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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

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

Every 4 to 6 hours

5,000 to 10,000 Units, 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/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

≥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) (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)
•
Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products (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)

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: 3/2022

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