Rivaroxaban
Therapeutic Class: Cardiovascular (Oral Anticoagulants)
Indications:
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 Tidopidine.
Rivaroxaban 10-20 mg:
Presentation:
Rivaroxabanl 10: Each Tablet contains Rivaroxaban INN 10 mg.
Rivaroxaban 15: Each Tablet contains Rivaroxaban INN 15 mg.
Description:
Rivaroxaban is a selective inhibitor of clotting factor Xa (FXa). It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.
Side Effects:
Haemorrhage, nausea, vomiting, diarrhoea, constipation, dyspepsia, abdominal pain, hypotension, dizziness, headache, renal impairment, pain in extremity, fever, peripheral oedema, fatigue. Other less common side effects include thrombocythemia, allergic reaction, syncope, tachycardia, abnormal hepatic function.
Precautions:
Premature discontinuation of rivaroxaban, in the absence of adequate alternative anticoagulation, increases the risk of thrombotic events. Rivaroxaban increases the risk of bleeding that can be fatal in presence of the following risk factors- bleeding disorders, uncontrolled severe arterial hypertension, gastrointestinal disease (e.g., inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease), vascular retinopathy, bronchiectasis, history of pulmonary bleeding, Signs or symptoms of neurological impairment should be monitored in case of neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal puncture as epidural or spinal hematoma can occur. Rivaroxaban is not recommended in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category C.
There are no adequate and well-controlled studies on pregnant women.
Lactation: The safety and efficacy of Rivaroxaban have not been established in breastfeeding women. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy.
Pediatric Use:
The safety and effectiveness of Rivaroxaban in pediatric patients have not been established.
Interaction:
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) thus 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.
Overdose:
Overdose of rivaroxaban may lead to haemorrhage. Discontinue rivaroxaban and initiate appropriate therapy if bleeding complications associated with overdosage occur. 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.
Storage:
Store at 25°C; excursions permitted to 15°-30°C.
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 Tidopidine.
Rivaroxaban 10-20 mg:
To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
Deep vein thrombosis (DVT) & pulmonary embolism (PE) and reduction in the risk of recurrence of DVT and of PE For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
Deep vein thrombosis (DVT) & pulmonary embolism (PE) and reduction in the risk of recurrence of DVT and of PE For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
Presentation:
Rivaroxabanl 10: Each Tablet contains Rivaroxaban INN 10 mg.
Rivaroxaban 15: Each Tablet contains Rivaroxaban INN 15 mg.
Description:
Rivaroxaban is a selective inhibitor of clotting factor Xa (FXa). It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.
Dosage & Administration:
Rivaroxaban 2.5 mg: The recommended dose is 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 Creatinin Clearance >50 mL/min: 20 mg orally, once daily with the evening meal. For patients with Creatinin Clearance 15-50 ml/min: 15 mg orally, once daily with the evening meal
Rivaroxaban 2.5 mg: The recommended dose is 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 Creatinin Clearance >50 mL/min: 20 mg orally, once daily with the evening meal. For patients with Creatinin Clearance 15-50 ml/min: 15 mg orally, once daily with the evening meal
Treatment of DVT & PE: 15 mg orally twice daily with food for the first 21 days 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 of 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
Prevention in the risk of recurrence of DVT and of 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
Side Effects:
Haemorrhage, nausea, vomiting, diarrhoea, constipation, dyspepsia, abdominal pain, hypotension, dizziness, headache, renal impairment, pain in extremity, fever, peripheral oedema, fatigue. Other less common side effects include thrombocythemia, allergic reaction, syncope, tachycardia, abnormal hepatic function.
Precautions:
Premature discontinuation of rivaroxaban, in the absence of adequate alternative anticoagulation, increases the risk of thrombotic events. Rivaroxaban increases the risk of bleeding that can be fatal in presence of the following risk factors- bleeding disorders, uncontrolled severe arterial hypertension, gastrointestinal disease (e.g., inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease), vascular retinopathy, bronchiectasis, history of pulmonary bleeding, Signs or symptoms of neurological impairment should be monitored in case of neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal puncture as epidural or spinal hematoma can occur. Rivaroxaban is not recommended in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category C.
There are no adequate and well-controlled studies on pregnant women.
Lactation: The safety and efficacy of Rivaroxaban have not been established in breastfeeding women. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy.
Pediatric Use:
The safety and effectiveness of Rivaroxaban in pediatric patients have not been established.
Interaction:
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) thus 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.
Overdose:
Overdose of rivaroxaban may lead to haemorrhage. Discontinue rivaroxaban and initiate appropriate therapy if bleeding complications associated with overdosage occur. 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.
Storage:
Store at 25°C; excursions permitted to 15°-30°C.
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