Rivaroxaban 15 mg Tablets (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 coadministration 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. 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 individualized assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism compared with 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, 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 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 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 patients undergoing knee replacement. 4) If you forget to take this medicine ①Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg 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 treatment with the vitamin K antagonist and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) 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 treatment with the vitamin K antagonist 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 Patients switching from this medicine to a vitamin K antagonist should receive 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, and thereafter administer a dose 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 agent (e.g., low molecular weight heparin), or at the time a 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 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 the blood concentration of this medicine increased significantly; therefore, administer this medicine with caution. Use 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 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 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. 5. Patients who cannot swallow tablets, Immediately before use, this medicine may be crushed, mixed with water or a beverage such as applesauce, and administered orally. 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 medication is used to prevent or treat the formation of blood clots by inhibiting coagulation. While taking this medication, bleeding may occur; therefore, careful observation for signs or symptoms of bleeding is necessary. If severe bleeding occurs, this medication should be stopped immediately and medical advice should be sought. This drug is contraindicated in patients with certain diseases or conditions. For example, it should not be taken by patients with severe bleeding, patients with critically impaired liver function, pregnant or breastfeeding women, and patients with lactose intolerance. Furthermore, it should be administered cautiously to patients at high risk of bleeding, such as those with a recent history of gastrointestinal ulcers, intracranial hemorrhage, vascular abnormalities, or malignant tumors. Caution is warranted in patients with reduced kidney function or those who are taking other anticoagulants, antiplatelet drugs, or non-steroidal anti-inflammatory drugs, as this may increase the risk of bleeding. This medication may cause various side effects such as bleeding, anemia, gastrointestinal symptoms, fever, skin rash, etc.; therefore, if any unusual symptoms occur, consult a doctor immediately. Especially, if significant bleeding, allergic reactions, or severe skin rashes occur, stop taking the medication immediately and inform the healthcare provider. This drug may interact with certain antifungal agents, some antibiotics, and antiviral medications, which can increase the risk of bleeding when taken together. Therefore, inform your doctor or pharmacist about all medications you are taking. Women who are pregnant or planning to become pregnant must use contraception while on this medication, and if breastfeeding, they should stop breastfeeding before use. Elderly patients may have increased blood levels due to impaired kidney function, but dose adjustments are usually not necessary, although the risk of bleeding may be increased. Safety and efficacy in children and adolescents have not been established, so it is not recommended for use in this population. In cases of overdose, the risk of bleeding increases, so care must be taken not to exceed the prescribed dosage, and if an overdose is suspected, immediate medical attention is needed. When driving or operating machinery, precautions are necessary as dizziness or drowsiness may occur. Before surgery or invasive procedures, this medication should be stopped, and after the procedure, the timing for resuming should be determined taking into account bleeding risk and hemostasis status. Sudden cessation of anticoagulant treatment can increase the risk of thrombosis; therefore, consultation with a doctor for alternative treatment should be sought before discontinuation.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized decrease in strength and energy, discomfort, localized edema, liver impairment, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusions, wound exudate, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial hemorrhage, syncope, genitourinary bleeding, renal impairment, epistaxis, hemoptysis, pruritus, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, recurrent VTE, recurrent PE, recurrent DVT, myocardial infarction, hemorrhagic duodenal ulcer, hematochezia, melena, arthralgia, unexplained bleeding, postoperative hematoma, facial flushing, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine bleeding, postoperative syncope, drowsiness

This medication should be stored in a tightly closed container, protected from air and moisture, and it is best kept at room temperature between 1 to 30 degrees Celsius.

Appearance

Red, round, film-coated tablet

Package unit

30 tablets/PTP [(10 tablets/PTP x 3)]