Jarovan Tablet 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. Because the risk of cardiovascular symptoms persists in patients who have experienced acute coronary syndrome, extending the treatment period 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 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 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 at 2.5mg twice daily should be evaluated according to the antiplatelet therapy and the type of thrombotic event or vascular procedure. The efficacy and safety of concomitant administration of this medicine 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 forget to take this medicine If you forget to take this medicine, continue taking the recommended dose of 2.5mg at the next scheduled time. 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 Regardless of the dose, INR values will be falsely elevated after taking this medicine. 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 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 the dose of the vitamin K antagonist 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 may be tested 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine For patients receiving a parenteral anticoagulant, initiate this medicine 0~2 hours before the time of the next scheduled parenteral dose (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 necessary in patients with mild renal impairment with creatinine clearance of 50-80 mL/min. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance below 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 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 drink 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 correctly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat blood clots by inhibiting coagulation. There is a risk of bleeding while taking this medication, so careful monitoring for signs of bleeding is necessary. If severe bleeding occurs, this medication should be discontinued immediately, and medical consultation is advised. This drug is contraindicated for certain patients, such as those who are allergic to this drug or its components, those with current severe bleeding, patients with severely impaired liver function, pregnant or nursing women, and patients with certain genetic lactose intolerance. Administration should also be avoided in patients with recent gastrointestinal ulcers or history of intracranial hemorrhage, those who have undergone brain or spinal surgery, patients with high-risk malignant tumors, and in cases where used in combination with other anticoagulants. Caution is warranted when administered to patients with reduced renal function or those with diseases that increase bleeding risk since the risk of bleeding may be elevated. This drug may cause various side effects, with the most common being bleeding, including anemia due to bleeding, gastrointestinal bleeding, and gum bleeding. Additionally, skin rash, liver function abnormalities, changes in platelet count, dizziness, headache, etc., may occur. Severe adverse reactions such as serious skin reactions or agranulocytosis should be reported to healthcare providers immediately. Blood tests should be regularly performed while on this medication to reduce the risk of bleeding, and any symptoms of bleeding or anemia should be reported to a healthcare provider promptly. The use of this drug is not recommended during pregnancy or breastfeeding, and women who may become pregnant must engage in contraception while taking this medication. In the elderly, the concentration in the blood may increase due to reduced kidney function; while dosage adjustments are generally not needed, the risk of bleeding may increase. In cases of overdose, the bleeding risk increases significantly, and appropriate medical treatment should be sought immediately. This drug can interact with certain medications, potentially increasing the risk of bleeding when taken concurrently, so other medications being taken should be disclosed to healthcare providers. Finally, before surgery or invasive procedures, the use of this medication should be discontinued for a certain period as directed by healthcare professionals.

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

This medication should be stored in a tightly closed container to prevent air or moisture from entering and should be kept at a temperature between 1 to 30 degrees Celsius. It is advisable to avoid direct sunlight, excessively hot places, and extremely cold conditions.

Appearance

Bright yellow, round film-coated tablets

Package unit

30 tablets / PTP (10 tablets / PTP x 3)