SODIUM ACETATE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM ACETATE (UNII: 4550K0SC9B) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37)

Available from:

Woodward Pharma Services LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Sodium Acetate Injection, USP is supplied in Pharmacy Bulk Packages as follows: 69784-232-10 – Glass Fliptop Vial 69784-232-01 – Case Containing 10 Units Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Manufactured by: S.M. Farmaceutici SRL Tito – 85050, Italy Distributed by: Woodward Pharma Services LLC Wixom, MI 48393 Revised: July 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM ACETATE- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE
WOODWARD PHARMA SERVICES LLC
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SODIUM ACETATE
INJECTION, USP
PHARMACY BULK PACKAGE. NOT FOR DIRECT INFUSION
FOR ADDITIVE USE ONLY AFTER DILUTION
IN IV FLUIDS.
GLASS FLIPTOP VIAL
Rx only
_DESCRIPTION_
Sodium Acetate Injection, USP 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 of 2 mEq/mL product contains 164 mg of sodium acetate
(anhydrous) which
provides 2 mEq each of sodium (Na
) and acetate (CH
COO ). Each mL of 4 mEq/mL
product contains 328 mg of sodium acetate (anhydrous) which provides 4
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.) in
2 mEq/mL product
and 8 mOsmol/mL (calc.) in 4 mEq/mL product; specific gravity 1.081 (2
mEq/mL) and
1.1511 (4 mEq/mL).
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 me