Fragmin (Dalteparin) Drug Information: Overdosage and Contraindications

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May 27, 2012

Fragmin

Deep Vein Thrombosis (DVT) »

Introduction to deep vein thrombosis (DVT)

Arteries have thin muscles within their walls to be able to withstand the pressure of the heart pumping blood to the far reaches of the body. Veins don't have a significant muscle lining, and there is nothing pumping blood back to the heart except physiology. Blood returns to the heart because the body's large muscles squeeze the veins as they contract in their normal activity of moving the body. The normal activities of moving the body returns the blood back to the heart.

There are two types of veins in the leg; superficial veins and deep veins. Superficial veins lie just below the skin and are easily seen on the surface. Deep veins, as their name implies, are located deep within the muscles of the leg. Blood flows from the superficial veins into the deep venous system through small perforator veins. Superficial and perforator veins have one-way valves within them that allow blood to flow only in the direc...

Read the Deep Vein Thrombosis (DVT) article »

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OVERDOSE

An excessive dosage of FRAGMIN (dalteparin) 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 (dalteparin) 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 (dalteparin) 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]
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

Last reviewed on RxList: 12/2/2010
This monograph has been modified to include the generic and brand name in many instances.