Drug Facts
Composition & Profile
Identifiers & Packaging
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; PRINCIPAL DISPLAY PANEL Sodium Acetate Injection, USP 40 mEq/20 mL NDC 71357-002-10 Carton Label Sodium Acetate Injection, USP 40 mEq/20 mL NDC 71357-002-01 vial Label image description image description
- 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
- PRINCIPAL DISPLAY PANEL Sodium Acetate Injection, USP 40 mEq/20 mL NDC 71357-002-10 Carton Label Sodium Acetate Injection, USP 40 mEq/20 mL NDC 71357-002-01 vial Label image description image description
Overview
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.
Indications & 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 & 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 .
Warnings & Precautions
WARNINGS Sodium Acetate Injection, USP 40 mEq must be diluted before use. To avoid sodium overload and water retention, infuse sodium-containing solutions slowly. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. Solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Excessive administration of potassium free solutions may result in significant hypokalemia. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
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 .
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