Fonidel Injection 2.5mg/0.5ml

IndicationsFonidel is a Factor Xa inhibitor (anticoagulant) indicated for:

Prophylaxis of deep vein thrombosis (DVT) in patients undergoing-

• hip fracture surgery (including extended prophylaxis)
• hip replacement surgery
• knee replacement surgeryor
• abdominal surgery.
  Treatment of Prophylaxis of deep vein thrombosis (DVT) or acute pulmonary embolism (PE) when administered in conjunction with warfarin.

Pharmacology

The antithrombotic activity of Fondaparinux Sodium is the result of selective inhibition of Factor Xa. By selectively binding to antithrombin III (ATIII), Fondaparinux Sodium potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII.

Interaction

Discontinue agents that may enhance the risk of hemorrhage prior to initiation of therapy with Fonidel unless essential. If co-administration is necessary, monitor patients closely for hemorrhage.

Contraindications

Fondaparinux Sodium is contraindicated in the following conditions:

• Severe renal impairment (creatinine clearance <30 mL/min)
• Active major bleeding
• Bacterial endocarditis
• Thrombocytopenia
• Body weight <50 kg (venous thromboembolism [VTE] prophylaxis only)
• History of serious hypersensitivity reaction to Fondaparinux Sodium

Side Effects

The most common adverse reactions associated with the use of Fonidel are-bleeding complications, mild local irritation (injection site bleeding, rash and pruritus) following subcutaneous injection, anemia, insomnia, hypokalemia, dizziness, hypotension, confusion, bullous eruption, hematoma & post-operative hemorrhage.

Pregnancy & Lactation

Pregnancy Category B. It is not known whether Fondaparinux sodium is excreted in human milk. Caution should be exercised when Fondaparinux Sodium is administered to a nursing woman.

Precautions & Warnings

• Use with caution in patients who have conditions or are taking concomitant medications that increase risk of hemorrhage
• Bleeding risk is increased in renal impairment and in patients with low body weight <50 kg
• Consider the potential risks and benefits before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis
• Thrombocytopenia can occur with administration of Fonidel
• Periodic routine complete blood counts (including platelet counts), serum creatinine level and stool occult blood tests are recommended

Therapeutic Class

Parenteral anti-coagulants

Storage Conditions

Store below 25° C. Do not freeze. Keep the medicine out of reach of children.