Description

 
INDICATIONS AND USAGE 
Heparin Sodium Injection is indicated for: 
Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; 
Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism 
in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of 
developing thromboembolic disease (see DOSAGE AND ADMINISTRATION); 
Prophylaxis and treatment of pulmonary embolism; 
Atrial fibrillation with embolization; 
Diagnosis and treatment of acute and chronic consumptive coagulopathies (disseminated intravascular 
coagulation); 
Prevention of clotting in arterial and cardiac surgery; 
Prophylaxis and treatment of peripheral arterial embolism. 
Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, 
and dialysis procedures and in blood samples for laboratory purposes. 
CONTRAINDICATIONS 
Heparin sodium should NOT be used in patients with the following conditions: 
Severe thrombocytopenia; 
When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, 
etc., cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; 
there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin). 
An uncontrolled active bleeding state (see WARNINGS), except when this is due to disseminated 
intravascular coagulation. 
WARNINGS 
Heparin is not intended for intramuscular use. 
Hypersensitivity 
Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-
threatening situations. (See ADVERSE REACTIONS, Hypersensitivity.) 

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NDA 17-037/S-158 
Page 5 
Hemorrhage 
Hemorrhage can occur at virtually any site in patients receiving heparin. An unexplained fall in 
hematocrit, fall in blood pressure or any other unexplained symptom should lead to serious 
consideration of a hemorrhagic event. 
Heparin sodium should be used with extreme caution in disease states in which there is increased 
danger of hemorrhage. Some of the conditions in which increased danger of hemorrhage exists are: 
Cardiovascular
 
Subacute bacterial endocarditis, severe hypertension. 
Surgical
 
During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially 
involving the brain, spinal cord, or eye. 
Hematologic
 
Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia and 
some vascular purpuras. 
Gastrointestinal
 
Ulcerative lesions and continuous tube drainage of the stomach or small intestine. 
Other
 
Menstruation, liver disease with impaired hemostasis.