Rivaroxaban Tablet 15mg (Rivaroxaban)

Adult dose

This 10 mg dose may be taken with or without food, whereas 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 of this drug 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 drug is 20 mg. There is limited experience with concomitant administration of rivaroxaban 15mg once daily [10mg once daily for 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 drug 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 the treatment dose 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 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 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 drug 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 drug is 10 mg once daily. The first dose should be administered 6~10 hours after surgery, once hemostasis has been confirmed. 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 drug If you forget to take this drug, take the missed dose as follows. ①Patients taking 15 mg twice daily: Take this drug immediately; in this case, two 15 mg tablets may be taken at once. Starting the next day, continue taking 15 mg twice daily. ②Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the next 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 drug ①Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist treatment and start taking this drug 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 drug when the INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this drug. The INR is not suitable for measuring the anticoagulant activity of this drug and should not be used for this purpose. 2) Switching from this drug to a vitamin K antagonist Inadequate anticoagulation may occur when switching from this drug to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously when switching to another anticoagulant. Note that this drug may affect the increase in INR. Patients switching from this drug 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; thereafter, administer the dose of the vitamin K antagonist based on INR testing. However, in patients receiving this drug and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours have elapsed after taking this drug. Once this drug is discontinued, INR testing may be performed 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this drug In patients receiving a parenteral anticoagulant, start this drug 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low-molecular-weight heparin), or at the time the continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 4) Switching from this drug to a parenteral anticoagulant Discontinue this drug and start the parenteral anticoagulant at the time the next dose of this drug 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 the blood concentration of this drug increased significantly; therefore, this drug should be administered with caution. Administration of this drug 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 patients with 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 required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 4. Patients with hepatic impairment Avoid administration of this drug 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 drug and an increased risk of bleeding may occur in these patients. 5. For patients unable to swallow tablets, Immediately before use, this drug may be crushed and mixed with a liquid such as water or applesauce for oral administration. This drug may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this drug through a gastrointestinal tube, confirm that the tube is properly positioned, and flush the tube with water after administration.

This medication functions to prevent blood from clotting and is used for the prevention and treatment of thrombosis. While taking this medication, bleeding may occur, so it is important to monitor for signs or symptoms of bleeding. If severe bleeding occurs, discontinue this medication immediately and consult a healthcare provider. This medication should not be used in patients with certain liver diseases, pregnant or breastfeeding women, and specific genetic lactose intolerant patients. Patients with specific conditions such as high bleeding risk gastrointestinal ulcers, history of intracranial hemorrhage, and vascular abnormalities should also avoid this medication for safety reasons. Using this medication in conjunction with other anticoagulants or certain antifungal agents may increase the risk of bleeding, so it is essential to inform your healthcare provider of any medications you are taking. Patients with impaired renal function or those at high risk of bleeding must use this medication cautiously, weighing the risk of bleeding against therapeutic effectiveness. Monitor for symptoms of both bleeding and anemia, and conduct blood tests to check status if necessary. If bleeding occurs, appropriate treatment including physical pressure, hemostatic measures, and blood product administration should be provided, and specific coagulants may be used in emergencies. Elderly patients or those with weakened renal function may have increased drug levels, so they should be more cautious concerning bleeding risk. This medication may pose a risk to the fetus during pregnancy, so contraception is advisable, and it should be avoided while breastfeeding. This medication should be discontinued for a certain period before surgical procedures or invasive treatments, and the timing of re-dosing should be determined based on bleeding risk and recovery status post-procedure. Care should be taken when operating vehicles or machinery as drowsiness or fainting may occur as side effects of this medication. If unusual skin rashes, mucosal ulcers, or high fever occur while taking this medication, notify a healthcare provider immediately. This medication is not recommended for children and adolescents as its safety and efficacy have not been established. In cases of overdose, the risk of bleeding increases, so it is crucial to adhere to prescribed doses and consult a healthcare provider immediately if an overdose occurs.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal hemorrhage, stomachache, abdominal pain, indigestion, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment hemorrhage, bruising, wound discharge, vascular pseudoaneurysm, increase in transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital hemorrhage, renal impairment, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous hemorrhage, hives, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, bile duct obstruction, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal pathology, reported joint pain as serious adverse event under reevaluation, unspecified bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, myocardial infarction, facial flushing, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, cardiomyopathy, increase in cardiac enzymes, congestive heart failure, urinary tract infection, pseudomembranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine bleeding, postoperative anemia, wound site bleeding

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is best kept at room temperature, between 1 and 30 degrees Celsius. This will help maintain the drug's effectiveness and safety.

Appearance

Brown, round, biconvex, film-coated tablet

Package unit

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