NDA 17-037/S-158
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Hypersensitivity
Patients with documented hypersensitivity to heparin should be given the drug only in
clearly life-
threatening situations. (See
ADVERSE REACTIONS,
Hypersensitivity.)
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 infants and in patients with 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.
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