Rivaroxaban 20 mg Tablets (Rivaroxaban)

Adult dose

This 10 mg tablet may be taken with or without food, whereas the 15 mg and 20 mg tablets should be taken with food. 1. Adults 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose of this drug 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 drug is 20 mg. There is limited experience in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement, in whom rivaroxaban 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] was coadministered with a P2Y12 inhibitor for up to 12 months. 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended initial dose of this drug 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 the treatment of deep vein thrombosis and pulmonary embolism, and the recommended dose for reducing the risk of recurrence, is 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 and dose of treatment should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism compared with the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21: 15mg twice daily, 30mg From day 22: 20mg once daily, 20mg Reduction of 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 of this drug is 30 mg during the first 3 weeks of treatment and 20 mg during the subsequent 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 drug is 10 mg once daily. The initial dose should be started 6~10 hours after surgery, once hemostasis has been established. The duration of treatment depends on the individual 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 drug If you forget to take this drug, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this drug immediately; in this case, 2 tablets of 15 mg may be taken at one time. 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 drug ① Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue treatment with the vitamin K antagonist and start taking this drug when the International Normalized Ratio (INR, International Normalized Ratio) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Discontinue treatment with the vitamin K antagonist and start taking this drug when the INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this drug. The INR is not suitable for measuring the anticoagulant activity of this drug and should not be used for this purpose. 2) Switching from this drug to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this drug to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously when switching to another anticoagulant. Note that this drug may affect the increase in INR. Patients switching from this drug to a vitamin K antagonist should receive both this drug and the vitamin K antagonist until the INR is ≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer a dose of the vitamin K antagonist based on INR testing. On the other hand, in patients receiving this drug and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this drug. Once this drug has been discontinued, INR testing may be performed 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this drug In patients receiving a parenteral anticoagulant, start this drug 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low molecular weight heparin), or at the time of discontinuation of a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 4) Switching from this drug to a parenteral anticoagulant Discontinue this drug and start the parenteral anticoagulant at the time the next dose of this drug 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 plasma concentration of this drug increased significantly; therefore, administer this drug with caution. Administration of this drug is not recommended in patients with severe renal impairment with creatinine clearance below 15 mL/min because there is no clinical experience in this population. 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose in 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 of 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). 4. Patients with hepatic impairment Avoid administration of this drug in patients with liver disease associated with coagulopathy and in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. 5. For patients who cannot swallow tablets, Immediately before use, this drug may be crushed, mixed with water or a beverage such as applesauce, and administered orally. This drug may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this drug through a gastrointestinal tube, confirm that the tube is properly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat the formation of blood clots by inhibiting blood coagulation. During treatment with this drug, bleeding may occur, so patients should carefully monitor for symptoms such as nosebleeds, gum bleeding, easy bruising, or blood in urine or stools. If severe bleeding occurs, discontinue this medication immediately and seek medical attention. This medication should not be administered to patients with certain liver diseases or those at high risk of bleeding, as well as pregnant or breastfeeding women, and patients with lactose intolerance. Patients with impaired kidney function or those with diseases that increase bleeding risk, or those taking other anticoagulants or medications affecting blood coagulation should use this drug with caution. While regular blood tests are not necessary during treatment with this medication, inform healthcare providers if bleeding symptoms or anemia symptoms develop. If undergoing surgery or invasive procedures, inform healthcare providers in advance about the use of this medication and it may be necessary to discontinue it for a period prior to the procedure. There are drugs that should not be used concurrently, so consult your doctor or pharmacist regarding any other medications currently being taken. In elderly patients, the blood concentration of this drug may increase due to impaired kidney function, so there is a greater risk of bleeding. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, and proper contraception should be practiced during treatment. This medication can cause dizziness, drowsiness, or fainting, so caution is needed when driving or operating machinery. Overdosage may increase the risk of bleeding, so follow the prescribed dosage carefully, and if overdose is suspected, inform medical personnel immediately. If allergy symptoms such as skin rash, itching, mucosal ulcers, or high fever occur while taking this medication, discontinue use immediately and consult a healthcare provider.

• Bleeding
• anemia
• thrombocytosis
• tachycardia
• ocular hemorrhage
• gingival bleeding
• gastrointestinal bleeding
• gastric pain
• abdominal pain
• dyspepsia

Store this medication in a tightly closed container to protect it from air and moisture, with the safest storage temperature between 1 to 30 degrees Celsius. Therefore, avoid direct sunlight, high temperatures, and humid places, and it is best to keep it in a cool, dry location.

Appearance

Brownish red round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTPX3]