Rivaroxaban 20 mg Tablet

Adult dose

This 10 mg medicine may be taken with or without food, whereas the 15 mg and 20 mg doses should be taken with food. 1) 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. There is limited experience with concomitant administration of rivaroxaban 15mg once daily [10mg once daily for 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 of 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 the 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 Frequency of administration Daily dose 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 medicine 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 of this medicine 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; 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 one time. From the following day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the following day, continue taking one 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 of 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 of 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 should be maintained continuously when 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 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 a dose of the vitamin K antagonist 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 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 taken. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment with a creatinine clearance of 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 medicine increased significantly; therefore, use this medicine with caution. There is no clinical experience in patients with severe renal impairment with a creatinine clearance below 15 mL/min; therefore, use of this medicine is not recommended. 1) Reduction of 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 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 administering this medicine 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 medicine and an increased risk of bleeding may occur in these patients. 5. Patients who cannot swallow tablets, Immediately before use, this medicine may be crushed and mixed with a liquid such as water or applesauce for oral administration. 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 correctly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat the formation of clots by inhibiting blood coagulation. However, there is a risk of bleeding, so it is essential to carefully monitor for any bleeding symptoms. If serious bleeding occurs, this medication should be discontinued immediately. Generally, routine blood level tests for this medication are not necessary, but blood level testing may be helpful in cases of overdose or emergency surgery. This medication should not be used in patients with a known allergy to it, those with clinically significant bleeding, patients with severely impaired liver function, pregnant or breastfeeding women, or those with specific genetic lactose metabolism disorders. Additionally, patients with a recent history of gastrointestinal ulcers, cerebral hemorrhage, spinal or vascular abnormalities, a history of surgery or injury to the brain or spinal cord, or patients with malignancies that have a high risk of bleeding should not take this medication. Patients with impaired kidney function or those with diseases that have a high risk of bleeding, as well as those taking medications that increase bleeding risk such as non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors, should use this medication cautiously. Especially because the risk of bleeding may increase, it should only be administered under a doctor's judgment when the therapeutic benefits outweigh the risks. Various side effects such as bleeding, anemia, dyspepsia, fever, swelling, headache, dizziness, and skin rash may occur during the use of this medication. If severe bleeding occurs, immediate notification to medical personnel is required, and appropriate treatment based on the bleeding site is necessary. This medication may interact with certain antifungal agents, antibiotics, anticoagulants, and non-steroidal anti-inflammatory drugs, increasing the risk of bleeding, so caution is advised when used concurrently. Pregnant or breastfeeding women should not take this medication, and those who may become pregnant should use contraception during treatment. In the elderly, kidney function may decline, potentially leading to increased blood levels of this medication; however, dosage adjustments are generally not required. It is not recommended for individuals under 18 years of age, as its safety and efficacy have not been established in this group. In the case of an overdose, the risk of bleeding increases, so immediate medical attention is necessary, and dialysis may be ineffective in removing this medication. Drowsiness or fainting can occur while taking this medication, requiring caution when driving or operating machinery. This medication should be discontinued for a specified period before undergoing surgery or invasive procedures, and the timing of re-administration should consider the risk of bleeding postoperatively. Stopping this medication abruptly can increase the risk of thrombosis, so it is essential to consult a healthcare professional when discontinuing treatment.

Bleeding, anemia, thrombocythemia, tachycardia, ocular bleeding, gum bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy loss, discomfort, localized edema, liver impairment, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusions, secretions at the wound site, vascular pseudoaneurysm, increased transaminases, increased bilirubin in the blood, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial bleeding, syncope, urogenital bleeding, renal impairment, non-bleeding, 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 associated with drug reactions, eosinophilic pneumonia, anticoagulant-related renal disease, postoperative hematoma, hemorrhagic duodenal ulcer, blood in stool, melena, myocardial infarction, arthralgia, fever, unexplained bleeding

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it should be stored at room temperature between 1°C and 30°C, away from extreme heat or cold.

Appearance

Round film-coated tablet with a reddish-brown color

Package unit

7 tablets/PTP, 30 tablets/PTP [10 tablets/PTP packaging X3], 100 tablets/PTP [10 tablets/PTP packaging X10]