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

Sodium acetate injection, 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, 2 mEq/mL 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, transfer the desired amount to other intravenous fluids to provide the appropriate number of milliequivalents (mEq) of sodium acetate.

Sodium acetate injection, 2 mEq/mL in the Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing intravenous nutritional admixtures. Admixtures must be stored under refrigeration and used within 24 hours after compounding.

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

Directions for Dispensing From Pharmacy Bulk Package

The Pharmacy Bulk Package is for use in the Pharmacy Admixtures Service only. For hanger application, Pharmacy Bulk Package has been provided with integrated hanger within the label for your use. Simply pull the tab and hang. The vials should be suspended as a unit in the laminar flow hood.

A single entry through the vial closure should be made with a sterile dispensing set or transfer device. Transfer individual doses to appropriate intravenous infusion solutions. Use of a syringe with needle is not recommended as it may cause leakage and multiple entries will increase the potential of microbial and particulate contamination.

The above process should be carried out under a laminar flow hood using aseptic technique. Discard any unused portion within 4 hours after initial closure entry.

Sodium acetate injection, 2 mEq/mL is contraindicated in patients with hypernatremia or fluid retention.

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

Sodium acetate injection, USP (2 mEq/mL) is a sterile, clear, colorless, 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, USP (anhydrous) which provides 2 mEq each of sodium (Na ⁺ ) and acetate (CH ₃ 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 ₃ COONa, a hygroscopic powder freely 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.

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

Sodium Acetate Injection USP, 100 mEq/50 mL and 200 mEq/100 mL (2 mEq/mL) is sterile, clear, colorless solution filled in 50 mL and 100 mL clear moulded vials with grey rubber stopper and dark red flip top seal and it is supplied in Pharmacy Bulk Packages as follows:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by:

Amneal Pharmaceuticals Pvt. Ltd.

Ahmedabad 382110, INDIA

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 05-2025-00