Rivacor 10 mg (Rivaroxaban)

Adult dose

This 10 mg medication may be taken with or without food, while the 15 mg and 20 mg doses should be taken with food. 1. Adults 1) Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose is 20 mg once daily. The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) is 15 mg once daily. The maximum daily dose is 20 mg. There is limited experience with concomitant administration of rivaroxaban 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] and a P2Y12 inhibitor for up to 12 months in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement. (See '12. Clinical Trial Information') 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended initial dose for treatment of acute deep vein thrombosis and pulmonary embolism is 15 mg twice daily for the first 3 weeks. Thereafter, the recommended maintenance dose for treatment of deep vein thrombosis and pulmonary embolism and the recommended dose for reducing the risk of recurrence are 20 mg once daily. After completing treatment (at least 6 months) for deep vein thrombosis or pulmonary embolism, the recommended dose for extended treatment to reduce the risk of recurrence is 10mg once daily. The duration of treatment and dose should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Treatment period / Dosing frequency / Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence Days 1-21 / 15mg twice daily / 30mg From day 22 / 20mg once daily / 20mg Reduction in the risk of recurrence of deep vein thrombosis or pulmonary embolism After at least 6 months of treatment / 10mg once daily / 10mg The maximum daily dose is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. 3) Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement) The recommended dose is 10 mg once daily. The first dose should be started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of treatment depends on each patient's risk of venous thromboembolism according to the type of surgery; treatment for 5 weeks is recommended for patients undergoing hip replacement and for 2 weeks for those undergoing knee replacement. 4) If you forget to take this medication If you forget to take this medication, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take the medication immediately; in this case, 2 tablets of 15 mg may be taken at once. Starting the next day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the next day, continue taking 1 tablet once daily. 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 medication ① Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist therapy and start taking this medication when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism / reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism Discontinue vitamin K antagonist therapy and start taking this medication when the INR is ≤ 2.5. Regardless of the dose, INR values will be falsely elevated after taking this medication. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medication. 2) Switching from this medication to a vitamin K antagonist Inadequate anticoagulation may occur when switching from this medication to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously when switching to another anticoagulant. Note that this medication may affect the INR and increase it. Patients switching from this medication to a vitamin K antagonist should receive both medications until the INR is ≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter adjust its dose according to INR test results. However, in patients receiving this medication together with a vitamin K antagonist, INR should not be tested until 24 hours after taking this medication. Once this medication has been discontinued, INR may be tested 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medication In patients receiving a parenteral anticoagulant, start this medication 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low molecular weight heparin), or when the continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 4) Switching from this medication to a parenteral anticoagulant Discontinue this medication and start the parenteral anticoagulant at the time the next dose of this medication would have been due. 3. Patients with renal impairment No dose adjustment is required in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medication increased significantly; therefore, administer this medication with caution. There is no clinical experience in patients with severe renal impairment and creatinine clearance below 15 mL/min; therefore, use of this medication is not recommended. 1) Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) and severe renal impairment (creatinine clearance 15-29 mL/min) is 15 mg once daily. 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism / prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement) No dose adjustment is required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 4. Patients with hepatic impairment Avoid administering this medication 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 medication and an increased risk of bleeding may occur in these patients. 5. Patients who cannot swallow tablets, Immediately before use, this medication may be crushed and mixed with a drink such as water or applesauce for oral administration. It may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this medication through a gastrointestinal tube, confirm that the tube is correctly positioned, and flush the tube with water after administration.

This drug is used to prevent or treat thrombus formation by inhibiting excessive blood clotting. While taking this drug, careful monitoring for signs of bleeding is necessary, especially in patients at high risk of bleeding. If severe bleeding occurs, this medication should be discontinued immediately and medical guidance should be followed. This medication should not be administered to patients with certain diseases or conditions. For example, individuals with allergies to this drug's components, those currently experiencing severe bleeding, patients with significantly impaired liver function, pregnant or nursing women, and patients with genetic problems such as lactose intolerance should avoid this drug. Furthermore, patients who have recently had gastrointestinal ulcers, intracranial hemorrhage, spinal or brain surgery, and patients with high-risk malignant tumors for bleeding should also refrain from using this medication. In patients with impaired kidney function or bleeding risk diseases, or those taking medications that may increase bleeding risks such as non-steroidal anti-inflammatory drugs or antiplatelet agents, care should be taken during administration. During the use of this drug, it is important to continuously monitor for bleeding symptoms or signs of anemia, and if unexplained hypotension or anemia occurs, immediate consultation with healthcare personnel is required. If bleeding occurs, the dose should be delayed or stopped, and appropriate treatment should be administered based on the bleeding site. In particular, before any surgical or invasive procedures, this medication should be paused for a certain period, and after the procedure, it should be resumed as soon as the condition stabilizes. This drug can interact with other anticoagulants, certain antifungals, and some antibiotics, increasing the risk of bleeding, so be sure to inform healthcare personnel of any other medications you are taking. Pregnant or nursing women should not use this medication, and women who could become pregnant must use effective contraception while taking it. Elderly patients may have higher blood concentration due to declining kidney function; although adjustment of the dosage is generally not required, the bleeding risk may increase, thus caution is advised. This drug is not recommended for children or adolescents under 18 years of age, as safety and efficacy have not been established. In case of overdose, the risk of bleeding may increase, necessitating immediate medical attention, as this drug is not removed through dialysis. Drowsiness or dizziness may occur while taking this medication, thus caution is needed when driving or operating machinery. If abnormal symptoms such as bleeding, allergic reactions, or severe skin rashes appear during treatment, consult a doctor immediately.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, 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, contusions, wound secretion, pseudoaneurysm, increased transaminases, increased bilirubin levels, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital hemorrhage, renal impairment, non-hemorrhagic conditions, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, 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 nephropathy, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, melena, tarry stools, joint pain, myocardial infarction, deep vein thrombosis, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, intestinal motility disorders, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, dysuria, nephrolithiasis, bladder carcinoma, prostatic hyperplasia, influenza-like syndrome, drug hypersensitivity reactions

This medication should be kept in a sealed container to prevent exposure to air or humidity, and it is best stored at room temperature between 1 to 30 degrees Celsius. Maintaining proper temperature and container conditions ensures the drug's efficacy and safety.

Appearance

Pink, double-convex, round film-coated tablet

Package unit

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