Zyto 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) in patients who have experienced acute coronary syndrome accompanied by elevated cardiac biomarkers, when coadministered 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 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 started 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 discontinued as appropriate. 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 the condition of each individual patient, taking into account the risk of bleeding compared with the risk of thrombotic events. During treatment with this medicine, patients who experience an acute thrombotic event or undergo a vascular procedure, and patients who require dual antiplatelet therapy, should be assessed for whether to continue this medicine 2.5mg twice daily, 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 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 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 concomitantly until INR≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer a dose of the vitamin K antagonist 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 have elapsed after taking this medicine. Once this medicine is discontinued, INR testing may be performed after 24 hours have elapsed since 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 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. Administration 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 coadministered 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) has shown a significant increase in the blood concentration of this medicine; 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 cannot swallow tablets, immediately before use this medicine may be crushed and mixed with water or a beverage such as 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 stopping blood from clotting. However, the risk of bleeding may increase, so patients should be particularly cautious of bleeding symptoms. If severe bleeding occurs, the use of this medication should be stopped immediately. This drug should not be given to patients with allergies to the active ingredient or components, or to those who are already experiencing severe bleeding. It should also not be used by patients with severely impaired liver function, or by pregnant or breastfeeding women. Additionally, patients with lactose intolerance should not take this medication. Patients with recent gastrointestinal ulcers, a history of intracranial bleeding, or those who have undergone brain or spinal surgery also require caution. The risk of bleeding may increase if used in conjunction with other anticoagulants or specific antifungals, so consultation with a specialist is necessary. Patients with reduced kidney function or those with diseases that increase bleeding risk should use this medication with caution. When taken with non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors, the risk of bleeding may be further elevated. This medication may cause various side effects including bleeding, anemia, gastrointestinal disorders, and skin rashes, and in severe cases, it may threaten life. Elderly patients or those at high risk of bleeding should be especially careful, and it is important to regularly check for bleeding symptoms and conduct blood tests. Before surgery or invasive procedures, this medication should be discontinued for a certain period of time, and care should be taken as the risk of bleeding may increase during nerve anesthesia, leading to nerve damage. Pregnant women should not take this medication, and women who may become pregnant must use contraception during its use. In case of overdose, the risk of bleeding increases significantly, so immediate notification to medical personnel is necessary, and this medication is not removed by blood dialysis. Caution is needed while driving or operating machinery as drowsiness or dizziness may occur. Any unusual symptoms such as bleeding, skin rashes, or severe dizziness while taking this medication should be reported to a doctor immediately.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, systemic decrease in strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, pseudoaneurysm, transaminase elevation, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, renal dysfunction, epistaxis, hemoptysis, pruritus, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, fever, unexplained bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, deep vein thrombosis, arthralgia, Pseudomonas aeruginosa wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, elevated cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulceration, high fever, severe dysphagia, angina, severe uterine bleeding, postoperative bleeding, mucosal bleeding, anemic symptoms, hemorrhagic complications, hemorrhagic arthropathy, muscle bleeding, syncope, hematuria, menorrhagia

This medication should be stored tightly sealed in an airtight container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

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