Heparin is not intended for intramuscular use.

Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations. (See ADVERSE REACTIONS, Hypersensitivity.)

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:

Subacute bacterial endocarditis, severe hypertension.

During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord or eye.

Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia and some vascular purpuras.

Ulcerative lesions and continuous tube drainage of the stomach or small intestine.

Menstruation, liver disease with impaired hemostasis.

Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of 0 to 30%. Mild thrombocytopenia (count greater than 100,000/mm³) may remain stable or reverse even if heparin is continued. However, thrombocytopenia of any degree should be monitored closely. If the count falls below 100,000/mm³ or if recurrent thrombosis develops (see PRECAUTIONS, GeneralWhite Clot Syndrome), the heparin product should be discontinued. If continued heparin therapy is essential, administration of heparin from a different organ source can be reinstituted with caution.

The 100 unit/mL concentration should not be used in neonates or in infants who weigh less than 10 kg because of the risk of systemic anticoagulation. Caution is necessary when using the 10 unit/mL concentration in premature infants who weigh less than 1 kg who are receiving frequent flushes since a therapeutic heparin dose may be given to the infant in a 24-hour period.

Precautions must be exercised when drugs that are incompatible with heparin are administered through an indwelling intravenous catheter containing Preservative-Free Heparin Lock Flush Solution. (See DOSAGE AND ADMINISTRATION, Maintenance of Patency of Intravenous Devices.) The concentration of phosphorus in the heparin solution is 0.63 mg/mL.

White Clot Syndrome

It has been reported that patients on heparin may develop new thrombus formation in association with thrombocytopenia resulting from irreversible aggregation of platelets induced by heparin, the so-called "white clot syndrome." The process may lead to severe thromboembolic complications like skin necrosis, gangrene of the extremities that may lead to amputation, myocardial infarction, pulmonary embolism, stroke, and possibly death. Therefore, heparin administration should be promptly discontinued if a patient develops new thrombosis in association with thrombocytopenia.

A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age.

Periodic platelet counts, hematocrits and tests for occult blood in stool are recommended during the entire course of heparin use (see DOSAGE AND ADMINISTRATION).

No long-term studies in animals have been performed to evaluate the carcinogenic potential of heparin sodium. Also, no reproduction studies in animals have been performed concerning mutagenesis or impairment of fertility.

Animal reproduction studies have not been conducted with heparin sodium. It is also not known whether heparin sodium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Heparin sodium should be given to a pregnant woman only if clearly needed.

Heparin does not cross the placental barrier.

Heparin is not excreted in human milk.

Safety and effectiveness in pediatric patients have not been established (see WARNINGS, Use in Neonates and Infants).

A higher incidence of bleeding has been reported in patients over 60 years of age, especially women (see CLINICAL PHARMACOLOGY and PRECAUTIONS, General).

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