Rivarox 20 Tablet

Indications

Rivaroxaban 2.5 mg:

• For the prevention of atherothrombotic events in adult patients with increased cardiac biomarkers following an Acute Coronary Syndrome (ACS) (Troponin or CK-MB). It is used in combination with aspirin alone, aspirin + Clopidogrel, or Tidopidine.

Rivaroxaban 10-20 mg: 

• In individuals with nonvalvular atrial fibrillation, to minimize the risk of stroke and systemic embolism.
• Deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the risk of DVT and PE recurrence.
• In patients having knee or hip replacement surgery, for the prevention of DVT, which can progress to PE.

Pharmacology

Rivaroxaban is a direct factor Xa inhibitor with a high selectivity. Factor Xa inhibition reduces thrombin production by interrupting the intrinsic and extrinsic pathways of the blood coagulation cascade. Rivaroxaban has been shown to have no impact on platelets and does not block thrombin (activated factor II).

Dosage & Administration

Rivaroxaban 2.5 mg:

• The recommended dose: 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.

May be taken with or without food.

Interaction

Rivaroxaban exposure and pharmacodynamic effects (factor Xa inhibition and PT prolongation) are increased when used with medicines that are combination P-gp and CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, dronedarone). Rivaroxaban should not be used with a combination P-gp and strong CYP3A4 inducer (e.g., rifampicin, phenytoin, carbamazepine) since it reduces the effectiveness of Rivaroxaban. The use of anti-platelet medicines, heparin, fibrinolytic treatment, and NSAIDs at the same time may increase the risk of bleeding.

Contraindications

It is not recommended for patients who have a known hypersensitivity to Rivaroxaban or any of the product's excipients. It is also not recommended for individuals who are experiencing active pathological bleeding.

Side Effect

Increased risk of bleeding, spinal or epidural hematoma, and increased risk of stroke after cessation in nonvalvular atrial fibrillation are the most prevalent adverse effects of Rivaroxaban.

Pregnancy & Lactation

Rivaroxaban is classified as a pregnancy category C medication. Rivaroxaban has not been studied in pregnant women in sufficient or well-controlled trials, and dosage for pregnant women has not been established. Rivaroxaban is not known to be excreted in human milk. Rivaroxaban's safety and effectiveness in nursing mothers has yet to be determined.

Precautions & Warnings

In the absence of appropriate alternative anticoagulation, abruptly stopping Rivaroxaban increases the risk of thrombotic events. In the presence of the following risk factors, rivaroxaban increases the risk of bleeding, which can be fatal: bleeding disorders, uncontrolled severe arterial hypertension, gastrointestinal disease (e.g., inflammatory bowel disease, oesophagitis, gastritis, and gastroesophageal reflux disease), vascular retinopathy, bronchiectasis, and a history of pulmonary bleeding. In the event of neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture, signs or symptoms of neurological impairment should be observed since epidural or spinal hematoma can occur.

Therapeutic Class

Oral Anti-coagulants

Storage Conditions

Store in a cool (below 30°C) and dry location away from direct sunlight. Keep it out of children's reach.

Pharmaceutical Name

Eskayef Pharmaceuticals Ltd.