sodium acetate

INDICATIONS AND USAGE: Sodium Acetate Injection, USP (4 mEq per 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.

DOSAGE AND ADMINISTRATION: Sodium Acetate Injection, USP (4 mEq per 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, USP (4 mEq per 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 Admixture Service only in a laminar flow hood. It should be inserted into the ring sling (plastic hanging device) provided and suspended as a unit in the laminar flow hood. The container closure should be penetrated only one time utilizing a suitable sterile dispensing set which allows measured distribution of the contents. Swab vial stopper with an antiseptic solution. Insert the dispensing set into the vial using aseptic technique (see graphic illustration below ). Once the sterile dispensing set has been inserted into the container, withdrawal of the contents should be accomplished without delay. However, if this is not possible, a maximum time of 4 hours from the initial entry may be allowed to complete fluid aliquoting/transferring operations. Discard the container no later than 4 hours after initial closure puncture. Do not administer unless solution is clear and seal is intact. Figure

CONTRAINDICATIONS: Sodium Acetate Injection, USP (4 mEq per mL) 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 ). 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.

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 3 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 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.) 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 3 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.

OVERDOSAGE In the event of overdosage, discontinue infusion containing sodium acetate immediately and institute corrective therapy as indicated to reduce elevated serum sodium levels, and restore acid-base balance if necessary. (See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .)

HOW SUPPLIED Sodium Acetate Injection, USP 40 mEq is supplied as follows: Total Amounts NDC No. Fill Volume Na + Acetate Concentration 71357-002-01-Glass Fliptop Vial 71357-002-10-Case Containing 10 Units 20 mL 40 mEq 40 mEq 16.4% 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: Total Amounts NDC No. Fill Volume Na + Acetate Concentration 71357-007-01– Glass Fliptop Vial 71357-007-10 – Case Containing 10 Units 50 mL 100 mEq 100 mEq 16.4% 71357-008-01– Glass Fliptop Vial 71357-008-10 – Case Containing 10 Units 100 mL 200 mEq 200 mEq 16.4% 71357-009-01– Glass Fliptop Vial 71357-009-10 – Case Containing 10 Units 100 mL 400 mEq 400 mEq 32.8% 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 image description