To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE).
Rivaroxaban is a highly selective direct factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibits thrombin formation. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.
Prophylaxis of venous thromboembolism following knee replacement surgery BY MOUTH Adult: 10 mg once daily for 2 weeks, to be started 6-10 hours after surgery Prophylaxis of venous thromboembolism following hip replacement surgery BY MOUTH Adult: 10 mg once daily for 5 weeks, to be started 6-10 hours after surgery Initial treatment of deep-vein thrombosis | Initial treatment of pulmonary embolism BY MOUTH Adult: Initially 15 mg twice daily for 21 days, to be taken with food Continued treatment of deep-vein thrombosis (following initial treatment) | Continued treatment of pulmonary embolism (following initial treatment) | Prophylaxis of recurrent deep-vein thrombosis | Prophylaxis of recurrent pulmonary embolism BY MOUTH Adult: 20 mg once daily, to be taken with food Prophylaxis of stroke and systemic embolism in patients with non-valvular atrial fibrillation and with at least one of the following risk factors: congestive heart failure, hypertension, previous stroke or transient ischaemic attack, age 75 years, or diabetes mellitus BY MOUTH Adult: 20 mg once daily, to be taken with food Prophylaxis of atherothrombotic events following an acute coronary syndrome with elevated cardiac biomarkers (in combination with aspirin alone or aspirin and clopidogrel) BY MOUTH Adult: 2.5 mg twice daily usual duration 12 months
Concomitant use with drugs that are combined P-gp and CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, dronedarone) increases in Rivaroxaban exposure and pharmacodynamic effects (i.e., factor Xa inhibition and PT prolongation), that’s why should be avoided. Co-administration of Rivaroxaban with a combined P-gp and strong CYP3A4 inducer (e.g., rifampicin, phenytoin, carbamazepine) decreases the efficacy of Rivaroxaban and also should be avoided. The concomitant use of other drugs like anti-platelet agents, heparin, fibrinolytic therapy, NSAIDs may cause an increased risk of bleeding.
Active bleeding . in acute coronary syndrome?previous stroke . in acute coronary syndrome? transient ischaemic attack . malignant neoplasms . oesophageal varices . recent brain surgery . recent gastrointestinal ulcer . recent intracranial haemorrhage . recent ophthalmic surgery . recent spine surgery . significant risk of major bleeding . vascular aneurysm. Anaesthesia with postoperative indwelling epidural catheter (risk of paralysis?monitor neurological signs and wait at least 18 hours after rivaroxaban dose before removing catheter and do not give next dose until at least 6 hours after catheter removal) . bronchiectasis . prosthetic heart valve (efficacy not established) . risk of bleeding . rivaroxaban should not be used as an alternative to unfractionated heparin in pulmonary embolism in patients with haemodynamic instability, or who may receive thrombolysis or pulmonary embolectomy . severe hypertension . vascular retinopathy.
Common or very common Abdominal pain . constipation . diarrhoea . dizziness . dyspepsia . haemorrhage . headache . hypotension . nausea . pain in extremities . pruritus . rash . renal impairment . vomiting Uncommon Angioedema . dry mouth . malaise . syncope . tachycardia . thrombocythaemia Rare Jaundice . oedema
PREGNANCY Manufacturer advises avoid?toxicity in animal studies. BREAST FEEDING Manufacturer advises avoid?present in milk in animal studies.
Overdose of Rivaroxaban may lead to hemorrhage. Rivaroxaban systemic exposure is not further increased at single doses >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 use of plasma products.
Store in a cool (below 30°C) & dry place protected from light. Keep away from the reach of children.
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