Rivaroxaban 15 mg Tablets (Rivaroxaban)

Adult dose

This 10 mg dose may be taken with or without food; the 15 mg and 20 mg doses 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 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 is 20 mg. There is limited experience with concomitant administration of rivaroxaban 15 mg once daily [10 mg 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 of the risk of recurrent deep vein thrombosis and pulmonary embolism The recommended initial dose 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 10 mg once daily. The duration of treatment and dose should be determined following an individual assessment of the risk of recurrent deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment period Dosing frequency Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21 15 mg twice daily 30 mg From day 22 20 mg once daily 20 mg Reduction of the risk of recurrent deep vein thrombosis or pulmonary embolism After at least 6 months of treatment 10 mg once daily 10 mg The maximum daily dose 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 is 10 mg once daily. The initial 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 those undergoing knee replacement. 4) If you miss a dose If you miss a dose, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take the dose 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 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 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 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. The 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 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 INR elevation. Patients switching from this medicine to a vitamin K antagonist should receive both medicines 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 the dose of the vitamin K antagonist according to INR testing. Conversely, in patients receiving this medicine together with a vitamin K antagonist, 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 agent (e.g., low molecular weight heparin), or when discontinuing 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 the next dose of this medicine 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 plasma concentrations of this medicine increased significantly; therefore, administer this medicine with caution. Administration is not recommended in patients with severe renal impairment and creatinine clearance less than 15 mL/min because 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 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). 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. Patients 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. It 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 drug prevents the formation of blood clots by inhibiting coagulation. Therefore, caution must be exercised as bleeding can easily occur, and symptoms of bleeding must be closely monitored. If severe bleeding occurs, discontinue the medication immediately and seek medical attention. Regular monitoring of drug levels is not necessary with routine blood tests, but measuring blood levels may be helpful in emergencies. This drug should not be used in patients with allergies to it, those with severe bleeding, patients with severely impaired liver function, pregnant or breastfeeding women, and those with certain genetic lactose intolerance. Caution is particularly advised for patients with recent gastrointestinal ulcers, history of intracranial hemorrhage, brain or spinal surgery, patients with diseases that have a high risk of bleeding, and those using other anticoagulants. Patients with impaired kidney function or diseases at high risk of bleeding may have an increased risk of bleeding when using this drug, and should be administered carefully under medical supervision. This medication can cause various side effects such as bleeding, anemia, gastrointestinal disorders, skin rashes, and liver dysfunction; any abnormal symptoms should be reported to healthcare providers immediately. Especially when used in conjunction with azole antifungals, certain antibiotics, other anticoagulants, or non-steroidal anti-inflammatory drugs, the risk of bleeding may increase, so consultation with healthcare providers is essential. During pregnancy, it can affect the fetus, hence contraception is necessary, and it is advisable to avoid use while breastfeeding. Elderly patients may experience elevated blood levels of this drug due to renal impairment, though special dose adjustments are not required, the risk of bleeding may be increased. Overdosing this medication can greatly increase the risk of bleeding; therefore, in cases of overdose, immediate hospital visits for appropriate treatment are necessary. Before surgeries or invasive procedures, this medication should be discontinued for a certain period. Caution is especially required during spinal anesthesia or lumbar puncture due to the high risk of serious nerve injury from bleeding. While taking this drug, drowsiness or dizziness may occur when driving or operating machinery, so such activities should be avoided while symptoms persist.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gum bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound discharge, pseudoaneurysm, increase in transaminases, increase in blood bilirubin, increase in alkaline phosphatase, increase in LDH, increase in lipase, increase in amylase, increase in transferase, increase in bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and intraventricular hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reaction with systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stool, melena, deep vein thrombosis, arthralgia, Pseudomonas 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 ulcers due to agranulocytosis, high fever, severe dysphagia, angina, significant skin rash due to Stevens-Johnson syndrome/toxic epidermal necrolysis, mucosal lesions, ischemic symptoms in the heart, compartment syndrome, renal failure, syncope, drowsiness

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is best stored at room temperature between 1°C and 30°C.

Appearance

Red round film-coated tablet

Package unit

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