Rivaroxaban 20 mg Tablets

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered 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. 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 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 individualized assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative to 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 From day 22: 20mg once daily, total daily dose 20mg Reduction of the risk of recurrence of 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 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 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 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. 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 medicine 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 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 treatment with the vitamin K antagonist and start taking this medicine when the INR is ≤ 2.5. Regardless of the dose, INR values 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 while switching to another anticoagulant. Note that this medicine may affect INR elevations. 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. In contrast, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be tested until 24 hours have elapsed after taking this medicine. Once this medicine has been discontinued, INR may be tested 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 blood concentrations of this medicine increased significantly; therefore, administer this medicine with caution. Administration 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 these patients. 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 required 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 are 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 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 blood clot formation by inhibiting blood clotting. When taking this medication, the risk of bleeding may increase, so careful observation for symptoms or signs of bleeding is necessary. If severe bleeding occurs, the use of this medication should be stopped immediately and appropriate treatment should be received as directed by a physician. This medication should not be administered to certain patients, such as those who have allergies to this medication or its ingredients, those with severe bleeding, those with seriously impaired liver function, women who are pregnant or nursing, and patients with genetic issues like lactose intolerance. Patients with recent gastrointestinal ulcers, intracranial hemorrhage, history of spinal or brain surgery, vascular anomalies, or malignancies that increase the risk of bleeding should not use this medication. The risk of bleeding may increase when used in combination with other anticoagulants or certain antifungal medications, so special caution is required when taking these medications together. Patients with decreased kidney function or those with diseases that increase bleeding risk should be given this medication with caution, as well as those taking medications that increase bleeding risk (such as non-steroidal anti-inflammatory drugs, platelet aggregation inhibitors). During treatment, always pay attention for bleeding symptoms or anemia symptoms (fatigue, pallor, dizziness, etc.), and it is advisable to regularly check blood tests for condition monitoring. Before surgery or invasive procedures, this medication should be temporarily stopped for a certain period, and after the procedure, it should be resumed as directed by a physician. This medication can pose risks to the fetus during pregnancy; therefore, it should not be taken by women who are pregnant or planning to conceive, and contraception must be practiced during use. Elderly patients may have increased blood levels of this medication due to decreased kidney function, and while dosage adjustments are generally unnecessary, the risk of bleeding may be increased. This medication is not recommended for children or adolescents under 18 years of age due to insufficient evidence of safety and efficacy. Overdose may result in a significantly increased risk of bleeding; medical attention should be sought immediately if this occurs. Patients should exercise caution while driving or operating machinery, as symptoms such as drowsiness or fainting may occur after taking this medication. During the treatment period, if there are any symptoms of bleeding, allergic reactions, or severe skin rashes, immediate consultation with a physician is required. Additionally, this medication may interact with certain drugs, so anyone taking other medications should inform their healthcare provider.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general reduction in strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusion, discharge from the wound area, vascular pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, increased conjugated bilirubin, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial hemorrhage, syncope, genitourinary bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions associated with systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine bleeding, syncope, drowsiness

This medication should be stored in a tightly closed container, protected from air and moisture, and at room temperature between 1 and 30 degrees Celsius. Storing in this manner helps maintain the efficacy of the medication and prevents degradation.

Appearance

Brownish red round film-coated tablets

Package unit

30 tablets/bottle