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:

Cardinal Health

INN (International Name):

HEPARIN SODIUM

Composition:

HEPARIN 5000 [USP'U] in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

HEPARIN SODIUM- HEPARIN SODIUM INJECTION
CARDINAL HEALTH
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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):
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DOSAGE AND ADMINISTRATION
Recommended Adult Dosages:
*
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Deep Subcutaneous
(Intrafat) Injection
_Use a different site for each_
_injection_
Initial Dose
333 units/kg subcutaneously
Every 12 hours
250 units/kg subcutaneously
Inte rmitte nt
IV Injection
Initial Dose
10,000 units
Every 4 to 6 hours
5,000 to 10,000 units
Continuous
IV Infusion
Initial Dose
5,000 units
Continuous
20,000 to 40,000 units/24 hours
•
Intravascular via Total
Body Perfusion
Initial Dose
≥150 units/kg;
adjust for longer
proce dure s
•
Deep Subcutaneous
(Intrafat) Injection
Initial Dose
5,000 units 2 hours
before surgery
Every 8 to 12 hours
5,000 units
•
Intravascular via
Extracorporeal Dialysis
25 to 30 units/kg followed by infusion rate of 1,500 to 2,000
units/hour if
manufacturers' recommendations are not available
DOSAGE FORMS AND STRENGTHS
PRE SE RVATIVE -FRE E
PRESERVED WITH BENZYL ALCOHOL
1,000 USP units/mL
1,000 USP units/mL
Prophylaxis and treatment of venous thromboembolism
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
Based on 150 lb. (68 kg) patient. Adjust dose based on laboratory
monitoring.
Therapeutic Anticoagulant Effect with Full-Dose Heparin (2.3)
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Cardiovascular Surgery (2.5)
Low-dose Prophylaxis of Postoperative Thromboembolism (2.6)