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, for intravenous or subcutaneous use
Initial U.S. Approval: 1939 RECENT MAJOR CHANGES Warnings and Precautions, Unresponsiveness to Heparin with Concomitant Use with Andexanet Alfa (5.5) | 9/2025 |
INDICATIONS AND USAGEHEPARIN SODIUM INJECTION is an anticoagulant indicated for (1): - •
- Prophylaxis and treatment of venous thrombosis and pulmonary embolism
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- Prophylaxis and treatment of the thromboembolic complications associated with atrial fibrillation
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- Treatment of acute and chronic consumption coagulopathies
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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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- Anticoagulant use in transfusion, 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 | 333 units/kg subcutaneously | Every 12 hours | 250 units/kg subcutaneously | Intermittent
Intravenous Injection | Initial Dose | 10,000 units | Every 4 to 6 hours | 5,000 units to 10,000 units | Continuous
Intravenous Infusion | Initial Dose | 5,000 units | Continuous | 20,000 units/24 hours to 40,000 units/24 hours |
* Based on 68 kg patient. Adjust dose based on laboratory monitoring. - •
- Cardiovascular Surgery (2.5)
Intravascular via Total Body Perfusion | Initial Dose | not less than 150 units/kg;
adjust for longer procedures |
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- Low-dose Prophylaxis of Postoperative Thromboembolism (2.6)
Deep Subcutaneous (Intrafat) Injection | Initial Dose | 5,000 units 2 hours before surgery | Every 8 to 12 hours | 5,000 units |
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- Extracorporeal dialysis (2.9)
Intravascular via Extracorporeal Dialysis | 25 units/kg to 30 units/kg followed by infusion rate of 1,500 units/hour to 2,000 units/hour if manufacturers' recommendations are not available |
DOSAGE FORMS AND STRENGTHSPreservative-free, single-dose (3) | Preserved with Benzyl Alcohol, multiple-dose (3) | 1,000 USP units/mL
Vial: 2,000 USP units/2 mL (3) | 1,000 USP units/mL
Vial: 10,000 USP units/10 mL
Vial: 30,000 USP units/30 mL (3) | | 5,000 USP units/mL
Vial: 50,000 USP units/10 mL
Vial: 5,000 USP units/1 mL (3) | | 10,000 USP units/mL
Vial: 10,000 USP units/1 mL (3) |
CONTRAINDICATIONS- •
- History of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITTS) (4)
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- History of thrombocytopenia with pentosan polysulfate (4)
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- Known hypersensitivity to heparin or pork products (4)
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- In whom suitable blood coagulation tests cannot be performed at appropriate intervals (4)
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- An uncontrollable 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: Hemorrhage, including fatal events, has occurred in patients receiving heparin. Use caution in conditions with increased risk of hemorrhage (5.2)
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- HIT and HITTS: Monitor for signs and symptoms and discontinue if indicative of HIT and HITTS (5.3)
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- Benzyl Alcohol Toxicity: Use preservative-free formulation in neonates and infants (5.4)
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- Monitoring: Blood coagulation tests guide therapy for full-dose heparin. Periodically monitor platelet count, hematocrit, and occult blood in stool in all patients receiving heparin (5.6, 5.7)
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- Hyperkalemia: Measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients (5.10)
ADVERSE REACTIONSMost common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITTS, injection site irritation, general hypersensitivity reactions, and elevations of aminotransferase levels. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS- •
- Drugs that interfere with coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding (7.2)
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- Andexanet alfa may reduce the efficacy of heparin when used concomitantly (7.3)
USE IN SPECIFIC POPULATIONS- •
- Pregnancy: Preservative-free formulation recommended (8.1)
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- Lactation: Preservative-free formulation recommended (8.2)
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- Pediatric Use: Use preservative-free formulation in neonates and infants (8.4)
See 17 for PATIENT COUNSELING INFORMATION. Revised: 9/2025 |