HEPARIN SODIUM injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A)

Available from:

Pfizer Laboratories Div Pfizer 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; - 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. The use of HEPARIN SODIUM INJECTION is contraindicated in patients: - History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis - History of thrombocytopenia with pentosan polysulfate - Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions (6.1)] - In whom suitable blood coagulation tests (e.g., whole-blood clotting time, partial thromboplastin time) cannot be performed at appropriate inter

Product summary:

HEPARIN SODIUM INJECTION preservative-free is available in the following strengths and package sizes: HEPARIN SODIUM INJECTION preserved with benzyl alcohol is available in the following strengths and package sizes: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Use only if solution is clear and the seal is intact. Do not use if solution is discolored or contains a precipitate.

Authorization status:

New Drug Application

Summary of Product characteristics

HEPARIN SODIUM- HEPARIN SODIUM INJECTION
PFIZER LABORATORIES DIV PFIZER INC
----------
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
RECENT MAJOR CHANGES
Contraindications (4)
9/2019
Warnings and Precautions (5)
9/2019
INDICATIONS AND USAGE
HEPARIN SODIUM INJECTION is an anticoagulant indicated for (1):
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
Prophylaxis and treatment of the thromboembolic complications
associated with atrial fibrillation
Treatment of acute and chronic consumption coagulopathies
Prevention of clotting in arterial and cardiac surgery
Prophylaxis and treatment of peripheral arterial embolism
Anticoagulant use in transfusion, extracorporeal circulation, and
dialysis procedures
DOSAGE AND ADMINISTRATION
Recommended Adult Dosages:
*
Therapeutic Anticoagulant Effect with Full-Dose Heparin (2.3)
Deep Subcutaneous (Intrafat)
Inje ction
_Use a different site for each injection_
Initial Dose
333 units/kg subcutaneously
Every 12 hours
250 units/kg subcutaneously
Inte rmitte nt
Intravenous Injection
Initial Dose
10,000 units
Every 4 to 6 hours 5,000 units to 10,000 units
Continuous
Intravenous Infusion
Initial Dose
5,000 units
Continuous
20,000 units/24 hours to 40,000
units/24 hours
Cardiovascular Surgery (2.5)
Intravascular via Total Body Perfusion Initial Dose
not less than 150 units/kg;
adjust for longer procedures
Low-dose Prophylaxis of Postoperative Thromboembolism (2.6)
Deep Subcutaneous (Intrafat)
Inje ction
Initial Dose
5,000 units 2 hours before surgery
Every 8 to 12
hours
5,000 units
Extracorporeal dialysis (2.9)
Intravascular via Extracorporeal Dialysis
25 units/kg to 30 units/kg followed by infusion
rate of 1,500 units/hour to 2,000 units/hour if
manufacturers' recommendations are not
available
Based on 68 kg