Xarelto Rivaroxaban Tablets

1. Indications and Usage
Prophylaxis of VTE: Indicated for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Treatment of VTE: Indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
2. Dosage and Administration
Orthopedic Surgery: The recommended dose is 10 mg once daily. The first dose should be administered 6-10 hours after surgery, once hemostasis is established. The course of treatment is 5 weeks for hip surgery and 2 weeks for knee surgery.
Treatment of DVT/PE: The initial treatment is 15 mg twice daily for the first 21 days, followed by 20 mg once daily for long-term treatment.
Administration: Can be taken with or without food.
3. Mechanism of Action
Direct Factor Xa Inhibitor: Rivaroxaban is an orally active, direct inhibitor of free and bound Factor Xa and Factor Xa in prothrombinase complex.
Anticoagulant Effect: By selectively inhibiting Factor Xa, it blocks both thrombin generation and thrombus formation, interrupting the coagulation cascade.
4. Safety and Warnings
Bleeding Risk: The most common risk is bleeding, which can be fatal. It is contraindicated in patients with clinically significant active bleeding.
Spinal/Epidural Hematoma: Spinal or epidural hematomas may occur in patients treated with rivaroxaban who receive neuraxial anesthesia or spinal puncture, potentially resulting in long-term or permanent paralysis.
Renal and Hepatic Impairment: Use is contraindicated in patients with severe renal impairment (CrCL <15 mL/min) or with hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include bleeding, anemia, nausea, and elevated liver enzymes.
Clinical Research: Pivotal Phase III studies have demonstrated that rivaroxaban is effective and safe for VTE prophylaxis in orthopedic surgery and for the treatment of DVT/PE, with a favorable bleeding profile compared to standard of care.
6. Drug Interactions
CYP3A4 and P-gp Inhibitors: Concomitant use with strong dual inhibitors (e.g., ketoconazole, ritonavir) significantly increases rivaroxaban exposure and bleeding risk; concomitant use is not recommended.
Anticoagulants and Antiplatelets: Concomitant use with other anticoagulants (e.g., heparins, warfarin) or antiplatelet agents (e.g., aspirin, clopidogrel) increases the bleeding risk and requires caution.
7. Pharmaceutical Information
Active Ingredient: Rivaroxaban.
Excipients: Lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate.
Appearance: Tablets (specific appearance and strength vary by market).
Storage: Store below 30°C. Keep in the original package to protect from moisture.