SODIUM ACETATE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Acetate Injection, USP 40 mEq 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 40 mEq is contraindicated in patients with hypernatremia or fluid retention.

Product summary:

Sodium Acetate Injection, USP 40 mEq (2 mEq/mL) is supplied as follows: Each vial is partially filled to provide air space for complete vacuum withdrawal of the contents into the intravenous container. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-1191-3.0 Revised: 11/2020

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
SODIUM ACETATE
Injection, USP
40 MEQ/20 ML
(2 MEQ/ML)
_FOR ADDITIVE USE ONLY AFTER_
_DILUTION IN INTRAVENOUS FLUIDS._ RX ONLY
PLASTIC VIAL
DESCRIPTION
Sodium Acetate Injection, USP 40 mEq (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 20 mL contains 3.28 g of
sodium acetate
(anhydrous) which provides 40 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).
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.
The semi-rigid container is fabricated from a specially formulated
polyolefin. It is a
copolymer of ethylene and propylene. The safety of the plastic has
been confirmed by
tests in animals according to USP biological standards for plastic
containers. The
container requires no vapor barrier to maintain the proper drug
concentration.
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 ), a source of hydrogen ion acceptors, is an alternate
source of
bicarbonate (HCO ) by metabolic conversion in the liver. This has been
shown to
proceed readily, even in the presence of severe liver disease.
INDICATIONS AND USAGE
Sodium Acetate Injection, USP 40 mEq is indicated a