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:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Heparin Sodium Injection is indicated for: Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; Low-dose regimen for 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 (see DOSAGE AND ADMINISTRATION ); Prophylaxis and treatment of pulmonary embolism; 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. Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures. Heparin sodium should NOT be used in patients with the following conditions: Severe thrombocytopenia; When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thro

Product summary:

Heparin Sodium Injection, USP (porcine) contains parabens and is available as follows: *Packaged in a plastic vial. Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. This container closure is not made from natural rubber latex.

Authorization status:

New Drug Application

Summary of Product characteristics

HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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HEPARIN SODIUM INJECTION, USP
Rx only
DERIVED FROM PORCINE INTESTINAL MUCOSA.
PRESERVED WITH PARABENS.
DESCRIPTION
Heparin is a heterogeneous group of straight-chain anionic
mucopolysaccharides, called
glycosaminoglycans, having anticoagulant properties. Although others
may be present,
the main sugars occurring in heparin are: (1) α-L-iduronic acid
2-sulfate, (2) 2-deoxy-2-
sulfamino-α-D-glucose 6-sulfate, (3) β-D-glucuronic acid, (4)
2-acetamido-2-deoxy-α-D-
glucose and (5) α-L-iduronic acid. These sugars are present in
decreasing amounts,
usually in the order (2)> (1)> (4)> (3)> (5), and are joined by
glycosidic linkages,
forming polymers of varying sizes. Heparin is strongly acidic because
of its content of
covalently linked sulfate and carboxylic acid groups. In heparin
sodium, the acidic
protons of the sulfate units are partially replaced by sodium ions.
Heparin Sodium Injection, USP is a sterile solution of heparin sodium
derived from
porcine intestinal mucosa, standardized for anticoagulant activity, in
water for injection.
It is to be administered by intravenous or deep subcutaneous routes.
The potency is
determined by a biological assay using a USP reference standard based
on units of
heparin activity per milligram.
Structure of Heparin Sodium (representative subunits):
Heparin Sodium Injection, USP (porcine), preserved with parabens, is
available as
follows:
Each mL of the 1,000 units per mL preparation contains: 1,000 USP
Heparin units
(porcine); 9 mg sodium chloride; 1.5 mg methylparaben; 0.15 mg
propylparaben; Water
for Injection q.s. Made isotonic with sodium chloride. Hydrochloric
acid and/or sodium
hydroxide may have been added for pH adjustment (5.0 to 7.5).
Each mL of the 5,000 units per mL preparation contains: 5,000 USP
Heparin units
(porcine); 5 mg sodium chloride; 1.5 mg methylparaben; 0.15 mg
propylparaben; Water
for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have
been added for
pH a