Axolta Tablets

Indication

Prevention of venous thromboembolism (VTE) in patients undergoing hip or knee replacement surgery, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

Dosage (summary)

The recommended dose is 10 mg once daily for VTE prophylaxis, 15 mg twice daily for the first 21 days followed by 20 mg once daily for DVT/PE treatment, and 20 mg once daily for stroke prevention in atrial fibrillation.

Onset of Action / Duration

Onset of action is within 2 to 4 hours after oral administration; duration of effect is approximately 24 hours.

Special Populations

• Elderly patients
• Patients with renal impairment
• Patients with hepatic impairment
• Patients with obesity

Pregnancy & Breastfeeding

Rivaroxaban should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not recommended during breastfeeding.

Key Drug Interactions

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase rivaroxaban levels.
• Strong CYP3A4 inducers (e.g., rifampicin, St. John's Wort) may decrease rivaroxaban levels.
• Anticoagulants, antiplatelet agents, and NSAIDs may increase the risk of bleeding.

Contraindications

• Active bleeding
• Severe renal impairment (CrCl < 15 mL/min)
• Hepatic disease associated with coagulopathy
• Hypersensitivity to rivaroxaban or any excipients

Common side effects

• Bleeding complications
• Gastrointestinal disturbances (nausea, diarrhea)
• Elevated liver enzymes
• Anemia

Counselling Points

• Take the medication at the same time each day.
• Do not stop taking rivaroxaban without consulting your healthcare provider.
• Report any signs of bleeding (e.g., unusual bruising, blood in urine or stools) immediately.
• Inform healthcare providers about rivaroxaban use before any surgical or dental procedures.