Information about UNIXABAN

Composition: 
Each Film Coated Tablet contains: 2.5 mg or 5 mg of Apixaban.
Indications: 
- Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation:
APIXABAN (apixaban) is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
- Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery:
APIXABAN is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
- Treatment of Deep Vein Thrombosis:
APIXABAN is indicated for the treatment of DVT.
- Treatment of Pulmonary Embolism:
APIXABAN is indicated for the treatment of PE.
- Reduction in the Risk of Recurrence of DVT and PE:
APIXABAN is indicated to reduce the risk of recurrent DVT and PE following initial therapy.
Dosage and Administration:
Recommended Dose:
- Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation:
The recommended dose of APIXABAN for most patients is 5 mg taken orally twice daily.
- Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery:
The recommended dose of APIXABAN is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.
* In patients undergoing hip replacement surgery, the recommended duration of treatment is 35 days.
* In patients undergoing knee replacement surgery, the recommended duration of treatment is 12 days.
- Treatment of DVT and PE:
The recommended dose of APIXABAN is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily.
- Reduction in the Risk of Recurrence of DVT and PE:
The recommended dose of APIXABAN is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE.
Dosage Adjustments:
In patients with nonvalvular atrial fibrillation: The recommended dose of APIXABAN is 2.5 mg twice daily in patients with any 2 of the following characteristics:
- age ≥80 years.
- body weight ≤60 kg.
- serum creatinine ≥1.5 mg/dl.
Co-administration with strong dual CYP3A4 and P-gp inhibitors: For patients receiving APIXABAN doses greater than 2.5 mg twice daily, reduce the dose by 50% when APIXABAN is co-administered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin).
In patients already taking 2.5 mg twice daily, avoid co-administration of APIXABAN with strong dual inhibitors of CYP3A4 and P-gp.
Contraindications:
 APIXABAN is contraindicated in patients with the following conditions:
- Active pathological bleeding.
- Severe hypersensitivity reaction to APIXABAN.
Pregnancy: 
Pregnancy Category B
There are no adequate and well-controlled studies of APIXABAN in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery.
APIXABAN should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.
Lactation:
It is unknown whether apixaban or its metabolites are excreted in human milk.
Women should be instructed either to discontinue breastfeeding or to discontinue
APIXABAN therapy, taking into account the importance of the drug to the mother.
Storage Conditions: 
Don’t store above 30° C . Keep away from light, moisture and high temperature.
Packaging: 
Carton Pack contains 30 F.C. Tablets in blisters .