspirin and clopidogrel in patients who have experienced acute coronary syndrome accompanied by elevated cardiac biomarkers 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 symptoms persists in patients who have experienced acute coronary syndrome, extending the duration of treatment may be beneficial. Treatment with this medicine 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, taken together with aspirin 75-100mg once daily. 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 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 requiring dual antiplatelet therapy, continued administration of this medicine 2.5mg twice daily should be evaluated according to the antiplatelet regimen 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 dosing time. Do not take twice the recommended 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 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 must 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, then administer a dose based on 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 is discontinued, INR testing may be performed 24 hours after 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 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 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 50-80 mL/min. Use of this medicine is not recommended in patients with severe renal impairment and creatinine clearance 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) when coadministered with aspirin or with aspirin and clopidogrel in patients who have experienced acute coronary syndrome accompanied by elevated cardiac biomarkers 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 plasma concentrations of this medicine are significantly increased; therefore, administer this medicine 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 cannot swallow tablets, immediately before use, this medicine may be crushed, mixed with a drink such as water or applesauce, and administered orally. This medicine may also be crushed and administered with a small amount of water through an enteral feeding tube. Before administering this medicine through an enteral feeding tube, verify that the tube is correctly positioned, and flush the tube with water after administration.

This medication is an anticoagulant that prevents blood clotting. During treatment, bleeding may occur, so signs of bleeding must be monitored carefully. If severe bleeding occurs, discontinue use immediately and consult a physician. This drug should not be administered to patients with certain diseases or conditions, such as those already experiencing bleeding, patients with severely impaired liver function, pregnant or breastfeeding women, and those with lactose intolerance. Care should also be taken in patients with diseases that increase the risk of bleeding or those taking other anticoagulants. Caution is advised when administering to patients with impaired renal function or other diseases that increase bleeding risk, especially when taken with medications that elevate bleeding risk. During treatment, various adverse reactions such as bleeding, anemia, skin rash, liver function anomalies, etc., can occur, so symptoms should be reported to medical personnel immediately. Use is not recommended or requires caution in elderly individuals or children and adolescents. Overdose may increase the risk of bleeding, requiring careful monitoring and treatment if necessary. Additionally, this drug may affect driving or operation of machinery, so caution should be exercised if symptoms occur. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should engage in contraception during treatment. This medication can interact with several drugs, so if other medications are being taken, consultation with a physician or pharmacist is essential. It may also be necessary to discontinue this medication in advance if surgery or invasive procedures are planned. Sudden discontinuation of this medication can increase the risk of thrombosis, so consult with medical personnel when stopping the medication.

• Bleeding
• anemia
• thrombocytosis
• tachycardia
• ocular bleeding
• gingival bleeding
• gastrointestinal bleeding
• stomachache
• abdominal pain
• dyspepsia

Store this medication in a tightly sealed container to prevent exposure to air or moisture, at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness and prevent deterioration.

Appearance

Yellow, bilaterally convex round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP*3)]