Rivaroxaban 10 mg Tablets (Rivaroxaban)

Adult dosage

This medicine 10 mg may be taken with or without food; 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 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 in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement and have received 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 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 of treatment and dose should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism against 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 Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence, 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 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 is 10 mg once daily. The initial 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; 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. 4) If you miss a dose Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at one time. Starting the next day, continue taking 15 mg twice daily. Patients 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 must not be doubled to make up for a missed dose. For the reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation who have moderate renal impairment (creatinine clearance 30-49 mL/min) or severe renal impairment (creatinine clearance 15-29 mL/min), the recommended dose is 15 mg once daily. No dosage adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min) for treatment of deep vein thrombosis and pulmonary embolism/reduction of recurrence risk or for prevention of venous thromboembolism in adults undergoing major orthopedic surgery of the lower limbs (knee or hip replacement). No dosage adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Use with caution in patients with severe renal impairment (creatinine clearance 15-29 mL/min). Administration is not recommended in patients with severe renal impairment and creatinine clearance <15 mL/min. For patients unable to swallow tablets, this medicine may be crushed immediately before use and mixed with water or a beverage such as applesauce for oral administration. It may also be crushed and administered through a gastrointestinal tube with a small amount of water.

This medicine is an anticoagulant that prevents blood clotting. During treatment, bleeding may occur, so signs of bleeding should be carefully monitored. If severe bleeding occurs, immediately stop taking this medicine and consult a doctor. Patients with a known allergy to this medicine, severe bleeding, significantly impaired liver function, pregnant or nursing women should not take this product. Additionally, patients with a recent history of gastrointestinal ulcers or intracranial hemorrhages, blood coagulation disorders, or certain diseases with a high risk of bleeding should also not use this medication. When used with other anticoagulants, the risk of bleeding significantly increases, so co-administration should be avoided. Patients with impaired kidney function or high bleeding risk, and those taking certain medications should use this medicine with caution. Taking this medication with non-steroidal anti-inflammatory drugs, platelet inhibitors, or certain antidepressants may increase the risk of bleeding, so caution is needed. This medication may cause various side effects, including bleeding, anemia, gastrointestinal disorders, skin rashes, etc. In particular, if severe bleeding or serious skin rashes occur, immediate medical attention is required. It should not be taken during pregnancy as it may pose risks to the fetus, and women of childbearing age should ensure contraceptive measures while taking this medication. Elderly patients may be at a higher risk of bleeding, but special dosage adjustments are not necessary. Safety and efficacy have not been established for children or adolescents under 18 years of age, so its use is not recommended. In the event of overdose, the risk of bleeding significantly increases, and immediate medical treatment should be sought. Furthermore, this medication may cause drowsiness or dizziness during driving or operating machinery, so caution is required. Before surgery or invasive procedures, this medication should be discontinued for a certain period, and after procedures, resumption should be based on doctor’s advice considering the risk of bleeding. When taken with certain antifungal, antiviral, or antibiotic agents, the concentration of this medication may increase and the risk of bleeding may heighten, so co-administration should be discussed with a healthcare professional. During the course of taking this medication, if symptoms or adverse reactions such as bleeding appear, immediately inform healthcare professionals and take appropriate action.

• Hemorrhage
• anemia
• thrombocytosis
• tachycardia
• ocular hemorrhage
• gingival bleeding
• gastrointestinal tract bleeding
• abdominal pain
• dyspepsia
• nausea

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP packaging x 3)]