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Xarelta 2.5

Form: Tablet

Strength: 2.5mg

Generic Name: Rivaroxaban

Company: Opsonin Pharma Limited

MRP:৳ 8.0   (Tablet)

Is Antibiotic: No

Indications

Xarelta 2.5 is used to prevent atherothrombotic events in adults after an Acute Coronary Syndrome (ACS) with high cardiac biomarkers (Troponin or CK-MB). Xarelta 2.5 is taken with Aspirin alone or with Aspirin and Clopidogrel or Ticlopidine.

Xarelta 2.5 is also used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Xarelta 2.5 helps treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and reduces the risk of recurrence of these conditions.

Xarelta 2.5 is used to prevent DVT in patients undergoing knee or hip replacement surgery, which could lead to PE.

Pharmacology

Xarelta 2.5 is a selective direct factor Xa inhibitor. By inhibiting factor Xa, Xarelta 2.5 interrupts the blood coagulation process and prevents the formation of thrombin. Xarelta 2.5 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 2.5 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 2.5 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 2.5 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 2.5 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 2.5 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 2.5 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.

Similar Brands of Rivaroxaban (Tablet – 2.5mg)

Brand Name Form Strength Company MRP (৳)
Rafter 2.5 Tablet 2.5mg Healthcare Pharmaceuticals Ltd. 8.0
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Rivarox 2.5 Tablet 2.5mg Eskayef Pharmaceuticals Ltd. 8.0
RivaXa 2.5 Tablet 2.5mg Square Pharmaceuticals Ltd. 8.0
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