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.

INN (International Name):

SODIUM ACETATE ANHYDROUS

Composition:

SODIUM ACETATE ANHYDROUS 164 mg in 1 mL

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 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-1192-3.0 Revised: 11/2020

Authorization status:

New Drug Application

Summary of Product characteristics

SODIUM ACETATE- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE
HOSPIRA, INC.
----------
SODIUM ACETATE RX
ONLY
Injection, USP
2 MEQ/ML
PHARMACY BULK PACKAGE.
NOT FOR DIRECT INFUSION
FOR ADDITIVE USE ONLY AFTER DILUTION IN INTRAVENOUS FLUIDS.
Glass Fliptop Vial
_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
addit