HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use HEPARIN SODIUM INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM INJECTION.
HEPARIN SODIUM INJECTION, USP for intravenous or subcutaneous use
Initial U.S. Approval: 1939 INDICATIONS AND USAGEHeparin Sodium Injection is an anticoagulant indicated for (1) - •
- Prophylaxis and treatment of venous thrombosis and pulmonary embolism
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- 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
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- Atrial fibrillation with embolization
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- Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)
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- Prevention of clotting in arterial and cardiac surgery
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- Prophylaxis and treatment of peripheral arterial embolism
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- Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures
DOSAGE AND ADMINISTRATIONRecommended Adult Dosages: - •
- Therapeutic Anticoagulant Effect with Full-Dose Heparin† (2.3)
Deep Subcutaneous (Intrafat) Injection
Use a different site for each injection | Initial dose | 5,000 units by intravenous injection, followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously | Every 8 hours or | 8,000 to 10,000 units of a concentrated solution | Every 12 hours | 15,000 to 20,000 units of a concentrated solution | Intermittent Intravenous Injection | Initial dose | 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP | Every 4 to 6 hours | 5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP | Intravenous Infusion | Initial dose | 5,000 units by intravenous injection | Continuous | 20,000 to 40,000 units/24 hours in 1,000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion |
† Based on 150 lb (68 kg) patient. Adjust dose based on laboratory monitoring. DOSAGE FORMS AND STRENGTHS| Injection: Preserved with Benzyl Alcohol, single-dose vials (3) | Injection: Preserved with Benzyl Alcohol, multiple-dose vials (3) |
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1,000 USP units/mL Vial: 1,000 USP units per 1 mL | 1,000 USP units/mL Vial: 10,000 USP units per 10 mL | 5,000 USP units/mL Vial: 5,000 USP units per 1 mL | 1,000 USP units/mL Vial: 30,000 USP units per 30 mL | 10,000 USP units/mL Vial: 10,000 USP units per 1 mL | 5,000 USP units/mL Vial: 50,000 USP units per 10 mL |
CONTRAINDICATIONS- •
- Severe thrombocytopenia (4)
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- Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) (4)
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- When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (4)
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- An uncontrolled active bleeding state, except when this is due to disseminated intravascular coagulation (4)
WARNINGS AND PRECAUTIONS- •
- Fatal Medication Errors: Confirm choice of correct strength prior to administration (5.1)
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- Hemorrhage: Fatal cases have occurred. Use caution in conditions with increased risk of hemorrhage (5.2)
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- HIT and HITT: Monitor for signs and symptoms and discontinue if indicative of HIT and HITT (5.3)
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- Benzyl Alcohol Toxicity: Do not use benzyl alcohol-preserved drugs in neonates and infants (5.4)
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- Monitoring: Blood coagulation tests guide therapy for full-dose heparin (5.6)
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- Monitor platelet count and hematocrit in all patients receiving heparin (5.5, 5.6)
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- Hyperkalemia: Measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients (5.9)
ADVERSE REACTIONSMost common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITT, injection site irritation, general hypersensitivity reactions, and elevations of aminotransferase levels. (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSDrugs that interfere with platelet aggregation: May induce bleeding (7.2) USE IN SPECIFIC POPULATIONS- •
- Pregnancy: Preservative-free formulation recommended. Limited human data in pregnant women. (8.1)
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- Lactation: Advise females not to breastfeed. (8.2)
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- Pediatric Use: Use preservative-free formulation in neonates and infants. (8.4)
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- Geriatric Use: A higher incidence of bleeding reported in patients, particularly women, over 60 years of age. (8.5)
See 17 for PATIENT COUNSELING INFORMATION. Revised: 7/2025 |