Jatol Tablet 2.5 mg (Rivaroxaban)

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 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 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. Since patients who have experienced acute coronary syndrome remain at risk of cardiovascular events, extending the duration of treatment may be beneficial. Treatment with this medicine at 2.5mg should be initiated as soon as possible after stabilization of the acute coronary syndrome event (including revascularization). Treatment may be started 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 with aspirin 75-100mg once daily. The duration of treatment with this medicine should be determined through regular assessment of each patient's condition, taking into consideration the risk of bleeding versus thrombotic events. During treatment with this medicine, for patients who experience an acute thrombotic event, undergo a vascular procedure, or require dual antiplatelet therapy, continuation of 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 administered 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 miss a dose of this medicine If you miss a dose, 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 After taking this medicine, the INR value will be falsely elevated, regardless of the dose. INR is not suitable 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. 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. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer a dose based on INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, INR should not be tested 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 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 this population. 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 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 correctly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat thrombosis by inhibiting blood coagulation. During treatment, bleeding may occur; therefore, signs of bleeding should be closely monitored, especially in patients at high risk of bleeding. If severe bleeding occurs, discontinue this medication immediately and consult healthcare personnel. This medication should not be used in patients with specific bleeding disorders or liver disease, pregnant or nursing women, and those with certain genetic lactose metabolism disorders. Patients with a history of gastrointestinal ulcers, intracranial hemorrhage, or malignant tumors with a high risk of bleeding should also avoid this medication. Careful consideration is required when administering this medication in combination with other anticoagulants or certain antifungal agents due to an increased risk of bleeding. Patients with impaired renal function or bleeding risk conditions should use this medication cautiously, considering the risk of bleeding against the benefits of treatment. This medication may cause side effects such as bleeding, anemia, gastrointestinal disturbances, skin rash, and in severe cases, allergic reactions or severe skin reactions. Signs of bleeding include pallor, dizziness, headache, shortness of breath, etc. If these symptoms occur, consult a physician immediately. Before undergoing surgery or invasive procedures, this medication should be discontinued for a specified period and adjusted according to the healthcare personnel's instructions. This medication should not be taken during pregnancy and women who may become pregnant should use contraception while taking it. Nursing women should also avoid this medication and should only resume after stopping breastfeeding if necessary. Elderly patients may have increased blood concentrations due to reduced renal function, but dosage adjustments are generally not necessary. This medication is not recommended for children and adolescents under 18 years as its safety and effectiveness have not been established. Overdose may increase the risk of bleeding; therefore, the prescribed dosage must be adhered to, and if overdose is suspected, contact a medical institution immediately. During treatment with this medication, caution is advised when driving or operating machinery due to possible drowsiness or dizziness. There may be interactions with other medications; therefore, inform healthcare personnel of any other medications being taken. Regular monitoring such as blood tests is important to evaluate the risk of bleeding and medication effectiveness during treatment.

Hemorrhage, anemia, thrombocytosis, tachycardia, eye hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, indigestion, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, pseudovascular aneurysm, increased transaminases, elevated bilirubin levels, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, epistaxis, hemoptysis, pruritus, rash, petechiae, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, vascular edema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions associated with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, significant uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, black stools, arthralgia, myocardial infarction, deep vein thrombosis, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulceration, high fever, severe dysphagia, cardiac ischemic symptoms, compartment syndrome, renal failure

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1°C and 30°C room temperature. This will help preserve the medication's effectiveness and safety.

Appearance

Bright yellow round film-coated tablet

Package unit

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