Rivaroxaban 2.5 mg:

• For the prevention of atherothrombotic events in adult patients after an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (Troponin or CK-MB). It is co-administered with aspirin alone or with aspirin plus clopidogrel or ticlopidine.

Rivaroxaban 10-20 mg:

• To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
• For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and reduction in the risk of recurrence of DVT and PE
• For the prophylaxis of DVT, which may lead to PE, in patients undergoing knee or hip replacement sur

Rivaroxaban is a highly selective direct factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade and inhibits thrombin formation. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.

Rivaroxaban 2.5 mg:

• Recommended dose: 2.5 mg twice daily. Patients should also take a daily dose of 75-100 mg aspirin or a daily dose of 75-100 mg aspirin in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.

Rivaroxaban 10-20 mg:

• Nonvalvular Atrial Fibrillation: For patients with creatinine clearance >50 mL/min: 20 mg orally, once daily with the evening meal.For patients with creatinine clearance 15-50 mL/min: 15 mg orally, once daily with the evening meal.
• Treatment of DVT & PE: For the first 21 days: 15 mg orally twice daily with food for the initial treatment of acute DVT or PE.After the initial treatment period, 20 mg orally once daily with food for the remaining treatment.
• Prevention in the Risk of Recurrence of DVT and PE: 20 mg once daily with food.
• Prophylaxis of DVT Following Hip Replacement Surgery: 10 mg once daily for 35 days.
• Prophylaxis of DVT Following Knee Replacement Surgery:10 mg once daily for 12 days.

May be taken with or without food.

Concomitant use with drugs that are combined P-gp and CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, dronedarone) increases rivaroxaban exposure and pharmacodynamic effects (i.e., factor Xa inhibition and PT prolongation); therefore, this should be avoided. Coadministration of rivaroxaban with a combined P-gp and strong CYP3A4 inducer (e.g., rifampicin, phenytoin, carbamazepine) decreases the efficacy of rivaroxaban and should also be avoided. The concomitant use of other drugs like antiplatelet agents, heparin, fibrinolytic therapy, and NSAIDs may cause an increased risk of bleeding.

It is contraindicated in patients with known hypersensitivity to rivaroxaban or any of the excipients of the product. It is also contraindicated in patients with active pathological bleeding.

The most common side effects of rivaroxaban include increased chance of bleeding, spinal or epidural hematoma, and increased risk of stroke after discontinuation in nonvalvular atrial fibrillation.

Rivaroxaban is a pregnancy category C drug. There are no adequate or well-controlled studies of rivaroxaban in pregnant women, and dosing for pregnant women has not been established. It is not known if rivaroxaban is excreted in human milk. The safety and efficacy of rivaroxaban has not been established in breastfeeding women.

Early discontinuation of Rivaroxaban without adequate alternative anticoagulation increases the risk of thrombotic events. Rivaroxaban also increases the risk of bleeding, which may be fatal, especially in patients with bleeding disorders, severe uncontrolled hypertension, gastrointestinal conditions (such as inflammatory bowel disease, esophagitis, gastritis, or gastroesophageal reflux disease), vascular retinopathy, bronchiectasis, or a history of pulmonary bleeding.Patients receiving neuraxial anesthesia (spinal/epidural) or undergoing spinal puncture should be closely monitored for neurological symptoms due to the risk of epidural or spinal hematoma. Rivaroxaban is not recommended in patients with pulmonary embolism who have hemodynamic instability or who may require thrombolysis or pulmonary embolectomy.

Overdose of rivaroxaban may lead to hemorrhage. Rivaroxaban systemic exposure is not further increased at single doses above 50 mg due to limited absorption. A specific antidote for rivaroxaban is not available. The use of activated charcoal to reduce absorption in case of rivaroxaban overdose may be considered. Partial reversal of laboratory anticoagulation parameters may be achieved with the use of plasma products.

Oral Anti-coagulants

Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.