Leaflet APIXABAN AUROBINDO 5mg film-coated tablets


Indicated for: prevention and treatment of thromboembolism

Route of administration: oral

Substance: apixaban (anticoagulant)

ATC: B01AF02 (Blood and blood forming organs | Antithrombotic agents | Direct factor xa inhibitors)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Bleeding risk
Bleeding risk

This medicine may increase the risk of bleeding.

Apixaban is an oral anticoagulant from the class of direct factor Xa inhibitors, used for the prevention and treatment of thromboembolic disorders. It is indicated for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Apixaban works by inhibiting factor Xa, an essential enzyme in the coagulation process, thereby reducing the formation of blood clots. Unlike traditional anticoagulants such as warfarin, apixaban does not require regular INR (prothrombin time) monitoring and has fewer drug interactions.

Common side effects include minor bleeding, such as nosebleeds (epistaxis) or bruising. In rare cases, severe bleeding, such as gastrointestinal or intracranial hemorrhage, may occur. Patients should inform their doctor about any signs of unusual bleeding.

Apixaban should be used with caution in patients with severe renal impairment, liver disease, or an increased risk of bleeding. It is contraindicated in patients with active bleeding or those undergoing treatments that significantly increase the risk of hemorrhage.

General data about APIXABAN AUROBINDO 5mg

  • Substance: apixaban
  • Date of last drug list: 01-09-2021
  • Commercial code: W67805001
  • Concentration: 5mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 14
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: APL SWIFT SERVICES (MALTA) LTD. - MALTA
  • Holder: AUROBINDO PHARMA ROMANIA S.R.L. - ROMANIA
  • Number: 13800/2021/01
  • Shelf life: 2 years

Pharmaceutical forms available for apixaban

Concentrations available for apixaban

  • 1.25mg/ml
  • 2.5mg
  • 5mg