Rivaroxaban 20 mg Tablets (Rivaroxaban)

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 of this medicine 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 of this medicine is 20 mg. There is limited experience with concomitant use of rivaroxaban 15 mg once daily [10 mg 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 of this medicine 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 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 following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Duration of administration / Frequency of administration / 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 administration for at least 6 months / 10mg once daily / 10mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter during the treatment period. 3) Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement) The recommended dose of this medicine is 10 mg once daily. The first dose should be taken 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; however, a treatment duration of 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, two 15 mg tablets 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 medications 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) 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, as 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 the elevation of the INR. Patients switching from this medicine to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until the INR is ≥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 and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this medicine. Once this medicine has been 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 agent (e.g., low-molecular-weight heparin), or at the time the 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 (creatinine clearance 50-80 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the blood concentration of this medicine increased significantly; therefore, administer this medicine with caution. Use of this medicine is not recommended in patients with severe renal impairment and creatinine clearance below 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 necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 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. This medicine may also be crushed and administered with a small amount of water through an enteral feeding tube. Before administering this medicine through an enteral feeding tube, confirm that the tube is correctly positioned, and flush the tube with water after administration.

This medication prevents or treats the formation of blood clots by inhibiting blood coagulation. Therefore, it may increase the risk of bleeding, so patients should be closely monitored for symptoms or signs of bleeding. It should not be used in patients who are already bleeding or are at high risk for bleeding. Patients with severe liver impairment, pregnant or breastfeeding women, and those with certain genetic lactose intolerance conditions should also not take this medication. Moreover, patients with a recent history of gastrointestinal ulcers or intracranial hemorrhage, those who have undergone surgery on the brain or spinal cord, and those with specific vascular abnormalities may have an increased risk of bleeding while taking this medication. The risk of bleeding may increase when used in combination with other anticoagulants or certain antifungal medications, so it is essential to consult a physician. Patients with impaired kidney function may also experience increased blood concentration of this medication, raising the risk of bleeding; they should use it cautiously. During treatment, patients should watch for signs of bleeding and anemia, and report any unusual symptoms to their healthcare provider immediately. In cases of severe bleeding, it may be necessary to discontinue the medication and seek appropriate treatment, which may vary depending on the site of bleeding. Elderly patients may have elevated blood concentrations due to decreased kidney function, although specific dosage adjustments may not be required, the risk of bleeding can increase. This medication may be harmful to the fetus during pregnancy; therefore, women of childbearing potential should take precautions to avoid pregnancy, and breastfeeding should be discontinued prior to taking this medication. If surgery or invasive procedures are planned, the medication should be discontinued for a certain period beforehand, and the timing of re-administration should be determined based on the risk of bleeding after the procedure. Caution should be exercised as drowsiness or fainting may occur while driving or operating machinery. During the course of taking this medication, inform your doctor and pharmacist of all medications currently being taken, especially those that may increase the risk of bleeding.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized decrease in strength and energy, discomfort, local edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound site secretion, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, elevated transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intrcranial hemorrhage, syncope, urogenital bleeding, renal impairment, non-hemorrhagic, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, 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, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, black stools, deep vein thrombosis, joint pain, Pseudomonas aeruginosa wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, influenza-like symptoms, drug hypersensitivity reactions, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, phlegm disease, asthma, laryngitis, dysphagia, intestinal motility disorders, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urinary disorders, kidney stones, bladder malignancy, prostatic hyperplasia, Stevens-Johnson syndrome

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, avoid extremely cold or hot conditions, and it is best to store it at room temperature between 1 to 30 degrees Celsius.

Appearance

Brownish red round film-coated tablet

Package unit

7 tablets/PTP, 30 tablets/PTP [(10 tablets/PTP packaging x 3)], 100 tablets/PTP [(10 tablets/PTP packaging x 10)]