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 orTidopidine.

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

Therapeutic Class

Oral Anti-coagulants

Pharmacology

Rivaroxaban is a highly selective direct factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibits thrombin formation. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.

Dosage

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

Administration

May be taken with or without food.

Interaction

CYP3A4, P-GP inhibitors and NSAIDs.

Contraindications

Active pathological bleeding & severe hypersensitivity reaction to Rivaroxaban

Side Effects

The most common adverse reaction is bleeding. Increased risk of stroke after discontinuation in nonvalvular atrial fibrillation.

Pregnancy & Lactation

There are no adequate or well-controlled studies of Rivaroxaban in pregnant women, and dosing for pregnant women has not been established.

Safety and efficacy of Rivaroxaban have not been established in breast-feeding women

Precautions & Warnings

Rivaroxaban can cause bleeding. Promptly evaluate signs and symptoms of blood loss. Rivaroxaban use not recommended in case of Prosthetic heart valves.

Storage Conditions

Protect from light, store below 30° C. Keep out of reach of children.