(heparin sodium injection CARPUJECT™)

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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

INDICATIONS AND USAGE

Heparin Sodium Injection is an anticoagulant indicated for (1):

•
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
•
Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease
•
Atrial fibrillation with embolization
•
Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)
•
Prevention of clotting in arterial and cardiac surgery
•
Prophylaxis and treatment of peripheral arterial embolism
•
Use as an anticoagulant in blood transfusions, extracorporeal circulation and dialysis procedures

DOSAGE AND ADMINISTRATION

Recommended Adult Dosages:

•
Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3)
* Based on 150 lb (68 kg) patient. Adjust dose based on laboratory monitoring.

Deep, Subcutaneous (Intrafat) Injection

Initial dose

5,000 units by intravenous injection, followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously

Use a different site for each injection.

Every 8 hours
or
Every 12 hours

8,000 to 10,000 units of a concentrated solution

15,000 to 20,000 units of a concentrated solution

Intermittent Intravenous Injection

Initial dose

10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP

Every 4 to 6 hours

5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP

Intravenous Infusion

Initial dose

5,000 units by intravenous injection

Continuous

20,000 to 40,000 units/24 hours in 1,000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion

DOSAGE FORMS AND STRENGTHS

CarpujectTM Single-dose cartridge

•
Heparin Sodium: 5,000 USP units/0.5 mL, Preservative-free (3)
•
Heparin Sodium: 5,000 USP units/1 mL, Preserved with benzyl alcohol (3)

CONTRAINDICATIONS

•
Severe thrombocytopenia (4)
•
Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) (4)
•
When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (4)
•
An uncontrolled 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. Use caution in conditions with increased risk of hemorrhage (5.2)
•
HIT and HITT: Monitor for signs and symptoms and discontinue if indicative of HIT and HITT (5.3)
•
Benzyl Alcohol Toxicity: Do not use benzyl alcohol-preserved drugs in neonates and infants (5.4)
•
Monitoring: Blood coagulation tests guide therapy for full-dose heparin (5.6)
•
Monitor platelet count and hematocrit in all patients receiving heparin (5.5, 5.6)
•
Hyperkalemia: Measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients (5.9)

ADVERSE REACTIONS

Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITT, injection site irritation, general hypersensitivity reactions, and elevations of aminotransferase levels. (6.2)

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: May induce bleeding. (7.2)

USE IN SPECIFIC POPULATIONS

•
Pregnancy: Preservative-free formulation recommended. Limited human data in pregnant women (8.1)
•
Lactation: Advise females not to breastfeed (8.2)
•
Pediatric Use: Use preservative-free formulation in neonates and infants (8.4)
•
Geriatric Use: A higher incidence of bleeding reported in patients, particularly women, over 60 years of age (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2025

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