Get your patient on Sodium Acetate - Sodium Acetate injection, Solution, Concentrate (Sodium Acetate)

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

Sodium Acetate Injection, USP 40 mEq is administered intravenously only after dilution in a larger volume of fluid . The dose and rate of administration are dependent upon the individual needs of the patient. Serum sodium should be monitored as a guide to dosage. Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of milliequivalents (mEq) of sodium (Na ⁺ ) with an equal number of acetate (CH ₃ COO ^- ).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. See PRECAUTIONS .

CONTRAINDICATIONS

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

ADVERSE REACTIONS

Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions. See WARNINGS and PRECAUTIONS .

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 (CH3COO ^- ). 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 ₃ COONa, a hygroscopic powder very soluble in water.

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 ₃ COO ^- ), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (HCO ₃ ^- ) by metabolic conversion in the liver. This has been shown to proceed readily, even in the presence of severe liver disease.

HOW SUPPLIED

Sodium Acetate Injection, USP 40 mEq is supplied as follows:

Sodium Acetate Injection, USP 40 mEq per 20 mL vials are suppled as 10 vials per carton, with a single package insert.

Each vial is partially filled to provide air space for complete vacuum withdrawal of the contents into the intravenous container.

Store at 20° to 25ºC (68° to 77ºF). [See USP Controlled Room Temperature.]

ALSO AVAILABLE AS

Sodium Acetate Injection, USP is also supplied in Pharmacy Bulk Packages as follows:

Manufactured by:

S.M. Farmaceutici SRL

Tito – 85050, Italy

Distributed by:

Milla Pharmaceuticals Inc., an A.forall Company
White Bear Lake, MN 55110

Revised: June 2024