Xarelta 10
Form: Tablet
Strength: 10mg
Generic Name: Rivaroxaban
Company: Opsonin Pharma Limited
MRP:৳ 25.0 (Tablet)
Is Antibiotic: No
Indications
Xarelta 10 is used to prevent atherothrombotic events in adults after an Acute Coronary Syndrome (ACS) with high cardiac biomarkers (Troponin or CK-MB). Xarelta 10 is taken with Aspirin alone or with Aspirin and Clopidogrel or Ticlopidine.
Xarelta 10 is also used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Xarelta 10 helps treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and reduces the risk of recurrence of these conditions.
Xarelta 10 is used to prevent DVT in patients undergoing knee or hip replacement surgery, which could lead to PE.
Pharmacology
Xarelta 10 is a selective direct factor Xa inhibitor. By inhibiting factor Xa, Xarelta 10 interrupts the blood coagulation process and prevents the formation of thrombin. Xarelta 10 does not affect thrombin (activated factor II), and no effects on platelets have been shown.
Dosage & Administration
Rivaroxaban 2.5 mg: The recommended dose is 2.5 mg twice daily. Xarelta 10 should be taken with a daily dose of 75-100 mg of Aspirin, or Aspirin with either 75 mg of Clopidogrel or the standard dose of Ticlopidine.
Rivaroxaban 10-20 mg: For nonvalvular atrial fibrillation, for patients with Creatinine Clearance >50 mL/min: 20 mg once daily with the evening meal. For Creatinine Clearance 15-50 mL/min: 15 mg once daily with the evening meal.
For DVT & PE treatment: Take 15 mg twice daily with food for the first 21 days, then 20 mg once daily with food for the remaining treatment.
To prevent recurrence of DVT and PE: 20 mg once daily with food.
For DVT prevention after hip surgery: 10 mg once daily for 35 days.
For DVT prevention after knee surgery: 10 mg once daily for 12 days.
Xarelta 10 can be taken with or without food.
Interaction
Using Rivaroxaban with drugs that are both P-gp and CYP3A4 inhibitors (like ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, and dronedarone) can increase its effects and should be avoided. Also, combining Rivaroxaban with strong CYP3A4 inducers (like rifampicin, phenytoin, carbamazepine) may reduce its effectiveness and should be avoided.
Taking other medications like anti-platelet drugs, heparin, fibrinolytic therapy, or NSAIDs may increase the risk of bleeding.
Contraindications
Xarelta 10 should not be used in patients with known hypersensitivity to Rivaroxaban or any of its components, or in those with active pathological bleeding.
Side Effects
The most common side effects include increased risk of bleeding, spinal or epidural hematoma, and increased stroke risk after discontinuation, particularly in patients with nonvalvular atrial fibrillation.
Pregnancy & Lactation
Xarelta 10 is a pregnancy category C drug. There are no well-controlled studies in pregnant women, and dosing for pregnant women has not been established. Xarelta 10 is unknown whether Rivaroxaban is excreted in breast milk. The safety and effectiveness of Rivaroxaban in breastfeeding women have not been established.
Precautions & Warnings
Discontinuing Rivaroxaban early, without alternative anticoagulation, increases the risk of blood clots. Xarelta 10 also increases the risk of bleeding, especially in patients with certain risk factors like bleeding disorders, uncontrolled high blood pressure, gastrointestinal diseases (like inflammatory bowel disease, esophagitis, gastritis, or gastroesophageal reflux disease), and vascular retinopathy. Symptoms of neurological impairment should be closely monitored, especially in patients undergoing spinal/epidural anesthesia or spinal puncture, as spinal or epidural hematoma can occur. Rivaroxaban is not recommended for patients with pulmonary embolism who are unstable or may need thrombolysis or pulmonary embolectomy.
Overdose Effects
Overdose may cause bleeding. Rivaroxaban’s absorption does not increase with single doses greater than 50 mg. There is no specific antidote available. Activated charcoal may be used to reduce absorption in case of overdose. Partial reversal of anticoagulation can be achieved with plasma products.
Therapeutic Class
Oral Anti-coagulants
Storage Conditions
Store in a cool (below 30°C) and dry place, away from light. Keep out of reach of children.
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|---|---|---|---|---|
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