Nurox Tablet 10 mg (Rivaroxaban)

Adult dose

This 10 mg medicine may be taken with or without food, while the 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 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 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. 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, is 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 individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment period / Administration frequency / 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 during the subsequent 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 first dose should be administered 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. 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. 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 one tablet once daily. The daily dose must 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, INR values 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 when switching to another anticoagulant. Be aware that this medicine may affect INR elevation. 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, and thereafter administer the dose determined by 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 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 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 required 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 plasma concentrations 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 below 15 mL/min, as there is no clinical experience in this population. 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 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 who cannot swallow tablets, Immediately before use, this medicine may be crushed, mixed with water or a beverage such as 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 properly positioned and flush the tube with water after administration.

This medication prevents the formation of blood clots by inhibiting blood coagulation. During treatment, bleeding may occur, so it is important to carefully monitor for symptoms of bleeding. If severe bleeding occurs, the medication should be discontinued immediately and a doctor should be consulted. This medication should not be administered to patients with certain diseases or conditions. For example, patients with severe bleeding, severe liver dysfunction, pregnant or breastfeeding women, and those with lactose intolerance should not take this medication. Additionally, patients with recent gastrointestinal ulcers or history of intracranial bleeding, as well as those with vascular anomalies or malignancies should be cautious. When taken with other anticoagulants or certain antifungal agents, the risk of bleeding may increase, so it is essential to inform the doctor. Patients with impaired renal function or diseases with a high risk of bleeding should use this medication cautiously and be more vigilant for bleeding symptoms. During treatment, both signs of bleeding and symptoms of anemia should be monitored, and blood tests to check for bleeding may be helpful. Should bleeding occur, the dosing regimen may be adjusted, or treatment may be temporarily discontinued, and if necessary, treatment to stop the bleeding should be administered. This medication may cause various side effects such as skin rash, allergic reactions, liver dysfunction, and blood abnormalities in some patients; thus, immediate consultation with healthcare professionals is necessary if any unusual symptoms arise. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should ensure to use contraception while on this medication. Elderly patients may experience increased drug concentration due to decreased renal function, but usually no separate dose adjustment is necessary, however, the risk of bleeding may increase. It is not recommended for pediatric and adolescent patients under 18 years as safety and efficacy have not been established. Overdose significantly increases the risk of bleeding, hence it is essential to adhere to the prescribed dosage, and if overdose is suspected, immediate hospital visit is necessary. Caution is advised when driving or operating machinery, as drowsiness or dizziness may occur. Before and after taking this medication, it is crucial to inform the healthcare professional about any surgical or invasive procedures, and adjust the duration of discontinuation if necessary. This medication affects blood coagulation, therefore consulting with a doctor or pharmacist regarding potential drug interactions is important.

Hemorrhage, anemia, thrombocytosis, tachycardia, eye hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, indigestion, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy reduction, discomfort, local edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, bleeding after treatment, bruising, wound secretion, vascular pseudoaneurysm, transaminase elevation, increased 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 and cerebral hemorrhage, syncope, urogenital bleeding, hematuria, menorrhagia, renal impairment, increased blood creatinine, increased blood urea, non-bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions associated with systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine bleeding, deep vein thrombosis, arthralgia, unspecified hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, melena, tarry stools, myocardial infarction, facial flushing, Pseudomonas aeruginosa wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, influenza-like syndrome, drug hypersensitivity reaction

This medication should be kept in a tightly closed container to prevent exposure to air or moisture, and the storage temperature should be maintained between 1 and 30 degrees Celsius to preserve efficacy.

Appearance

Bright red circular film-coated tablet

Package unit

30 tablets/PTP [30 tablets (10 tablets/PTP packaging X3)]