Hanwha Rivaroxaban Tablet 2.5 mg

Adult dose

This medicine may be administered 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 aspirin 75-100mg once daily, or with aspirin 75-100mg once daily and clopidogrel 75mg. Treatment for at least 24 months is recommended. Because 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 started as early as 24 hours after hospitalization, once parenteral anticoagulant therapy has been routinely discontinued. 2) Coronary artery disease (CAD) or peripheral artery disease (PAD) The recommended dose of this medicine is 2.5mg twice daily, taken 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, 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. 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 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 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 increase in INR. Patients switching from this medicine to a vitamin K antagonist should take the vitamin K antagonist together with this medicine 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, patients taking this medicine together with a vitamin K antagonist should not undergo INR testing until 24 hours have passed 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 agent (e.g., low molecular weight heparin), or when the 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 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 because 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 concentrations of this medicine increased significantly; 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 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 medication is used to prevent or treat blood clots by inhibiting blood coagulation. However, similar to other anticoagulants, there is a risk of bleeding, so signs of bleeding must be observed carefully. If serious bleeding occurs, administration must be stopped immediately, and specialized medical treatment may be necessary. Patients with a hypersensitivity to this medication, patients with existing severe bleeding, those with severely impaired liver function, and women who are pregnant or breastfeeding should not use this medication. Additionally, it should be avoided in patients with a high risk of bleeding, such as recent gastrointestinal ulcers, intracranial hemorrhage, or brain surgery. The bleeding risk may be increased when combined with other anticoagulants or certain antifungal medications, so instructions from a doctor must be followed. Patients with impaired kidney function or diseases with a high risk of bleeding should be administered this medication with caution, and more careful observation of bleeding signs is necessary. The medication may cause various side effects, including bleeding, anemia, gastrointestinal disturbances, and skin rashes, and any unusual symptoms should be reported to healthcare personnel immediately. Especially elderly patients or those at high risk of bleeding should pay more attention to any bleeding symptoms. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing potential must ensure contraception while on this medication. If surgery or invasive procedures are planned, administration of the medication should be stopped prior to the procedure and resumed as per the doctor's judgment post-procedure. Overdosage increases the risk of bleeding, so caution is required, and specialized treatment is needed in emergencies. Symptoms such as drowsiness or fainting may occur while driving or operating machinery, so caution is advised. There are many medications that interact with this medication, so if other medications are being taken, medical personnel must be consulted.

Bleeding, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized decrease in strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound secretion, vascular pseudoaneurysm, transaminase increase, blood bilirubin increase, alkaline phosphatase increase, LDH increase, lipase increase, amylase increase, transferase increase, conjugated bilirubin increase, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylaxis, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions with systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, myocardial infarction, arthralgia, deep vein thrombosis, facial flushing, congestive heart failure, urinary tract infection, membrane colitis, asthma, pulmonary edema, pleural effusion, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, intestinal motility disorder, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urinary disorders, kidney stones, bladder carcinoma, prostatic hyperplasia, influenza-like symptoms, drug hypersensitivity reactions, Stevens-Johnson syndrome, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, facial flushing, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C to preserve the effectiveness of the medication.

Appearance

Bright yellow, round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP packaging x 3], 100 tablets/box [10 tablets/PTP packaging x 10]