heparin sodium in 0.45% sodium chloride injection Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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, Hyperkalemia (5.8)

7/2024

INDICATIONS AND USAGE

HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION is indicated for: (1)

•
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
•
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation
•
Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation)
•
Prevention of clotting in arterial and cardiac surgery
•
Prophylaxis and treatment of peripheral arterial embolism
•
Anticoagulant use in blood transfusions, extracorporeal circulation and dialysis procedures

DOSAGE AND ADMINISTRATION

Recommended Adult Dosages:

•
Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3)

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 to 40,000 Units/24 hours

*Based on 150 lb (68 kg) patient.

•
Cardiovascular Surgery (2.5)

Intravascular via Total Body Perfusion

Initial Dose

Not less than 150 units/kg; adjust for longer procedures

•
Extracorporeal Dialysis (2.8)
For pediatric dosing see section 2.4 of full prescribing information.

Intravascular via Extracorporeal Dialysis

Follow equipment manufacturer's operating directions carefully.

DOSAGE FORMS AND STRENGTHS

Heparin sodium is available as: (3)

•
Injection: 100 USP Units/mL in Sodium Chloride clear solution (25,000 USP Units/250 mL) in single-dose flexible plastic container
•
Injection: 50 USP Units/mL in Sodium Chloride clear solution (12,500 USP Units/250 mL) in single-dose flexible plastic container
•
Injection: 50 USP Units/mL in Sodium Chloride clear solution (25,000 USP Units/500 mL) in single-dose flexible plastic container

CONTRAINDICATIONS

•
History of Heparin-induced Thrombocytopenia (HIT) (With or Without Thrombosis) (4)
•
Known hypersensitivity to heparin or pork products (4)
•
In whom suitable blood coagulation tests cannot be performed at appropriate intervals (4)
•
With an uncontrollable active bleeding state, except when treating disseminated intravascular coagulation (4)

WARNINGS AND PRECAUTIONS

•
Fatal Medication Errors: Confirm choice of correct strength prior to administration (5.1)
•
Hemorrhage: Fatal cases have occurred. Use caution in conditions with increased risk of hemorrhage (5.2)
•
HIT (With or Without Thrombosis): Monitor for signs and symptoms and discontinue if indicative of HIT (With or Without Thrombosis) (5.3)
•
Monitoring: Blood coagulation tests guide therapy for full-dose heparin.
Monitor platelet count and hematocrit in all patients receiving heparin (5.5)
•
Hyperkalemia: Measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients (5.8)

ADVERSE REACTIONS

Most common adverse reactions are hemorrhage, thrombocytopenia, HIT (With or Without Thrombosis), local irritation, hypersensitivity reactions, and elevations of aminotransferase levels. (6.1)

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 coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2024

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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, Hyperkalemia (5.8)

7/2024

INDICATIONS AND USAGE

HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION is indicated for: (1)

•
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
•
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation
•
Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation)
•
Prevention of clotting in arterial and cardiac surgery
•
Prophylaxis and treatment of peripheral arterial embolism
•
Anticoagulant use in blood transfusions, extracorporeal circulation and dialysis procedures

DOSAGE AND ADMINISTRATION

Recommended Adult Dosages:

•
Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3)

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 to 40,000 Units/24 hours

*Based on 150 lb (68 kg) patient.

•
Cardiovascular Surgery (2.5)

Intravascular via Total Body Perfusion

Initial Dose

Not less than 150 units/kg; adjust for longer procedures

•
Extracorporeal Dialysis (2.8)
For pediatric dosing see section 2.4 of full prescribing information.

Intravascular via Extracorporeal Dialysis

Follow equipment manufacturer's operating directions carefully.

DOSAGE FORMS AND STRENGTHS

Heparin sodium is available as: (3)

•
Injection: 100 USP Units/mL in Sodium Chloride clear solution (25,000 USP Units/250 mL) in single-dose flexible plastic container
•
Injection: 50 USP Units/mL in Sodium Chloride clear solution (12,500 USP Units/250 mL) in single-dose flexible plastic container
•
Injection: 50 USP Units/mL in Sodium Chloride clear solution (25,000 USP Units/500 mL) in single-dose flexible plastic container

CONTRAINDICATIONS

•
History of Heparin-induced Thrombocytopenia (HIT) (With or Without Thrombosis) (4)
•
Known hypersensitivity to heparin or pork products (4)
•
In whom suitable blood coagulation tests cannot be performed at appropriate intervals (4)
•
With an uncontrollable active bleeding state, except when treating disseminated intravascular coagulation (4)

WARNINGS AND PRECAUTIONS

•
Fatal Medication Errors: Confirm choice of correct strength prior to administration (5.1)
•
Hemorrhage: Fatal cases have occurred. Use caution in conditions with increased risk of hemorrhage (5.2)
•
HIT (With or Without Thrombosis): Monitor for signs and symptoms and discontinue if indicative of HIT (With or Without Thrombosis) (5.3)
•
Monitoring: Blood coagulation tests guide therapy for full-dose heparin.
Monitor platelet count and hematocrit in all patients receiving heparin (5.5)
•
Hyperkalemia: Measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients (5.8)

ADVERSE REACTIONS

Most common adverse reactions are hemorrhage, thrombocytopenia, HIT (With or Without Thrombosis), local irritation, hypersensitivity reactions, and elevations of aminotransferase levels. (6.1)

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 coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2024
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