Jareliban (Rivaroxaban) 2.5mg Tablets

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 either aspirin 75-100mg once daily or aspirin 75-100mg once daily and clopidogrel 75mg. Treatment for at least 24 months is recommended. Since patients who have experienced acute coronary syndrome remain at risk of cardiovascular symptoms, extending the treatment duration 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 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 it should be taken with aspirin 75-100mg once daily. The duration of treatment with this medicine should be determined by regularly assessing each patient's condition, taking into account the risk of bleeding relative to 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 who require dual antiplatelet therapy, the decision 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 this medicine in combination with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Combination 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 with the recommended dose of 2.5mg at the next scheduled dose. 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 After taking this medicine, the INR value will be falsely elevated regardless of the dose. INR is not appropriate 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 when 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, and thereafter administer the dose based on INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, 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 In patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the next scheduled dose of the parenteral product (e.g., low-molecular-weight heparin), or when a continuously administered parenteral product (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 and creatinine clearance of 50-80 mL/min. Use of this medicine is not recommended in patients with severe renal impairment and 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 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, 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 and mixed with a liquid such as water or 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 properly positioned and flush the tube with water after administration.

This medication is used to prevent or treat blood clots by inhibiting coagulation. While taking this medication, bleeding may occur, so patients should vigilantly watch for signs of bleeding, such as nosebleeds, gum bleeding, hematuria, black stools, or sudden severe pain or swelling. If severe bleeding occurs, stop taking this medication immediately and consult with a healthcare professional. This medication should not be used in patients with certain liver diseases, severe bleeding, pregnant or breastfeeding women, and patients with lactose intolerance. It should be used cautiously in patients with impaired renal function or those with bleeding risk disorders, and caution is required when taking it with other drugs affecting blood coagulation, as this may increase bleeding risk. While taking this medication, regular blood tests to monitor bleeding and anemia are helpful. Women planning to become pregnant must consult a doctor before taking this medication and ensure effective contraception while on this drug. Elderly patients may have increased levels of this medication due to decreased kidney function; however, no separate dosage adjustment is needed, but the risk of bleeding may be increased. In case of overdose, the risk of bleeding may increase, and immediate medical attention is needed, as this medication is not removed by dialysis. This medication can interact with certain antifungals, antibiotics, anticoagulants, and non-steroidal anti-inflammatory drugs, so it is important to be cautious when used in combination. If undergoing surgery or invasive procedures, you must discuss the timing and method of stopping this medication with your healthcare provider. Caution is needed while driving or operating machinery, as this medication may cause drowsiness or dizziness. If severe skin rashes, mucosal ulcers, high fever, or severe bleeding symptoms occur, inform your healthcare provider immediately.

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

This medication must be stored in a tightly closed container to prevent air or moisture penetration, and it is safe to store in a temperature range of 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy and prevents deterioration.

Appearance

Bright yellow round film-coated tablets

Package unit

30 tablets/box [10 tablets/ptp*3]