Roxarel 10: Each Tablet contains Rivaroxaban INN 10 mg.
Roxarel 15: Each Tablet contains Rivaroxaban INN 15 mg.
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
- For the prophylaxis of DVT, in patients undergoing knee or hip replacement surgery.
- Treatment of DVT and PE: 15 mg twice daily with food, for first 21 days. After 21 days, transition to 20 mg once daily with food, for remaining treatment.
Reduction in the risk of recurrence of DVT and PE: 20 mg once daily with food.
When converting patients from warfarin therapy to rivaroxaban, discontinue warfarin and start rivaroxaban when the INR is below 3.0.
In case of converting from rivaroxaban to warfarin, no clinical trial data are available for proper guidence. One approach is to discontinue rivaroxaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of rivaroxaban would have been taken.
Converting from or to Anticoagulants other than Warfarin
For patients currently taking rivaroxaban and transitioning to an anticoagulant with rapid onset, discontinue rivaroxaban and give the first dose of the other anticoagulant (oral or parenteral) at the time that the next rivaroxaban dose would have been taken.
For patients currently receiving an anticoagulant other than warfarin, start rivaroxaban 0 to 2 hours prior to the next scheduled evening administration of the drug (e.g., low molecular weight heparin or non-warfarin oral anticoagulant) and omit administration of the other anticoagulant. For unfractionated heparin being administered by continuous infusion, stop the infusion and start rivaroxaban at the same time
Discontinuation for Surgery and Other Interventions
If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, rivaroxaban should be stopped at least 24 hours before the procedure. rivaroxaban should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established. If oral medication cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant.
Prophylaxis of DVT Following Hip or Knee Replacement Surgery: For hip replacement: 10 mg once daily for 35 days; for knee replacement: 10 mg once daily for 12 days.
There are no adequate and well-controlled studies in pregnant women.
Lactation: Safety and efficacy of Rivaroxaban have not been established in breast feeding women. A decision must be made whether to discontinue breast feeding or to discontinue/abstain from therapy.
Safety and effectiveness of Rivaroxaban in pediatric patients have not been established.
Roxarel 15: Each box contains blister strips of 10 tablets
The risk of thrombotic and bleeding events increases with age, but the risk-benefit profile is favorable in all age groups.
Nonvalvular Atrial Fibrillation: Avoid the use of rivaroxaban in patients with CrCl <15 mL/min. Periodically assess renal function as clinically indicated. Discontinue rivaroxaban in patients who develop acute renal failure while on rivaroxaban.
Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Reduction in the Risk of Recurrence of DVT and of PE and Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery: Avoid the use of rivaroxaban in patients with CrCl <30 mL/min.