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Fragmin (Dalteparin Sodium) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Use FRAGMIN with care in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents because of increased risk of bleeding [see Warning and Precautions (5)].

OVERDOSAGE

An excessive dosage of FRAGMIN Injection may lead to hemorrhagic complications. These may generally be stopped by slow intravenous injection of protamine sulfate (1% solution), at a dose of 1 mg protamine for every 100 anti-Xa IU of FRAGMIN given. If the APTT measured 2 to 4 hours after the first infusion remains prolonged, a second infusion of 0.5 mg protamine sulfate per 100 anti-Xa IU of FRAGMIN may be administered. Even with these additional doses of protamine, the APTT may remain more prolonged than would usually be found following administration of unfractionated heparin. In all cases, the anti-Factor Xa activity is never completely neutralized (maximum about 60 to 75%).

Take particular care to avoid overdosage with protamine sulfate. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, give protamine sulfate only when resuscitation techniques and treatment for anaphylactic shock are readily available. For additional information, consult the labeling of Protamine Sulfate Injection, USP, products.

CONTRAINDICATIONS

  • Active major bleeding
  • History of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis.
  • Hypersensitivity to dalteparin sodium (e.g., pruritis, rash, anaphylactic reactions) [see Adverse Reactions (6.2)]
  • In patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN [see Boxed Warning ]; As a treatment for unstable angina and non_q wave MI
  • For prolonged VTE prophylaxis.
  • Hypersensitivity to heparin or pork products
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