Rivaroxaban Tablets 20 mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be taken with or without food, while 15 mg and 20 mg should be taken with food. Reduction of 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. Patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement: 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. Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent 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, 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 of treatment and dose should be determined after an individual assessment of the risk of recurrent 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, total daily dose 30mg Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence, from Day 22: 20mg once daily, total daily dose 20mg Reduction of the risk of recurrent deep vein thrombosis or pulmonary embolism, after at least 6 months of treatment: 10mg once daily, total daily dose 10mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. 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 given 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; a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for those undergoing knee replacement. If a dose of this medicine is missed, patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at one time. From the next day, continue taking 15 mg twice daily. If a dose of this medicine is missed, patients taking 10, 15, 20 mg once daily: Take the missed dose immediately. From the next day, continue taking 1 tablet once daily. The daily dose must not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this medicine, reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: Discontinue vitamin K antagonist therapy and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. Switching from a vitamin K antagonist to this medicine, treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism: Discontinue vitamin K antagonist therapy 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 is not suitable for measuring the anticoagulant activity of this medicine and should not be used. Inadequate anticoagulation may occur while switching from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously when switching to another anticoagulant. It should be noted that this medicine may affect the increase in INR. Patients switching from this medicine to a vitamin K antagonist should receive both medicines until the INR is ≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist according to INR testing. However, in patients receiving this medicine concomitantly 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. 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 of discontinuation of a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 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. No dose adjustment is necessary in patients with mild renal impairment with 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. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min because there is no clinical experience in this population. Patients with renal impairment, 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. Patients with renal impairment, treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrent 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). Avoid use 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. For patients who are unable to swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as applesauce, and administered orally. This medicine 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 properly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat blood clots by inhibiting blood coagulation. During treatment, there may be a risk of bleeding, so if signs or symptoms of bleeding occur, consult a doctor immediately. Particular care should be taken with patients at high risk for bleeding, and if severe bleeding occurs, the medication should be discontinued immediately. This medication should not be used in patients with significant liver disease, severe bleeding, pregnant or breastfeeding women, or patients with certain genetic lactose intolerance. Additionally, it should be avoided in patients with a recent history of gastrointestinal ulcers or intracranial hemorrhages, vascular abnormalities, malignancies, or other conditions that pose a high risk of bleeding. The risk of bleeding may increase when used in conjunction with other anticoagulants or certain antifungal medications, so it is essential to inform the doctor of all medications being taken. Patients with impaired kidney function, poorly controlled hypertension, or gastrointestinal disorders should be monitored carefully for bleeding risks. This medication may also cause side effects such as bleeding, anemia, rash, liver function abnormalities, etc.; if any unusual symptoms appear, consult a doctor immediately. When undergoing surgery or invasive procedures, the medication should be discontinued for a specified period, and the timing of re-administration should be determined considering the bleeding risks post-procedure. Pregnant women should avoid taking this medication as it may pose a risk to the fetus, and women of childbearing age should ensure adequate contraceptive measures during treatment. Elderly patients may have an increased risk of bleeding; however, dosage adjustments are not typically required. In case of overdose, the risk of bleeding may be significantly increased, so adherence to prescribed dosages is crucial, and immediate medical attention should be sought if overdose is suspected. Patients should be cautious while driving or operating machinery as dizziness or fainting may occur. This medication can interact with specific enzymes, so if other medications are being used, inform the doctor or pharmacist. Regular blood tests to monitor for bleeding and blood status can be beneficial during treatment. To reduce bleeding risks, adhere strictly to the prescribed dosage and administration methods as instructed by healthcare professionals.

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 weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, increased LDH, elevated lipase, increased amylase, increased transaminases, increased bilirubin conjugate, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial hemorrhage, syncope, genitourinary bleeding, renal failure, 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, eosinophilia, drug reaction accompanied by systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, deep vein thrombosis, joint dislocation, arthralgia, Pseudomonas aeruginosa wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, pseudomembranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulcer, high fever, severe dysphagia, ischemic heart symptoms, flu-like syndrome, drug hypersensitivity reaction

This medication should be stored in a tightly closed container to prevent contact with air or moisture, and kept at room temperature, between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and ensure safe usage.

Appearance

Brownish-red round film-coated tablets

Package unit

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