Rivaroxaban 2.5 mg

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. Since patients who have experienced acute coronary syndrome remain at risk of cardiovascular events, extending the treatment duration may be beneficial. Treatment with this medicine 2.5mg should be started 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 each patient's condition 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 who require dual antiplatelet therapy, continued administration of this medicine 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 administering this medicine in combination with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Concomitant administration of this medicine with dual antiplatelet therapy has not been studied in patients with coronary artery disease or peripheral artery disease. 3) If you miss a dose of this medicine If you miss a dose of 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 INR values 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 while switching to another anticoagulant. Note that this medicine may affect INR elevation. 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 the dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, INR testing must 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 discontinuing a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 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 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 blood 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 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 properly positioned, and flush the tube with water after administration.

This drug is used to prevent or treat the formation of blood clots by preventing blood from clotting. While taking this medication, you should closely monitor for signs of bleeding, and exercise particular caution if the risk of bleeding rises. If severe bleeding occurs, you must immediately stop taking this medication and seek appropriate treatment as directed by a healthcare professional. This medication should not be administered to certain patients, such as those with allergies to this drug or its ingredients, those with serious bleeding, patients with severe liver disease, pregnant or nursing women, and those with lactose intolerance. Additionally, it should be avoided in patients with conditions that increase the risk of bleeding or when combined with other anticoagulants. Patients with impaired renal function or diseases that may increase bleeding risk should use this medication cautiously, considering the balance between bleeding risk and therapeutic benefit. This drug can also produce various side effects, including bleeding, anemia, gastrointestinal discomfort, liver function disturbances, and allergic reactions, so inform a healthcare provider if any abnormal symptoms occur. In particular, if you experience severe skin rashes or mucosal ulcers, discontinue use and seek medical advice. This drug can increase the risk of bleeding during procedures such as neuraxial anesthesia or lumbar puncture; therefore, consult with healthcare professionals if such procedures are planned. It is prohibited during pregnancy due to potential risks to the fetus, and women who may become pregnant should use contraception while taking this medication. Elderly patients may experience increased blood levels due to decreased renal function, leading to a higher risk of bleeding; however, dose adjustments are generally not necessary. In cases of overdose, the risk for bleeding may increase, so immediate medical attention is needed, as the drug cannot be removed via dialysis. This medication can interact with certain antifungals, antibiotics, anticoagulants, and non-steroidal anti-inflammatory drugs, increasing the risk of bleeding; hence, it is crucial to inform healthcare providers of all medications being taken. This medication may affect driving or operating machinery; caution is advised in the presence of dizziness or drowsiness. Regular blood tests and clinical evaluations are important during treatment to monitor for bleeding.

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

This medication must be stored in a tightly closed container to avoid exposure to air or moisture. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature. This will help preserve the efficacy and safety of the medication over time.

Appearance

Bright yellow round film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP × 3], 100 tablets/box [10 tablets/PTP × 10]