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Fondaparinux Sodium information from DrugsUpdate  

See Available Brands of Fondaparinux Sodium in India

P - Caution when used during pregnancy
L - Caution when used during lactation

Fondaparinux (trade name Arixtra) is an anticoagulant medication chemically related to low molecular weight heparins. Fondaparinux is a synthetic pentasaccharide Factor Xa inhibitor.

Pharmacodynamics

 


Fondaparinux, a synthetic pentasaccharide, acts as a selective inhibitor of activated factor X. It works by binding selectively to ATIII, and potentiates the neutralisation of Factor Xa. This will interrupt the blood coagulation cascade and inhibit both thrombin formation and thrombus development. At the recommended dosage, fondaparinux does not affect fibrinolytic activity or platelet function. It cannot lyse established thrombi and does not affect clotting function tests (e.g. aPPT, INR).


 

Pharmacokinetics

 


Absorption: Rapidly and completely absorbed after SC inj. SC bioavailability: 100%.


Distribution: Protein binding: Extensively bound to antithrombin III.


Excretion: Excreted in the urine as unchanged drug (64 -77% of a dose). Elimination half-life: 17-21 hr; prolonged in renally impaired, elderly and <50 kg.


 

Fondaparinux Sodium Indications / Fondaparinux Sodium Uses

In Prophylaxis of deep vein thrombosis in abdominal and orthopaedic surgery (SC), Deep vein thrombosis (SC),Unstable angina (SC), Acute ST-elevation myocardial infarction (SC).

Fondaparinux Sodium Adverse Reactions / Fondaparinux Sodium Side Effects

 


Bleeding, thrombocytopenia, local irritation (e.g. rash , pruritus, inj site bleeding), increase in LFTs, fever, nausea, vomiting, constipation.


Potentially Fatal: Epidural or spinal haematomas that may result in permanent paralysis; severe haemorrhage.


 

Precautions

Information Not Available

Special Precautions

Increased risk of haemorrhage (e.g. congenital or acquired bleeding disorders), history or active GI ulceration, diabetic retinopathy, uncontrolled hypertension, recent haemorrhagic stroke. Recent brain, spinal or ophthalmic surgery. Elderly, pregnancy, lactation, children ≤17 yr, <50 kg, moderate renal impairment, severe hepatic impairment. Increased risk of spinal or epidural haematomas in patient undergoing spinal/epidural anaesthesia or spinal puncture especially with post-operative use of indwelling epidural catheters and concurrent use of medications affecting haemostasis; epidural catheters to be removed when the anticoagulant effect is minimal and delay fondaparinux prophylaxis for at least 2 hr after spinal-needle removal or removal of any indwelling epidural catheters. In ST segment elevation MI, unstable angina or NSTEMI patients who are to undergo CABG surgery, fondaparinux should not be given during the 24 hr prior to surgery and may be restarted 48 hr post-operatively. Not for IM inj. Alternate inj sites.


Not to be used interchangeably (unit for unit) with heparin, LMWH or heparinoids. Monitor CBC, serum creatinine and stool occult blood regularly. Discontinue if severe renal impairment develops or platelet counts drop to <100,000/mm3.

Other Drug Interactions

Increased risk of bleeding with antiplatelets, NSAIDs, desirudin, fibrinolytic drugs, glycoprotein IIb/IIIa-receptor antagonists, heparin, heparinoids and LMWH.

Dosage

 


Subcutaneous


 Prophylaxis of deep vein thrombosis in abdominal and orthopaedic surgery


Adult: 2.5 mg once daily, starting 6-8 hr after surgery, continue for at least 5-9 days. In high risk patients, 6-14 days or up to 32 days in hip fracture


Subcutaneous


Deep vein thrombosis


Adult: <50 kg: 5 mg once daily, 50-100 kg: 7.5 mg once daily, >100 kg: 10 mg once daily. Treatment duration: 5-9 days, or at least until oral anticoagulation is established.


Subcutaneous


Unstable angina


Adult: For patients in which urgent percutaneous coronary intervention is not planned: 2.5 mg once daily for up to 8 days. For acute ST-elevation MI, 1st dose to be given IV (directly through an existing IV line or as infusion in 25 or 50 ml of 0.9% saline over 1-2 minutes), subsequent doses to be given SC. Initiate treatment as soon as diagnosis is made and continued up to a max of 8 days or until hospital discharge, whichever comes earlier.


Subcutaneous


Acute ST-elevation myocardial infarction


Adult: For patients in which urgent percutaneous coronary intervention is not planned: 2.5 mg once daily for up to 8 days. For acute ST-elevation MI, 1st dose to be given IV (directly through an existing IV line or as infusion in 25 or 50 ml of 0.9% saline over 1-2 minutes), subsequent doses to be given SC. Initiate treatment as soon as diagnosis is made and continued up to a max of 8 days or until hospital discharge, whichever comes earlier


 

Food(before/after)

Information Not Available

List of Contraindications

Fondaparinux Sodium and Pregnancy

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Fondaparinux Sodium and Lactation

Caution when used during Lactation

Fondaparinux Sodium and Children

Information Not Available

Fondaparinux Sodium and Geriatic

Information Not Available

Fondaparinux Sodium and Other Contraindications

Information Not Available

Storage

Subcutaneous: Store between 15-30°C. Do not freeze

Lab interference

Subcutaneous: Store between 15-30°C. Do not freeze

Fondaparinux Sodium brands in India:

Arixtra

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