Rivaroxaban 20 mg Tablet (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. 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 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 and dose of treatment should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment period / dosing frequency / total 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 based on 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. ①Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at once. From the following day, continue taking 15 mg twice daily. ②Patients 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 ①Reduction 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. ②Treatment 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 while 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 take the vitamin K antagonist concomitantly until the INR is ≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer a dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, INR should not be tested until 24 hours after taking this medicine. If 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 next scheduled dose of the parenteral agent (e.g., low molecular weight heparin), or when the continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 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 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 (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. 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. 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 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 properly positioned, and flush the tube with water after administration.

This medication works by inhibiting blood coagulation to prevent or treat the formation of blood clots. During treatment, the risk of bleeding may increase, and the signs or symptoms of bleeding should be carefully monitored. If severe bleeding occurs, medication should be discontinued immediately and the physician's instructions should be followed. Although routine blood level monitoring is not necessary for this drug, measuring blood concentration may be helpful in emergency situations. This drug should not be administered to certain patients. For example, those who are allergic to this drug, have severe bleeding, severely impaired liver function, pregnant or breastfeeding women, or patients with lactose intolerance should not take this medication. Caution is also necessary for patients who have had recent gastrointestinal ulcers, intracranial hemorrhage, surgery on the brain or spinal cord, or have conditions with a high risk of bleeding, as well as those taking other anticoagulants or certain antifungal medications. Patients with reduced kidney function, those with conditions that have a high risk of bleeding, patients with malignant tumors, and those concurrently taking medications that increase the risk of bleeding, such as nonsteroidal anti-inflammatory drugs or antiplatelet agents, should use this drug cautiously. Symptoms of bleeding and signs of anemia should be closely monitored, and blood tests should be conducted if necessary. This medication can cause various adverse reactions, with common side effects including anemia, bleeding, dyspepsia, nausea, headache, and dizziness. In severe cases, there is a risk of skin rash, allergic reactions, liver dysfunction, and agranulocytosis, so consult a physician promptly if any unusual symptoms arise. In elderly patients with decreased kidney function, blood concentrations may increase, however, separate dosage adjustments are usually not necessary. Safety and efficacy in individuals under 18 years of age have not been established, hence it is not recommended for use. Caution is advised for potential bleeding complications with overdose, and this drug is not removed through dialysis. If bleeding is suspected, immediate medical attention should be sought. While taking this medication, caution is required when driving or operating machinery. Dizziness or drowsiness may occur after taking the medication, so activities that require alertness should be avoided if these symptoms are present. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential must use contraception while on this medication. It is essential for women of reproductive age requiring anticoagulant therapy to discuss pregnancy planning with their physician. This medication may interact with other drugs, so any other medications being taken must be reported to the doctor or pharmacist. Extra caution is warranted when co-administering with CYP3A4 and P-gp inhibitors, anticoagulants, antiplatelet agents, some antibiotics, and antifungal medications as this may increase the risk of bleeding. If scheduled for surgery or invasive procedures, this medication should be discontinued for a certain period prior to the procedure, and after the procedure, it should be restarted only after checking for bleeding risk and hemostatic status. Abruptly stopping this medication may increase the risk of thrombosis; thus, it is essential to consult healthcare providers for appropriate alternative treatment when discontinuing.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and loss of energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reaction, allergic dermatitis, post-treatment bleeding, contusion, wound exudate, vascular pseudoaneurysm, elevated transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, elevated transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal dysfunction, non-bleeding, hemoptysis, itching, rash, petechiae, cutaneous and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, deep vein thrombosis, arthralgia, Pseudomonas wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulcer, high fever, severe dysphagia, angina, influenza-like symptoms, drug hypersensitivity reaction, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disorders, asthma, laryngitis, dysphagia, gastrointestinal motility disorders, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, dysuria, kidney stones, bladder carcinoma, prostatic hyperplasia, Stevens-Johnson syndrome

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It should be stored at room temperature, between 1 to 30 degrees Celsius, avoiding excessively hot or cold environments.

Appearance

Brownish red round film-coated tablet

Package unit

30 tablets/PTP [10 tablets/PTP × 3]