heparin sodium in 5% dextrose injection 50 units/ml and 100 units/ml Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HEPARIN SODIUM IN 5% DEXTROSE INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM IN 5% DEXTROSE INJECTION.

HEPARIN SODIUM IN 5% DEXTROSE INJECTION, for intravenous use
Initial U.S. Approval: 1939

RECENT MAJOR CHANGES

Contraindications (4)

12/2023

Warnings and Precautions, Hemorrhage (5.2)

12/2023

Warnings and Precautions, Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT) (5.3)

12/2023

Warnings and Precautions, Hypersensitivity Reactions (5.7)

12/2023

Warnings and Precautions, Hyperkalemia (5.8)

12/2023

Warnings and Precautions, Elevations of Serum Aminotransferases (5.9)

12/2023

INDICATIONS AND USAGE

Heparin Sodium in 5% Dextrose 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, either undiluted or in 50 to 100 mL of 5% Dextrose Injection

Subsequent Doses

5,000 to 10,000 Units every 4 to 6 hours, either undiluted or in 50 to 100 mL of 5% Dextrose Injection

Continuous Intravenous Infusion

Initial Dose

5,000 Units by intravenous injection

Continuous

20,000 to 40,000 Units every 24 hours in 1000 mL of 5% Dextrose Injection

*Based on 150 lb. (68 kg) patient.

•
Cardiovascular Surgery (2.5)

Intravascular via Total Body Perfusion

Initial Dose

Greater than or equal to 150 units/kg; adjust for longer procedures

•
Extracorporeal Dialysis (2.8)

Intravascular via Extracorporeal Dialysis

Follow equipment manufacturer's operating directions carefully.

For pediatric dosing see section 2.4 of full prescribing information.

DOSAGE FORMS AND STRENGTHS

•
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection. (3)
•
Heparin Sodium 10,000 USP units per 100 mL (100 USP units per mL) in 5% Dextrose Injection. (3)
•
Heparin Sodium 12,500 USP units per 250 mL (50 USP units per mL) in 5% Dextrose Injection. (3)

CONTRAINDICATIONS

•
History of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITT). (4)
•
Known hypersensitivity to heparin or pork products. (4)
•
In whom suitable blood coagulation tests cannot be performed at appropriate intervals. (4)
•
Uncontrollable 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)
•
Hemorrhage: Fatal cases have occurred. Monitor for signs of bleeding and manage promptly. (5.2)
•
HIT or HITT: Monitor for signs and symptoms and discontinue if indicative of HIT or HITT. (5.3)
•
Thrombocytopenia: Monitor platelet count during therapy; discontinue heparin if HIT or HITT is suspected. (5.4)
•
Monitoring: Blood coagulation tests guide therapy for full-dose heparin. Monitor platelet count and hematocrit in all patients receiving heparin. (5.5)
•
Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients. (5.6)
•
Hypersensitivity Reactions: Use in patients with prior reactions only in life-threatening situations. (5.7)
•
Hyperkalemia: Measure plasma potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients. (5.8)
•
Elevations of Serum Aminotransferases: Interpret elevation of these enzymes with caution. (5.9)

ADVERSE REACTIONS

Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT or HITT, heparin resistance, hypersensitivity reactions, 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 coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HEPARIN SODIUM IN 5% DEXTROSE INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM IN 5% DEXTROSE INJECTION.

HEPARIN SODIUM IN 5% DEXTROSE INJECTION, for intravenous use
Initial U.S. Approval: 1939

RECENT MAJOR CHANGES

Contraindications (4)

12/2023

Warnings and Precautions, Hemorrhage (5.2)

12/2023

Warnings and Precautions, Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT) (5.3)

12/2023

Warnings and Precautions, Hypersensitivity Reactions (5.7)

12/2023

Warnings and Precautions, Hyperkalemia (5.8)

12/2023

Warnings and Precautions, Elevations of Serum Aminotransferases (5.9)

12/2023

INDICATIONS AND USAGE

Heparin Sodium in 5% Dextrose 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, either undiluted or in 50 to 100 mL of 5% Dextrose Injection

Subsequent Doses

5,000 to 10,000 Units every 4 to 6 hours, either undiluted or in 50 to 100 mL of 5% Dextrose Injection

Continuous Intravenous Infusion

Initial Dose

5,000 Units by intravenous injection

Continuous

20,000 to 40,000 Units every 24 hours in 1000 mL of 5% Dextrose Injection

*Based on 150 lb. (68 kg) patient.

•
Cardiovascular Surgery (2.5)

Intravascular via Total Body Perfusion

Initial Dose

Greater than or equal to 150 units/kg; adjust for longer procedures

•
Extracorporeal Dialysis (2.8)

Intravascular via Extracorporeal Dialysis

Follow equipment manufacturer's operating directions carefully.

For pediatric dosing see section 2.4 of full prescribing information.

DOSAGE FORMS AND STRENGTHS

•
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection. (3)
•
Heparin Sodium 10,000 USP units per 100 mL (100 USP units per mL) in 5% Dextrose Injection. (3)
•
Heparin Sodium 12,500 USP units per 250 mL (50 USP units per mL) in 5% Dextrose Injection. (3)

CONTRAINDICATIONS

•
History of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITT). (4)
•
Known hypersensitivity to heparin or pork products. (4)
•
In whom suitable blood coagulation tests cannot be performed at appropriate intervals. (4)
•
Uncontrollable 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)
•
Hemorrhage: Fatal cases have occurred. Monitor for signs of bleeding and manage promptly. (5.2)
•
HIT or HITT: Monitor for signs and symptoms and discontinue if indicative of HIT or HITT. (5.3)
•
Thrombocytopenia: Monitor platelet count during therapy; discontinue heparin if HIT or HITT is suspected. (5.4)
•
Monitoring: Blood coagulation tests guide therapy for full-dose heparin. Monitor platelet count and hematocrit in all patients receiving heparin. (5.5)
•
Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients. (5.6)
•
Hypersensitivity Reactions: Use in patients with prior reactions only in life-threatening situations. (5.7)
•
Hyperkalemia: Measure plasma potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients. (5.8)
•
Elevations of Serum Aminotransferases: Interpret elevation of these enzymes with caution. (5.9)

ADVERSE REACTIONS

Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT or HITT, heparin resistance, hypersensitivity reactions, 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 coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2023
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