Sodium Acetate
FDA Drug Information • Also known as: Sodium Acetate
- Brand Names
- Sodium Acetate
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
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 (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). 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. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.
What Is Sodium Acetate Used For?
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
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 .
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions. See WARNINGS and PRECAUTIONS .
Warnings and 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
CONTRAINDICATIONS Sodium Acetate Injection, USP 40 mEq is contraindicated in patients with hypernatremia or fluid retention.
Overdosage
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
HOW SUPPLIED Sodium Acetate Injection, USP 40 mEq (2 mEq/mL) is supplied as follows: Unit of Sale Concentration Each NDC 0409-7299-25 Tray Containing 25 Units 40 mEq/20 mL (2 mEq/mL) NDC 0409-7299-45 Single-dose Fliptop Vial Each vial is partially filled to provide air space for complete vacuum withdrawal of the contents into the intravenous container. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-1191-3.0 Revised: 11/2020 Logo
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.