Cavaban 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 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 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 events persists in patients who have experienced acute coronary syndrome, extending the treatment period may be beneficial. Treatment with this medicine 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, 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, 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, in patients who experience an acute thrombotic event or undergo a vascular procedure and require dual antiplatelet therapy, continued treatment with this medicine 2.5mg twice daily should be assessed according to the antiplatelet regimen and the type of thrombotic event or vascular procedure. The efficacy and safety of this medicine administered in combination with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. The use of this medicine in combination 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 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 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. 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, then adjust the dose according to INR test results. However, in patients receiving this medicine together with a vitamin K antagonist, INR testing should not be performed 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 In patients receiving a parenteral anticoagulant, initiate 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 initiate the parenteral anticoagulant at the time of the next scheduled dose of this medicine. 3. Patients with renal impairment No dose adjustment is required in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Use of this medicine is not recommended in patients with severe renal impairment (creatinine clearance less than 15 mL/min), as 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 accompanied by 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 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 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 is used to prevent or treat blood clots by preventing excessive coagulation. However, during the administration of this drug, careful monitoring for signs of bleeding is necessary, especially in cases at high risk for bleeding. If serious bleeding occurs, the use of this medication should be stopped immediately. Although routine blood concentration monitoring is not necessary, checking the drug levels can be helpful in emergency situations. This medication should not be given to certain patients, including those with allergies to the active ingredient or components, patients who are already experiencing significant bleeding, patients with severely impaired liver function, women who are pregnant or breastfeeding, and patients with certain genetic disorders such as lactose intolerance. Furthermore, avoid use in patients with recent gastrointestinal ulcers, a history of brain hemorrhage, vascular abnormalities, patients at high risk for bleeding due to malignancies, or those using other anticoagulants or certain antifungals. Patients with reduced kidney function or diseases that increase bleeding risk, as well as those taking medications that affect hemostasis, should use this drug cautiously. Notably, increased bleeding risk may arise when used with antiplatelet agents. Common adverse reactions may include anemia, bleeding, headache, nausea, abdominal pain, fever, and edema, and in rare cases, serious skin reactions or blood disorders may occur. If bleeding is severe, symptoms like dizziness, pallor, and breathing difficulty may manifest, necessitating immediate medical attention. In elderly patients with reduced kidney function, blood concentration may increase; however, dosage adjustment is generally not needed. This medication is not recommended for children or adolescents under 18 years of age, as its safety and efficacy have not been established in this population. In cases of overdose, careful observation for bleeding complications is essential. Activated charcoal can reduce absorption, but it is not removed through dialysis. Drowsiness or fainting may occur during the use of this medication, so caution is advised while driving or operating machinery. Additionally, this medication can interact with certain antifungals, HIV treatments, and some antibiotics to increase blood concentrations and bleeding risk; therefore, consultation with healthcare personnel is required before co-administration with these drugs. Conversely, some medications may decrease the effect of this drug, so caution is necessary. Pregnant women should not use this medication, and women of childbearing potential must use contraception during treatment. Breastfeeding women should also avoid taking this medication. This drug is crucial for regulating blood coagulation; therefore, it is imperative to inform healthcare personnel before any surgical or invasive procedures and take appropriate measures to stop or resume the medication at the correct time. Particularly in patients receiving neuraxial anesthesia, there is an increased risk of severe complications due to hemorrhage.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, indigestion, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, elevated transaminases, increased bilirubin levels, elevated alkaline phosphatase, increased LDH, elevated lipase, increased amylase, increased enzyme levels, elevated bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, epistaxis, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-associated kidney disease, surgical site bleeding requiring reoperation, bleeding necessitating hospitalization, major gastrointestinal bleeding, significant intracranial bleeding, major uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, hematochezia, myocardial infarction, arthralgia, facial flushing, deep vein thrombosis, cardiomyopathy, elevated cardiac enzymes, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, influenza-like syndrome, drug hypersensitivity reaction

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. It is advisable to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

Bright yellow circular film-coated tablet

Package unit

PTP - 30 tablets/box [(10 tablets/PTP x 3)], PTP - 100 tablets/box [(10 tablets/PTP x 10)]