Rivaroxaban 15 mg Tablet

Adult dose

This 10 mg medicine 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. 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 the 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, is 20 mg once daily. After completion of 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 versus the risk of bleeding. 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 the individual patient's risk of venous thromboembolism based on the type of surgery; treatment for 5 weeks is recommended for patients undergoing hip replacement, and 2 weeks for patients undergoing knee replacement. 4) If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this medicine 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. Do not take twice the recommended daily dose to make up for a missed dose. 2. Switching between medicines 1) Switching from a vitamin K antagonist to this medicine ① Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist treatment and start taking this medicine 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 treatment and start taking this medicine when the INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this medicine. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medicine. 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 must 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 both medicines concomitantly until the INR is ≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer a dose based on INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, 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, start this medicine 0~2 hours before the next scheduled dose of the parenteral product (e.g., low-molecular-weight heparin), or when discontinuing a continuously administered parenteral product (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 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 (creatinine clearance 50-80 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that plasma concentrations of this medicine increased significantly; therefore, administer this medicine with caution. Administration 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 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 administration of this medicine in patients with liver disease associated with coagulopathy and in 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. Patients unable to swallow tablets Immediately before use, this medicine may be crushed and mixed with water or a beverage such as applesauce for oral administration. It 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 thrombus formation by inhibiting blood coagulation. Signs of bleeding must be carefully monitored during treatment, and it should be administered cautiously in patients at high risk for bleeding. If severe bleeding occurs, this medication should be discontinued immediately, and specialized tests may be conducted to evaluate coagulation status if necessary. This medication should not be administered to patients with hypersensitivity to it, those with active bleeding, patients with severe liver dysfunction, pregnant or nursing women, or patients with lactose intolerance. Patients with recent gastrointestinal ulcers, history of intracranial hemorrhage, or prior surgery of the brain or spinal cord, as well as patients with high-risk malignant tumors for bleeding, should also avoid this medication. When taken with other anticoagulants or certain antifungals, the risk of bleeding may increase, so caution is needed when co-administering. In patients with renal impairment or those with conditions that increase bleeding risk, the blood concentration of this medication may rise, leading to an increased risk of bleeding, thus requiring careful use. Concurrent use with non-steroidal anti-inflammatory drugs (NSAIDs) or platelet aggregation inhibitors may likewise increase the risk of bleeding. Symptoms of bleeding or anemia should be closely monitored during treatment, and if any abnormal symptoms appear, healthcare professionals should be consulted immediately. This medication may increase the risk of epidural or spinal hematoma when used in conjunction with neuraxial anesthesia or lumbar puncture, so the timing of administration should be adjusted around these procedures. During pregnancy, it may pose risks to the fetus, so women of childbearing potential must use contraception while taking this medication, and nursing mothers should avoid its use. In elderly patients, renal function decline may elevate blood concentrations; however, dosage adjustment is usually not required, but the risk of bleeding may increase. In case of overdose, side effects such as bleeding may occur, requiring caution, and this medication is not removed by dialysis. Symptoms such as drowsiness or fainting may appear when driving or operating machinery, so caution is advised. Certain drug interactions may occur during treatment, so patients should inform healthcare professionals if they are taking other medications. This medication may affect blood test results, so it is important to inform the testing personnel that this medication is being taken.

Bleeding, anemia, thrombocythemia, tachycardia, ocular bleeding, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general weakness and energy reduction, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound secretion, vascular pseudoaneurysm, increased transaminases, increased bilirubin in the blood, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial and cerebral bleeding, syncope, urogenital bleeding, renal impairment, epistaxis, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia with systemic symptoms related drug reaction, eosinophilic pneumonia, anticoagulant-related kidney disease, significant uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, arthralgia, myocardial infarction, deep vein thrombosis, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulcer, high fever, severe dysphagia, angina pectoris, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, bowel motility disorder, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urinary disorders, kidney stones, bladder carcinoma, prostatic hyperplasia, influenza-like syndrome, drug hypersensitivity reaction

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain room temperature between 1°C and 30°C.

Appearance

Red round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP X 3]