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

Find heparin sodium in 5% dextrose injection 50 units/ml and 100 units/ml medical information:

Find heparin sodium in 5% dextrose injection 50 units/ml and 100 units/ml medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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

Prescribing Information
Download Prescribing Information

Health Professional Information

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

Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.