AhnGook NewPharm Rivaroxaban Tablet 20 mg

Adult dose

This medicine 10 mg may be administered without regard to meals, while 15 mg and 20 mg should be administered with meals. 1. Adults 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 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 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 administration to reduce the risk of recurrence is 10mg once daily. The duration of treatment and treatment 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 6 months or longer / 10mg once daily / 10mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg during the remainder of 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 given 6~10 hours after surgery, once hemostasis has been established. The duration of administration 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, 2 tablets of 15 mg 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 1 tablet once daily. The daily dose should not be doubled to make up for a missed dose. 2. Switching medicines 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 therapy 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 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. The INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used for this purpose. 2) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur when 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 increase in 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 of the vitamin K antagonist based on INR testing. On the other hand, patients receiving this medicine and a vitamin K antagonist concomitantly should not undergo INR testing until 24 hours after taking this medicine. Once this medicine is 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 time of the next scheduled parenteral dose (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 medicine to a parenteral anticoagulant Discontinue this medicine and start the parenteral anticoagulant at the time of the next dose of this medicine. 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 plasma concentrations of this medicine increased significantly; therefore, this medicine should be administered with caution. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance less than 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 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) 4. Patients with hepatic impairment Avoid administration 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. 5. For patients who cannot 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 properly positioned and flush the tube with water after administration.

This drug is used to regulate the blood coagulation process to prevent or treat thrombosis. During the use of this medication, bleeding symptoms may appear, so signs of bleeding should be monitored closely. If severe bleeding occurs, discontinue this medication immediately and consult a medical professional. This medication should not be used in patients with certain liver diseases or a high risk of bleeding, pregnant or breastfeeding women. Additionally, patients with lactose intolerance or specific genetic disorders should not take this medication. Patients with impaired renal function or diseases with a high risk of bleeding should use this medication cautiously, weighing the risks of bleeding against the benefits of treatment. When used with other anticoagulants, antiplatelet agents, or certain antifungal agents, the risk of bleeding may increase, so consultation with a doctor is essential. Side effects of this medication may include bleeding, anemia, dyspepsia, skin rash, etc., and severe allergic reactions or skin diseases should be reported to a medical professional immediately. Before undergoing surgery or invasive procedures, this medication may need to be discontinued, so consult with a healthcare provider. Elderly patients or those with impaired renal function may be at increased risk of bleeding, but dose adjustments are generally not necessary. Women who are pregnant or planning to become pregnant must ensure contraception while taking this medication, and breastfeeding women should only take this medication after stopping breastfeeding. In the case of an overdose, the risk of bleeding increases, so it is essential to adhere to the prescribed dosage and consult a healthcare provider if any abnormal symptoms occur. Caution is required as drowsiness or fainting may occur while driving or operating machinery. It is recommended to regularly check blood tests to monitor for bleeding and assess blood status during the use of this medication.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, digestive disorders, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general weakness and energy reduction, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusions, wound exudate, vascular pseudo-aneurysm, increased transaminases, increased blood bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal dysfunction, epistaxis, hemoptysis, pruritus, 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 reactions with systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, reported arthralgia as an adverse event in re-examinations, bleeding of unspecified origin, postoperative hematoma, hemorrhagic duodenal ulcer, melena, black stools, deep vein thrombosis, joint dislocation, Pseudomonas wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, elevated cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine hemorrhage, postoperative bleeding, postoperative hematoma, myocardial infarction, hemorrhagic duodenal ulcer, melena, black stools, deep vein thrombosis, facial flushing, postoperative syncope, drowsiness

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to keep the medication at room temperature between 1°C and 30°C. Avoid very hot or very cold places.

Appearance

Brownish-red circular film-coated tablet

Package unit

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