HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION.
HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION, for intravenous use
Initial U.S. Approval: 1939 RECENT MAJOR CHANGES Warnings and Precautions, Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis (5.2) | 11/2024 | Warnings and Precautions, Unresponsiveness to Heparin with Concomitant Use with Andexanet Alfa (5.3) | 11/2025 | Warnings and Precautions, Heparin Resistance (5.5) | 11/2024 | Warnings and Precautions, Hypersensitivity Reactions (5.6) | 11/2024 | Warnings and Precautions, Elevations of Serum Aminotransferases (5.9) | 11/2024 |
INDICATIONS AND USAGE
Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency. (1)
DOSAGE AND ADMINISTRATION
Infuse through intravenous catheter at a rate of 6 units per hour. (2.2)
DOSAGE FORMS AND STRENGTHS-
- Heparin Sodium in 0.9% Sodium Chloride Injection is available as: (3)
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- Injection: 1,000 USP Units/500 mL (2 USP Units/mL) clear solution in a single-dose flexible plastic container.
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- Injection: 2,000 USP Units/1,000 mL (2 USP Units/mL) clear solution in a single-dose flexible plastic container.
CONTRAINDICATIONS
Heparin Sodium in Sodium Chloride Injection is contraindicated in patients with the following conditions: (4)
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- Uncontrollable active bleeding state, except when this is due to disseminated intravascular coagulation. (5.1)
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- History of heparin-induced thrombocytopenia (HIT) and heparin‑induced thrombocytopenia with thrombosis (HITT). (5.2)
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- Severe thrombocytopenia. (5.2, 5.4)
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- Known hypersensitivity to heparin or pork products. (5.6, 6.1)
WARNINGS AND PRECAUTIONS- •
- Hemorrhage: Fatal hemorrhages have occurred. Monitor for signs of bleeding and manage promptly. (5.1)
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- HIT and HITT: Monitor for signs and symptoms and discontinue if indicative of HIT or HITT. (5.2)
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- Thrombocytopenia: Monitor platelet count during therapy; discontinue heparin if HIT or HITT is suspected. (5.4)
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- Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients. (5.5)
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- Hypersensitivity Reactions: Use in patients with prior reactions only in life-threatening situations. (5.6)
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- Increased Risk of Bleeding in Older Patients, Especially Women: A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age. (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. (5.8)
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- Elevations of Serum Aminotransferases: Interpret elevation of these enzymes with caution. (5.9)
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- Laboratory Tests: Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration. (5.10)
ADVERSE REACTIONS
Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT and HITT, hypersensitivity reactions, heparin resistance, hyperkalemia, and elevations of aminotransferase levels. (6)
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 INTERACTIONS- •
- Drugs that interfere with platelet aggregation or drugs that counteract coagulation may induce bleeding. (7)
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- Andexanet alfa may reduce the efficacy of heparin when used concomitantly. (7.3)
USE IN SPECIFIC POPULATIONS
Geriatric Use: A higher incidence of bleeding has been reported in patients over 60 years of age, especially women. (5.7, 8.5)
See 17 for PATIENT COUNSELING INFORMATION. Revised: 11/2025 |