heparin sodium in 0.9% 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, Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis (5.2)

11/2024

Warnings and Precautions, Heparin Resistance (5.4)

11/2024

Warnings and Precautions, Hypersensitivity Reactions (5.5)

11/2024

Warnings and Precautions, Hyperkalemia (5.7)

7/2024

Warnings and Precautions, Elevations of Serum Aminotransferases (5.8)

11/2024

INDICATIONS AND USAGE

Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency. (1)

DOSAGE AND ADMINISTRATION

Infuse through intravenous catheter at a rate of 6 units per hour. (2.2)

DOSAGE FORMS AND STRENGTHS

•
Injection: 1,000 USP units in Sodium Chloride per 500 mL single-dose infusion bag (2 units per mL) (3)
•
Injection: 2,000 USP units in Sodium Chloride per 1,000 mL single-dose infusion bag (2 units per mL) (3)

CONTRAINDICATIONS

Heparin Sodium in Sodium Chloride Injection is contraindicated in patients with the following conditions: (4)

•
Uncontrollable active bleeding state, except when this is due to disseminated intravascular coagulation (5.1)
•
History of heparin-induced thrombocytopenia (HIT) and heparin‑induced thrombocytopenia with thrombosis (HITT) (5.2)
•
Severe thrombocytopenia (5.2, 5.3)
•
Known hypersensitivity to heparin or pork products (5.5, 6.1)

WARNINGS AND PRECAUTIONS

•
Hemorrhage: Fatal hemorrhages have occurred. Monitor for signs of bleeding and manage promptly. (5.1)
•
HIT and HITT: Monitor for signs and symptoms and discontinue if indicative of HIT or HITT. (5.2)
•
Thrombocytopenia: Monitor platelet count during therapy; discontinue heparin if HIT or HITT is suspected. (5.3)
•
Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients. (5.4)
•
Hypersensitivity Reactions: Use in patients with prior reactions only in life-threatening situations. (5.5)
•
Increased Risk of Bleeding in Older Patients, Especially Women: A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age. (5.6)
•
Hyperkalemia: Measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients. (5.7)
•
Elevations of Serum Aminotransferases: Interpret elevation of these enzymes with caution. (5.8)
•
Laboratory Tests: Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration. (5.9)

ADVERSE REACTIONS

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

USE IN SPECIFIC POPULATIONS

Geriatric Use: A higher incidence of bleeding has been reported in patients over 60 years of age, especially women. (5.6, 8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2024

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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, Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis (5.2)

11/2024

Warnings and Precautions, Heparin Resistance (5.4)

11/2024

Warnings and Precautions, Hypersensitivity Reactions (5.5)

11/2024

Warnings and Precautions, Hyperkalemia (5.7)

7/2024

Warnings and Precautions, Elevations of Serum Aminotransferases (5.8)

11/2024

INDICATIONS AND USAGE

Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency. (1)

DOSAGE AND ADMINISTRATION

Infuse through intravenous catheter at a rate of 6 units per hour. (2.2)

DOSAGE FORMS AND STRENGTHS

•
Injection: 1,000 USP units in Sodium Chloride per 500 mL single-dose infusion bag (2 units per mL) (3)
•
Injection: 2,000 USP units in Sodium Chloride per 1,000 mL single-dose infusion bag (2 units per mL) (3)

CONTRAINDICATIONS

Heparin Sodium in Sodium Chloride Injection is contraindicated in patients with the following conditions: (4)

•
Uncontrollable active bleeding state, except when this is due to disseminated intravascular coagulation (5.1)
•
History of heparin-induced thrombocytopenia (HIT) and heparin‑induced thrombocytopenia with thrombosis (HITT) (5.2)
•
Severe thrombocytopenia (5.2, 5.3)
•
Known hypersensitivity to heparin or pork products (5.5, 6.1)

WARNINGS AND PRECAUTIONS

•
Hemorrhage: Fatal hemorrhages have occurred. Monitor for signs of bleeding and manage promptly. (5.1)
•
HIT and HITT: Monitor for signs and symptoms and discontinue if indicative of HIT or HITT. (5.2)
•
Thrombocytopenia: Monitor platelet count during therapy; discontinue heparin if HIT or HITT is suspected. (5.3)
•
Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients. (5.4)
•
Hypersensitivity Reactions: Use in patients with prior reactions only in life-threatening situations. (5.5)
•
Increased Risk of Bleeding in Older Patients, Especially Women: A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age. (5.6)
•
Hyperkalemia: Measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients. (5.7)
•
Elevations of Serum Aminotransferases: Interpret elevation of these enzymes with caution. (5.8)
•
Laboratory Tests: Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration. (5.9)

ADVERSE REACTIONS

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

USE IN SPECIFIC POPULATIONS

Geriatric Use: A higher incidence of bleeding has been reported in patients over 60 years of age, especially women. (5.6, 8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2024
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