Rivaroxaban 10 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. 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 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 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 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 completion of 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 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. 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 varies according to 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 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 recurrence of 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. 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 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, and thereafter administer a dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be measured until 24 hours after taking this medicine. Once this medicine is discontinued, INR can be measured 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 administration of the parenteral agent (e.g., low molecular weight heparin), or when continuous administration of a 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 with creatinine clearance 50-80 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. There is no clinical experience in patients with severe renal impairment with creatinine clearance below 15 mL/min, so administration of this medicine is not recommended. 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. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 5. For patients who cannot swallow tablets, Immediately before use, this medicine may be crushed and mixed with a drink such as water or 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 drug is used to prevent or treat the formation of blood clots by preventing excessive clotting. While taking this medication, there may be a risk of bleeding; therefore, it is important to always monitor for signs and symptoms of bleeding. If severe bleeding occurs, the medication should be stopped immediately and medical advice sought. Regular monitoring of the drug concentration through specific blood tests is not necessary, but in cases of overdose or emergency surgery, checking the blood concentration can be helpful. This medication should not be administered to patients with an allergy to its ingredients, those with serious bleeding, patients with severely impaired liver function, pregnant or breastfeeding women, and patients with specific hereditary lactose intolerance. Caution is also needed for patients who have recently had gastrointestinal ulcers, brain hemorrhages, brain or spinal surgery, those with conditions that pose a high risk of bleeding, or those using other anticoagulants. Patients with decreased kidney function or diseases that pose a high risk of bleeding, as well as those using medications that increase bleeding risk such as non-steroidal anti-inflammatory drugs or platelet inhibitors, should use this drug with caution. This medication can cause various adverse reactions, with the most common side effects related to bleeding. Symptoms of bleeding may include gum bleeding, nosebleeds, hematuria, and bruising, which, if severe, can lead to internal bleeding, dizziness, pallor, and difficulty breathing. Rarely, serious allergic reactions or skin reactions, and severe side effects such as agranulocytosis, have been reported, so any unusual symptoms should be reported to medical personnel immediately. Elderly patients with impaired kidney function may have higher blood concentrations of the drug; however, in general, dosage adjustments are not needed, but the risk of bleeding may increase. Use during pregnancy is not recommended as it may pose risks to the fetus, and women of childbearing potential should use effective contraception during treatment. Women who are breastfeeding are also advised to discontinue breastfeeding while taking this medication. This drug is metabolized and eliminated by certain enzymes and drug transporters, so caution is needed when used in combination with certain antifungals, antibiotics, and antituberculosis medications, as drug concentrations may change. In particular, using it with strong CYP3A4 and P-gp inhibitors may significantly increase the risk of bleeding, so co-administration should be avoided. Using this drug along with other anticoagulants such as warfarin, non-steroidal anti-inflammatory drugs, or platelet inhibitors may increase the risk of bleeding, so it should be taken under the direction of a physician. Before surgery or invasive procedures, this medication should be paused for a while, and once the risk of bleeding decreases post-procedure, it can be resumed. Sudden discontinuation of this drug can increase the risk of thrombosis, so it is vital to consult medical personnel for appropriate alternative treatment before stopping. The effects on driving or operating machinery are unclear, but if dizziness or drowsiness occurs after taking the medication, driving should be avoided.

Bleeding, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gum bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized fatigue and energy depletion, discomfort, localized edema, liver dysfunction, jaundice, allergic reaction, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increase in transaminases, increase in serum bilirubin, increase in alkaline phosphatase, increase in LDH, increase in lipase, increase in amylase, increase in transferase, increase in bilirubin conjugate, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital tract bleeding, hematuria, menorrhagia, kidney dysfunction, increase in serum creatinine, increase in serum urea, nasal bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, myocardial infarction, arthralgia, deep vein thrombosis, facial flushing, congestive heart failure, urinary tract infection, pseudomembranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulcer, high fever, severe dysphagia, angina, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, bowel motility disorder, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, voiding disorders, nephrolithiasis, bladder carcinoma, prostatic hyperplasia, influenza-like syndrome, drug hypersensitivity reaction, Stevens-Johnson syndrome, syncope, drowsiness

This medication should be stored in a sealed container to protect it from air and moisture, and it is best to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

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