Arixtra

Arixtra

fondaparinux sodium

Manufacturer:

Aspen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Fondaparinux Na
Indications/Uses
2.5 mg: Prevention of venous thromboembolic events (VTE) in patients undergoing major orthopaedic lower limbs surgery eg, hip fracture, knee or hip replacement surgery. Prevention of VTE in patients undergoing abdominal surgery at risk of thromboembolic complications & in medical patients at risk of thromboembolic complications due to restricted mobility during acute illness. Unstable angina or non-ST segment elevation MI in patients for whom an urgent (<120 min) invasive management is not indicated; ST segment elevation MI in patients who are managed w/ thrombolytics or who initially are to receive no other form of reperfusion therapy. 7.5 mg: Acute DVT & acute pulmonary embolism (PE).
Dosage/Direction for Use
Adult Prevention of VTE: Orthopaedic & abdominal surgery 2.5 mg SC once daily for 5-9 days, administered 6 hr following surgical closure provided haemostasis has been established. Medical patient at risk of thromboembolic complications 2.5 mg SC once daily for 6-14 days. Unstable angina/non-ST segment elevation MI 2.5 mg SC initiated as soon as possible following diagnosis & continued for up to 8 days or until hospital discharge. ST segment elevation MI 2.5 mg once daily w/ 1st dose administered IV & subsequent doses administered SC. Initiate treatment as soon as possible following diagnosis & continued for up to 8 days or until hospital discharge. DVT & PE >100 kg 10 mg SC once daily, 50-100 kg 7.5 mg SC once daily, <50 kg 5 mg SC once daily. Continue treatment for at least 5 days & until adequate oral anticoagulation is established.
Contraindications
Hypersensitivity. Active clinically significant bleeding, acute bacterial endocarditis. Severe renal impairment in VTE (CrCl <30 mL/min) & in ACS (CrCl <20 mL/min).
Special Precautions
Not to be administered IM. Not recommended as sole anticoagulant during PCI. Increased risk of haemorrhage eg, congenital or acquired bleeding disorders, active ulcerative GI disease, recent intracranial haemorrhage, shortly after brain, spinal or ophth surgery). Spinal/epidural anaesth/spinal puncture; history of heparin-induced thrombocytopenia. Not to be given 24 hr pre-op & 48 hr post-op CABG surgery. May cause allergic reactions due to latex. Not to be administered w/ drugs enhancing risk of haemorrhage eg, GPIIb/IIIa inhibitors or thrombolytics. Severe renal or hepatic impairment. Not to be used during pregnancy. Not recommended during lactation. Patients <17 yr or <50 kg. Elderly ≥75 yr.
Adverse Reactions
Anaemia, bleeding, purpura; oedema.
ATC Classification
B01AX05 - fondaparinux ; Belongs to the class of other antithrombotic agents.
Presentation/Packing
Form
Arixtra inj (pre-filled syringe) 2.5 mg/0.5 mL
Packing/Price
10 × 1's
Form
Arixtra inj (pre-filled syringe) 7.5 mg/0.6 mL
Packing/Price
10 × 1's
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