Roxarel 10

Indications

Roxarel 2.5 mg

• Prevents atherothrombotic events in adult patients following an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (e.g., Troponin or CK-MB). Typically co-administered with Aspirin alone or alongside Aspirin plus Clopidogrel or Ticlopidine.

Roxarel 10-20 mg

• Reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
• Treats Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) and reduces the recurrence risk of both conditions.
• Prevents DVT in patients undergoing knee or hip replacement surgery, which could lead to PE.

Always use Roxarel under the guidance of a registered healthcare professional.

Pharmacology

Rivaroxaban is a highly selective direct Factor Xa inhibitor, which disrupts the intrinsic and extrinsic pathways of blood coagulation, inhibiting thrombin formation. Unlike other anticoagulants, Rivaroxaban does not inhibit thrombin (activated Factor II) and has no direct effects on platelet activity.

Dosage & Administration

Rivaroxaban 2.5 mg

• Recommended Dose: Take 2.5 mg twice daily.
• Combination Therapy: Also take 75-100 mg of Aspirin daily, or 75 mg Clopidogrel or a standard daily dose of Ticlopidine alongside Roxarel.

Rivaroxaban 10-20 mg

• Nonvalvular Atrial Fibrillation:
  • For Creatinine Clearance > 50 mL/min: Take 20 mg daily with the evening meal.
  • For Creatinine Clearance 15-50 mL/min: Take 15 mg daily with the evening meal.
• Treatment of DVT & PE:
  • Initial Treatment: Take 15 mg twice daily with food for the first 21 days.
  • Maintenance Treatment: After 21 days, take 20 mg once daily with food.
• Prevention of DVT & PE Recurrence: Take 20 mg once daily with food.
• Prophylaxis after Hip Replacement Surgery: Take 10 mg once daily for 35 days.
• Prophylaxis after Knee Replacement Surgery: Take 10 mg once daily for 12 days.

Roxarel can be taken with or without food.

Always follow the prescribed dosage as directed by your healthcare provider.

Drug Interactions

• Avoid Concomitant Use with P-gp and CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir, Clarithromycin, Diltiazem, etc.), as this can increase Roxarel’s exposure and effects.
• Avoid co-administration with P-gp and strong CYP3A4 inducers (e.g., Rifampicin, Phenytoin, Carbamazepine), which may reduce Roxarel’s efficacy.
• Use of antiplatelet agents, heparin, fibrinolytic therapy, or NSAIDs with Roxarel can increase the risk of bleeding.

Contraindications

• Roxarel is contraindicated in patients with a known hypersensitivity to Rivaroxaban or any of the product’s excipients.
• Should not be used in patients with active pathological bleeding.

Side Effects

Common side effects include an increased risk of bleeding, spinal or epidural hematoma, and stroke risk upon discontinuation in patients with nonvalvular atrial fibrillation.

Pregnancy & Lactation

• Pregnancy: Roxarel is classified as a Pregnancy Category C drug. Adequate studies in pregnant women are not available, and the safety of Rivaroxaban during pregnancy has not been established.
• Lactation: It is not known whether Rivaroxaban is excreted in human milk, and its safety and efficacy during breastfeeding have not been established.

Precautions & Warnings

• Early discontinuation of Roxarel without alternative anticoagulation may increase the risk of thrombotic events.
• Bleeding Risk: Roxarel increases bleeding risk, particularly in patients with:
  • Bleeding disorders
  • Uncontrolled hypertension
  • Gastrointestinal issues (e.g., inflammatory bowel disease, gastritis)
  • Vascular retinopathy, bronchiectasis, or history of pulmonary bleeding.
• Neuraxial Anesthesia: Special care should be taken when using spinal/epidural anesthesia or performing spinal puncture, as epidural or spinal hematoma may occur.
• Not recommended for patients with hemodynamic instability due to pulmonary embolism or those requiring thrombolysis or pulmonary embolectomy.

Overdose Effects

• Overdose of Roxarel may lead to hemorrhage.
• No specific antidote is available. Activated charcoal may be considered to reduce absorption.
• Plasma products can be used for partial reversal of anticoagulation.

Therapeutic Class

Oral Anticoagulants

Storage Conditions

Store Roxarel in a cool, dry place (below 30°C), away from light and out of the reach of children.