HEPARIN SODIUM- 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:

Sandoz Inc

INN (International Name):

HEPARIN SODIUM

Composition:

HEPARIN 5000 [USP'U] in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Heparin sodium injection is indicated for: The use of heparin sodium injection is contraindicated in patients with the following conditions: Risk Summary There are no available data on Heparin Sodium Injection use in pregnant women to inform a drug- associated risk of major birth defects and miscarriage. In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. No teratogenicity, but early embryo-fetal death was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (MRHD) of 45,000 units/ day (see Data) . Consider the benefits and risks of heparin sodium injection for the mother and possible risks to the fetus when prescribing heparin sodium Injection to a pregnant woman. If available, preservative-free heparin sodium injection is recommended when heparin therapy is needed during pr

Product summary:

Heparin sodium injection, USP (porcine), contains parabens and is available as follows: 1,000 USP Heparin units/mL 0781-3331-96 1 mL fill in a 2 mL vial, Pack of 25 vials 10,000 USP Heparin units/10 mL (1,000 USP Heparin units/mL) 0781-3331-25 10 mL fill in a 10 mL vial, Pack of 25 vials 30,000 USP Heparin units/30 mL (1,000 USP Heparin units/mL) 0781-3331-35 30 mL fill in a 30 mL vial Pack of 25 vials 5,000 USP Heparin units/mL 0781-3327-95 1 mL fill in a 2 mL vial, Pack of 10 vials 0781-3327-96 1 mL fill in a 2 mL vial, Pack of 25 vials 10,000 USP Heparin units/mL 0781-3333-96 1 mL fill in a 2 mL vial, Pack of 25 vials The above products are available in multiple dose, flip-top vials. Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Do not freeze.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HEPARIN SODIUM- HEPARIN SODIUM INJECTION
SANDOZ INC
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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
5,000 units by intravenous injection,
followed by 10,000 units to 20,000 units
of a concentrated solution,
subcutane ously
Every 8 hours
or
Every 12 hours
8,000 units to 10,000 units of a
concentrated solution
15,000 units to 20,000 units of a
conce ntrate d
solution
Intermittent Intravenous Injection
Initial Dose
10,000 units, either undiluted or in 50
mL to 100 mL of 0.9% Sodium Chloride
Injection, USP by intravenous injection
Every 4 to 6 hours
5,000 units to 10,000 units, either
undiluted or in 50 mL to 100 mL of 0.9%
Sodium Chloride Injection, USP
Intravenous Infusion
Initial Dose
5,000 units by intravenous injection
Continuous
20,000 units/24hours to 40,000 units/24
hours in 1,000 mL of 0.9% Sodium
Chloride Injection, USP (or in any
compatible solution) for infusion
DOSAGE FORMS AND STRENGTHS
Heparin sodium is available as: (3)
HEPARIN SODIUM INJECTION (PARABENS):
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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 arteri