HEPARIN SODIUM injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Heparin Sodium (UNII: ZZ45AB24CA) (Heparin - UNII:T2410KM04A)

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

Heparin Sodium

Composition:

Heparin 1000 [USP'U] in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Heparin Sodium Injection is indicated for: - 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 - Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures The use of heparin sodium is contraindicated in patients with the following conditions: - History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see Warnings and Precautions (5.3)] - Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions (6.1)] - In whom su

Product summary:

Heparin Sodium Injection, USP preserved with benzyl alcohol is available as follows: Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
HEPARIN SODIUM INJECTIONHIGHLIGHTS OF PRESCRIBING INFORMATIONTHESE
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 USEINITIAL U.S.
APPROVAL: 1939
INDICATIONS AND USAGE
Heparin Sodium Injection is an anticoagulant indicated for (1) (2) (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: (3) (2)
Therapeutic Anticoagulant Effect with Full-Dose Heparin Sodium
Injection (2.3)
(3) (2)
(3) (2)
Deep Subcutaneous (Intrafat) Injection (3) (2)
Use a different site for each injection (3) (2)
Initial Dose (3) (2)
5,000 units by intravenous injection, followed by 10,000 to 20,000
units of a concentrated solution,
subcutaneously (3) (2)
Every 8 hours (3) (2)
(3) (2)
Or (3) (2)
(3) (2)
Every 12 hours (3) (2)
8,000 to 10,000 units of a concentrated solution (3) (2)
(3) (2)
15,000 to 20,000 units of a concentrated solution (3) (2)
(3) (2)
(3) (2)
Intermittent Intravenous Injection (3) (2)
Initial dose (3) (2)
10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium
Chloride Injection, USP (3) (2)
Every 4 to 6 hours (3) (2)
5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9%
Sodium