Rovaclot

Strengths

Rovaclot 2.5, Rovaclot 10, Rovaclot 15, Rovaclot 20

Dosage Form

Film Coated Tablets

Composition

Rovaclot 2.5
Each film coated tablet contains:
Rivaroxaban 2.5 mg

Rovaclot 10
Each film coated tablet contains:
Rivaroxaban 10 mg

Rovaclot 15
Each film coated tablet contains:
Rivaroxaban 15 mg

Rovaclot 20
Each film coated tablet contains:
Rivaroxaban 20 mg

Packaging

Rovaclot 2.5: 10 or 30 film coated tablets
Rovaclot 10: 10 or 30 film coated tablets
Rovaclot 15: 10 or 30 film coated tablets
Rovaclot 20: 10 or 30 film coated tablets

Indications

• Is used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
• Is indicated for the treatment of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery.
• Is indicated for the treatment of Pulmonary Embolism (P.E.).
• Is indicated for reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism following initial 6 months treatment for DVT and/or PE.
• Is indicated for the prophylaxis of Deep Vein Thrombosis (DVT) following Hip or Knee replacement surgery, which may lead to Pulmonary Embolism (PE).
• Reduction of Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD) (for 2.5 mg strength).

Dosage and Administration

Reduction in risk of stroke in Nonvalvular Atrial Fibrillation:
Patients with creatinine clearance (CrCl > 50 ml/min); one tablet of 20 mg once daily with the evening meal.
Patients with (CrCl 15 to 50 mL /min); one tablet of 15 mg once daily with the evening meal.
Treatment of Deep Vein Thrombosis (DVT):
One tablet of 15 mg twice daily with food for first 21 days, after 21 days, transition to 20 mg once daily with food for remaining treatment.
Treatment of Pulmonary Embolism (PE):
One tablet of 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/or PE in patients at continued risk for DVT and/or PE:
10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment. at approximately the same time each day.
Prophylaxis of DVT following Hip or Knee replacement surgery:
- Hip replacement: one tablet of 10 mg once daily for 35 days, with or without food. The initial dose should be taken 6 to 10 hours after surgery provided that haemostasis has been established
- Knee replacement: one tablet of 10 mg once daily for 12 days, with or without food. The initial dose should be taken 6 to 10 hours after surgery provided that haemostasis has been established.
Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in Chronic CAD or PAD:
 No dose adjustment needed based on CrCl. 2.5 mg twice daily, plus aspirin (75–100 mg) once daily. Take with or without food.
Important food effect information:
The 15 mg and 20 mg tablets should be taken with food, while the 2.5 mg or 10 mg tablets can be taken with or without food, In the nonvalvular atrial fibrillation efficacy study it was taken with the evening meal.
Switching to and from Rivaroxaban to other anticoagulant:
-Switching from warfarin to Rivaroxaban: When switching patients from warfarin to Rivaroxaban discontinue warfarin and start Rivaroxaban as soon as the International Normalized Ratio (INR) is below 3.0 to avoid periods of inadequate anticoagulation.
- Switching from Rivaroxaban to warfarin: No clinical trial data are available to guide