Rivolas Tablets (Rivaroxaban)

• Composition :
  Each tablet contains- Rivaroxaban 2.5mg/ 10mg/ 15mg / 20mg.
• Indications :
  Rivaroxaban 2.5 mg tablet, co-administered with Acetylsalicylic acid (ASA) alone or with ASA plus Clopidogrel or Ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Rivaroxaban 10 mg: For the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Rivaroxaban 15/20 mg: Treatment of deep vein thrombosis and for prevention of recurrent DVT and pulmonary embolism. For the prevention of stroke and systemic embolism in patient with non-valvular arterial fibrillation.
• Pharmacodynamics :
  Rivaroxaban is an orally bioavailable factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. Activation of factor X to factor Xa (FXa) via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation
• Dosage and administration :
  Nonvalvular Atrial Fibrillation: 15 or 20 mg, once daily with food. Treatment of DVT and/or PE: 15 mg orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food for the 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. Prophylaxis of DVT Following Hip or Knee Replacement Surgery: 10 mg orally once daily with or without food. Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding: 10 mg once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days. ACS: 2.5 mg orally twice daily with or without food, in combination with aspirin (75-100 mg) once daily
• Contraindications :
  Active pathological bleeding, severe hypersensitivity reaction to rivaroxaban, severe renal insufficiency.
• Precautions and warnings :
  Rivaroxaban can cause serious and fatal bleeding. Premature discontinuation of rivaroxaban, can increase the risk of thrombotic events - coverage with any other anticoagulant should be condisered. Use of rivaroxaban in patients with prosthetic heart valves in not recommended.
• Use in pregnancy, lactation & pediatrics :
  There are no well-established studies regarding the use of rivaroxaban in human pregnancy and lactation. However, use in pregnancy should be avoided due to the risk of obstetric haemorrhage. Safety and efficacy of Rivaroxaban use in pediatric patients have not been established.
• Drug interactions :
  Avoid combined P-gp and strong CYP3A inhibitors (e.g. ketoconazole, ritonavir and erythromycin) and inducers (e.g. carbamazepine, phenytoin and rifampin). Avoid concomitant use with other anticoagulants.
• Adverse reactions :
  The most common adverse effects of rivaroxaban is bleeding.
• Therapy Area :
  Anti-Coagulants