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:

McKesson Packaging Services Business Unit of McKesson Corporation

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, USP 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

Product summary:

Heparin Sodium Injection, USP (porcine), preservative free, is available as follows: Sterile, Nonpyrogenic, Preservative Free Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. Discard unused portion. This container closure is not made from natural rubber latex. STORAGE 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
MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION
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HEPARIN SODIUM INJECTION, USP
R ONLY
DERIVED FROM PORCINE INTESTINAL MUCOSA.
Preservative Free
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), preservative free, 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; Water for Injection q.s. Made isotonic with sodium
chloride. Hydrochloric acid
and/or sodium hydroxide may have been added for pH adjustment
(5.0-7.5).
X
CLINICAL PHARMACOLOGY
Heparin inhibits reactions that lead to the clotting of blood and the
formation of fibrin clots both _in vitro_
and _in vivo_. Heparin acts at multiple sites in the normal
coagulation system. Small amounts of heparin in
combination with an