SODIUM ACETATE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37)

Available from:

Hospira, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Acetate Injection, USP (2 mEq/mL) is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Sodium Acetate Injection, USP (2 mEq/mL) is contraindicated in patients with hypernatremia or fluid retention.

Product summary:

Sodium Acetate Injection, USP (2 mEq/mL) is supplied in Pharmacy Bulk Packages as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0889-3.0 01/2018

Authorization status:

New Drug Application

Summary of Product characteristics

SODIUM ACETATE- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE
HOSPIRA, INC.
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SODIUM ACETATE
INJECTION, USP
2 MEQ/ML
PHARMACY BULK PACKAGE.
NOT FOR DIRECT INFUSION
FOR ADDITIVE USE ONLY AFTER DILUTION
IN INTRAVENOUS FLUIDS.
GLASS FLIPTOP VIAL
Rx only
_DESCRIPTION_
Sodium Acetate Injection, USP (2 mEq/mL) is a sterile, nonpyrogenic,
_concentrated solution_ of sodium
acetate in water for injection. The solution is administered after
dilution by the intravenous route as an
electrolyte replenisher. It must not be administered undiluted. Each
mL contains 164 mg of sodium
acetate (anhydrous) which provides 2 mEq each of sodium (Na ) and
acetate (CH COO ). The solution
contains no bacteriostat, antimicrobial agent or added buffer. May
contain acetic acid for pH adjustment;
the pH is 6.5 (6.0 to 7.0). The osmolar concentration is 4 mOsmol/mL
(calc.); specific gravity 1.081.
The solution is intended as an alternative to sodium chloride to
provide sodium ion (Na ) for addition to
large volume infusion fluids for intravenous use.
Sodium Acetate, USP anhydrous is chemically designated CH COONa, a
hygroscopic powder very
soluble in water.
A Pharmacy Bulk Package is a container of a sterile preparation for
parenteral use that contains many
single doses. The contents are intended for use in a pharmacy
admixture program and are restricted to
the preparation of admixtures for intravenous infusion.
_CLINICAL PHARMACOLOGY_
Sodium is the principal cation of extracellular fluid. It comprises
more than 90% of total cations at its
normal plasma concentration of approximately 140 mEq/liter. The sodium
ion exerts a primary role in
controlling total body water and its distribution.
Acetate (CH COO ) is a hydrogen ion acceptor. It also serves as an
alternate source of bicarbonate
(HCO ) by metabolic conversion in the liver. This conversion has been
shown to proceed readily, even
in the presence of severe liver disease.
_INDICATIONS AND USAGE_
Sodium Acetate Injection, USP (2 mEq/mL) is indicated as a source of
sodium for additio