Rivaroxaban 10 mg Tablets (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. 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 coadministration 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. 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 treatment dose should be determined following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative 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, total daily dose 30mg. From day 22: 20mg once daily, total daily dose 20mg. Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism: After at least 6 months of treatment, 10mg once daily, total daily dose 10mg. The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter during the treatment period. 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 established. The duration of treatment depends on the individual 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. If you forget to take this medicine: Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at one time. From the following day, continue taking 15 mg twice daily. 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 must not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this medicine: For reduction 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. For treatment 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. After taking this medicine, INR values will be falsely elevated regardless of the dose. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medicine. Switching from this medicine to a vitamin K antagonist: Patients switching from this medicine to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until the INR is ≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer a dose of the vitamin K antagonist based on INR testing. In patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this medicine. If this medicine is discontinued, INR testing may be performed 24 hours after the last dose. Switching from a parenteral anticoagulant to this medicine: 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 of discontinuation of a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 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. 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 plasma concentrations of this medicine increased significantly; therefore, this medicine should be administered with caution. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min, as there is no clinical experience in these patients. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose in 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. 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). 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. Patients unable to 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 drug is used to prevent or treat thrombus formation by preventing excessive blood clotting. While taking this medication, careful observation for signs of bleeding should be conducted, and patients at high risk of bleeding should be specially cautioned. In the event of severe bleeding, this medication should be discontinued, and appropriate treatment to control bleeding should be administered if necessary. This medication should not be administered to patients with certain diseases or conditions, such as those with severe bleeding, severe liver dysfunction, pregnant or breastfeeding women, and lactose intolerant patients. Patients with high bleeding risk conditions or those taking other anticoagulants or antiplatelet agents should be administered this medication more cautiously. In patients with impaired kidney function, the blood concentration of this medication may increase, raising the risk of bleeding, thus caution is needed. During the course of taking this medication, regular checks for bleeding symptoms or anemia symptoms should be conducted, and if unusual symptoms arise, immediate consultation with medical personnel is necessary. Particularly in patients receiving neuraxial procedures such as neuraxial anesthesia or spinal taps, caution is needed due to the risk of serious neurological damage from bleeding. This medication can interact with specific antifungal or antiviral agents, increasing blood concentrations, so if these medications are currently being taken, it is essential to inform a doctor or pharmacist and exercise caution. Pregnant or breastfeeding women should not take this medication, and fertile women must use contraception during treatment. Elderly patients may have an increased blood concentration of this medication due to reduced kidney function, but no separate dosage adjustment is necessary; however, the risk of bleeding may be increased. Overdosage may heighten the risk of bleeding, thus the dosage must be strictly followed, and if overdose is suspected, immediate medical attention should be sought. Caution is necessary when driving or operating machinery as drowsiness or dizziness may occur while taking this medication. This medication is not recommended for children and adolescents as its safety and efficacy are not established. If surgery or invasive procedures are planned, this medication should be discontinued before the procedure, and once the risk of bleeding is reduced post-procedure, it can be restarted. Suddenly discontinuing this medication may increase the risk of thrombosis, thus consultation with medical personnel for appropriate alternative treatment is necessary before cessation.

Bleeding, anemia, thrombocytosis, tachycardia, ocular bleeding, gingival bleeding, gastrointestinal bleeding, abdominal pain, abdominal discomfort, indigestion, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, systemic reduction of strength and energy, discomfort, local edema, liver dysfunction, jaundice, allergic reaction, allergic dermatitis, post-treatment bleeding, bruising, wound secretion, vascular pseudoaneurysm, transaminase increase, increased serum bilirubin, increased alkaline phosphatase, LDH increase, lipase increase, amylase increase, enzyme increase, bilirubin aggregate increase, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial and cerebral bleeding, fainting, urogenital bleeding, renal dysfunction, non-bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reaction, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stool, melena, deep vein thrombosis, arthralgia, unspecified bleeding, myocardial infarction, facial flushing, congestive heart failure, urinary tract infection, pseudomembranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulcer, high fever, severe dysphagia, cardiac ischemic symptoms, influenza-like symptoms, drug hypersensitivity reaction

This medication should be stored in a sealed container to protect it from air and moisture, and the temperature should be maintained between 1 degree and 30 degrees Celsius. Storing in this manner can help maintain the efficacy of the medication for a longer period.

Appearance

Bright red, round film-coated tablets

Package unit

100 tablets (10 tablets in PTP packaging x 10)