Rivaroxaban Tablets 15 mg (Rivaroxaban)

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. 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 underwent 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 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 after an individual assessment of the risk of recurrent deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Treatment period Frequency of administration 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 recurrent 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 during the remaining treatment period. 3) Prevention of venous thromboembolism in adult patients who have undergone 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 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, 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 vitamin K antagonist therapy 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 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 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 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 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, followed by a dose based on INR testing. On the other hand, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours have elapsed 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 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 required in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Administration of this medicine is not recommended in patients with severe renal impairment with 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 blood concentrations of this medicine increased significantly; therefore, administer this medicine with caution. 2) Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism No dose adjustment is required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance 15-29 mL/min. 3) Prevention of venous thromboembolism in adult patients who have undergone 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). 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. 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 who cannot swallow tablets, Immediately before use, this medicine may be crushed, mixed with a liquid such as water or applesauce, and administered orally. 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 thrombus formation by inhibiting blood coagulation. Bleeding may occur during treatment with this medication, so it is important to carefully monitor for any signs or symptoms of bleeding. If severe bleeding occurs, the use of this medication should be discontinued immediately and medical advice should be sought. This medication should not be used in patients with certain liver diseases, bleeding disorders, those who are pregnant or breastfeeding, and patients with specific hereditary lactose intolerance. Care should be taken when administering this medication to patients at high risk for bleeding, such as those with a recent history of gastrointestinal ulcers, intracranial hemorrhage, or certain vascular abnormalities. The risk of bleeding may increase when taken with other anticoagulants or certain antifungal agents; therefore, caution is needed when used concomitantly. In patients with impaired renal function or at high risk for bleeding, the risk may be further heightened, hence dosing should be based on medical judgment. This medication can affect blood test results, so it is important to regularly check for bleeding and assess blood status through blood tests. Symptoms of bleeding may include paleness, dizziness, headache, shortness of breath, and unexplained swelling; if any of these symptoms occur, medical personnel should be notified immediately. If surgery or invasive procedures are planned while taking this medication, it should be discontinued at least 12 to 24 hours in advance, and resumed once the risk of bleeding is low after the procedure. Elderly patients or those with impaired renal function may have increased blood levels of the drug, leading to a higher risk of bleeding, so caution is advised. Women who are pregnant or planning to become pregnant should ensure contraception is followed while taking this medication, and breastfeeding women should avoid using this drug. In cases of overdose, there may be an increased risk of bleeding, so immediate consultation and appropriate care are necessary. Adverse effects such as fainting or drowsiness may occur while driving or operating machinery, so caution is advised. Many drugs may interact with this medication, so be sure to inform medical personnel of any other medications being taken. Regular medical evaluations and monitoring are necessary to reduce the risk of bleeding when taking this medication.

Hemorrhage, anemia, thrombocytosis, tachycardia, eye hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, indigestion, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general reduction in strength and energy, discomfort, localized swelling, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound discharge, vascular pseudoaneurysm, increase in transaminases, elevated blood bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial bleeding, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, arthralgia reported as a reevaluation adverse event, fever, hemorrhage of unspecified origin, postoperative hematoma, myocardial infarction, hemorrhagic duodenal ulcer, melena, tarry stools, deep vein thrombosis, joint dislocation, Pseudomonas wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membrane colitis, asthma, pulmonary edema, pleural effusion, severe uterine bleeding, syncope, drowsiness

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

Red round film-coated tablets

Package unit

30 tablets (10 tablets/PTP X 3)