Rivaroxaban 10 mg tablets

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 in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement and have been treated with rivaroxaban 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] in combination with a P2Y12 inhibitor for up to 12 months. 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 following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism in relation to 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 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. ① Patients 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. ② Patients 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 ① Reduction 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. ② Treatment 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, 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 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, and thereafter administer the vitamin K antagonist dose according to INR test results. However, in patients receiving this medicine together with a vitamin K antagonist, 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 at the time the 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 with a creatinine clearance of 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood levels 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 a creatinine clearance of 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 administering this medicine to patients with liver disease associated with coagulopathy and 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 and mixed with water or a beverage such as 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 correctly positioned and flush the tube with water after administration.

This medication is used to inhibit the action of blood coagulation, preventing or treating thrombus formation. During treatment, careful observation for bleeding symptoms is necessary, particularly in patients at high risk for bleeding. If serious bleeding occurs, discontinue use immediately and seek treatment under medical direction. This drug does not require routine concentration monitoring with specific blood tests; however, blood concentration testing may be helpful in emergencies. It should not be used in patients with allergies to this drug’s active or inactive components, serious bleeding, significantly impaired liver function, or in pregnant or breastfeeding women. Additionally, patients with genetic metabolic disorders, such as lactose intolerance, should not take this medication. Patients with a recent history of gastrointestinal ulcers, history of intracranial hemorrhage, certain vascular abnormalities, or malignancies that increase the bleeding risk should also avoid this drug. There may be an increased risk of bleeding when used in conjunction with other anticoagulants or certain antifungals, so caution and consultation with a physician are advised. Patients with impaired renal function or conditions with a high risk of bleeding must exercise extra caution when using this medication, and the bleeding risk versus therapeutic benefit should be carefully assessed. Concomitant use with NSAIDs, antiplatelet agents, or selective serotonin reuptake inhibitors may increase the risk of bleeding, necessitating caution. Various side effects have been reported, with the most common being bleeding-related symptoms, and may include anemia, gastrointestinal symptoms, and skin rashes. Serious adverse reactions such as severe skin reactions or agranulocytosis may occur, so any unusual symptoms should be reported to healthcare personnel immediately. In elderly patients, drug concentrations may increase due to renal function decline; however, dosage adjustment is generally not necessary, although the risk of bleeding may be heightened. Pregnant women should avoid taking this medication as it may pose risks to the fetus, and women of childbearing age should take necessary contraception during treatment. In cases of overdose, the risk of bleeding increases, thus immediate medical attention is required. Prior to surgery or invasive procedures, this medication should be discontinued for a designated period, and special precautions are needed during neuraxial anesthesia due to the risk of severe nerve damage from bleeding. Caution is also advised while driving or operating machinery due to the risk of drowsiness or fainting.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, digestive disorders, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy depletion, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound discharge, vascular pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urinary and reproductive tract bleeding, kidney dysfunction, epistaxis, hemoptysis, itching, rash, petechial hemorrhage, cutaneous and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reaction with systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, deep vein thrombosis, arthralgia, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, influenza-like symptoms, drug hypersensitivity reaction, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, intestinal motility disorders, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, micturition disorders, kidney stones, bladder carcinoma, prostatic hyperplasia, Stevens-Johnson syndrome, syncope, drowsiness

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, in a recommended temperature range from 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer period.

Appearance

Bright red round film-coated tablet.

Package unit

30 tablets/box [10 tablets/PTP X 3]