Product Description

Indications: Rivarox is indicated for prevention and treatment of thromboembolic disorders. Rivarox 2.5 mg is used to prevent atherothrombotic events in adults after acute coronary syndrome (ACS) with elevated cardiac biomarkers and is administered with aspirin alone or with aspirin plus clopidogrel/ticlopidine. Rivarox 10-20 mg is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, for treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for prophylaxis of DVT after knee or hip replacement surgery.Pharmacology: Rivaroxaban is a highly selective direct Factor Xa inhibitor. By blocking Factor Xa, it interrupts both intrinsic and extrinsic coagulation pathways, reducing thrombin formation and clot development. It does not directly inhibit thrombin and has no significant effect on platelets.Dosage & Administration:Rivarox 2.5 mg: Recommended dose is 2.5 mg twice daily along with aspirin 75-100 mg daily, with or without clopidogrel or ticlopidine as prescribed.Non-valvular atrial fibrillation:Creatinine clearance >50 mL/min: 20 mg once daily with evening meal.Creatinine clearance 15-50 mL/min: 15 mg once daily with evening meal.Treatment of DVT & PE: 15 mg twice daily with food for the first 21 days, followed by 20 mg once daily with food.Prevention of recurrent DVT & PE: 20 mg once daily with food.DVT prophylaxis after surgery:Hip replacement: 10 mg once daily for 35 days.Knee replacement: 10 mg once daily for 12 days.May be taken with or without food depending on dose and indication.Interaction: Concomitant use with strong CYP3A4 and P-gp inhibitors such as ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, verapamil, diltiazem, and dronedarone may increase bleeding risk and should generally be avoided. Strong CYP3A4 inducers like rifampicin, phenytoin, and carbamazepine may reduce efficacy. Concurrent use with NSAIDs, antiplatelets, heparin, or fibrinolytics may further increase bleeding risk.Contraindications: Contraindicated in patients with hypersensitivity to rivaroxaban or any component of the formulation and in patients with active pathological bleeding.Side Effects: Common adverse effects include bleeding complications, spinal or epidural hematoma, and increased risk of stroke after abrupt discontinuation in patients with non-valvular atrial fibrillation.Pregnancy & Lactation: Pregnancy Category C. Adequate studies in pregnant women are unavailable, so use during pregnancy only if clearly needed. It is unknown whether rivaroxaban is excreted in human milk; caution is advised during breastfeeding.Precautions & Warnings: Sudden discontinuation may increase the risk of thrombotic events. Use cautiously in patients with bleeding disorders, uncontrolled hypertension, gastrointestinal diseases, vascular retinopathy, bronchiectasis, or history of pulmonary bleeding. Patients receiving spinal or epidural anesthesia should be monitored for neurological symptoms due to risk of hematoma. Not recommended in hemodynamically unstable pulmonary embolism patients requiring thrombolysis or embolectomy.Overdose Effects: Overdose may result in hemorrhage. Activated charcoal may help reduce absorption if administered early. There is no specific antidote, although plasma products may partially reverse anticoagulant effects.Therapeutic Class: Oral anticoagulantsStorage Conditions: Store below 30°C in a cool and dry place, protected from light. Keep out of reach of children.