Rivaroxaban Tablets 2.5 mg (Rivaroxaban)

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 symptoms, extending the treatment period may be beneficial. Treatment with this medicine at a dose of 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 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 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 relative to 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 have the need to continue this medicine at a dose of 2.5mg twice daily evaluated according to the antiplatelet therapy and the type of thrombotic event or vascular procedure. The efficacy and safety of concomitant use of this medicine with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Concomitant 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 taking 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 while switching to another anticoagulant. Be aware that this medicine may affect the elevation of 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 the switch, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist according to INR test results. However, in patients receiving this medicine together with a vitamin K antagonist, INR should not be tested until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR may be tested 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 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 required 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, 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 with elevated cardiac biomarkers, when administered in combination with aspirin or with aspirin and clopidogrel No dose adjustment is required 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 were 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, this medicine may be crushed immediately before use, mixed with a beverage such as water or applesauce, and taken orally. This medicine may also be crushed and administered with a small amount of water through a feeding tube. Before administering this medicine through a feeding tube, confirm that the tube is properly positioned, and flush the tube with water after administration.

This medication prevents clotting of the blood and inhibits the formation of thrombus. During treatment, bleeding may occur, so you must observe for any signs of bleeding carefully. If severe bleeding occurs, immediately stop taking the medication and seek treatment as directed by a doctor. This medicine should not be given to certain patients. For example, those who are allergic to any components of this drug, patients with severe bleeding, those with significantly reduced liver function, women who are pregnant or breastfeeding, and patients with lactose intolerance should not take this medication. Furthermore, patients with recent gastrointestinal ulcers or a history of brain hemorrhage or those with diseases that increase the risk of bleeding should also avoid this medication. Patients with impaired renal function or those with diseases that increase the risk of bleeding should use this drug cautiously. Also, care is needed when taking medications that increase bleeding risk, such as non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors. During treatment with this drug, bleeding or anemia symptoms may occur, so regular blood tests to monitor the condition are advisable. If bleeding is suspected, notify medical personnel immediately, and stop the medication if necessary and receive appropriate treatment. Particularly in elderly patients, those with impaired renal function, or patients at high risk of bleeding, careful attention is required as the likelihood of bleeding may increase while taking this medication. Co-administration with certain antifungal or antiviral medications may increase serum concentration and the risk of bleeding, so patients taking such medicines should consult their doctor. Women who are pregnant or breastfeeding should not use this medication, and women planning to conceive should consult their doctor before taking it and ensure appropriate contraception. This medication may cause side effects such as drowsiness or fainting that can impact driving or operating machinery, so such activities should be avoided when these symptoms are present. In cases of overdose, the risk of bleeding may significantly increase, so the prescribed dosage must be strictly adhered to, and in case of overdose, immediate medical attention should be sought.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, overall decrease in strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reaction, allergic dermatitis, post-treatment bleeding, bruising, discharge from wound site, pseudovasculitis, increase in transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugate, limb pain, hemorrhagic arthropathy, muscular hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug response associated with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, fever, unexplained bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, black stools, deep vein thrombosis, joint dislocation, arthralgia, Pseudomonas aeruginosa wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membrane colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulcer, high fever, severe dysphagia, angina pectoris, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, black stools, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, gastrointestinal motility disorder, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urination disorders, renal stones, bladder carcinoma, prostatic hyperplasia, flu-like syndrome, drug hypersensitivity reaction, Stevens-Johnson syndrome

This medication should be stored in a tightly sealed container to prevent air and moisture from entering and is best kept at a temperature between 1 to 30 degrees Celsius. This will help maintain the drug's efficacy.

Appearance

Bright yellow round film-coated tablets

Package unit

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