Sodium Acetate Anhydrous
FDA Drug Information • Also known as: Sodium Acetate Anhydrous
- Brand Names
- Sodium Acetate Anhydrous
- Route
- INTRAVENOUS
- Dosage Form
- SOLUTION, CONCENTRATE
- Product Type
- HUMAN PRESCRIPTION DRUG
⚠ Boxed Warning (Black Box)
Pharmacy Bulk Package. Not for Direct Infusion
Description
DESCRIPTION Sodium acetate injection, USP (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 mL contains 164 mg of sodium acetate (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 glacial 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 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.
What Is Sodium Acetate Anhydrous Used For?
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION 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, peel off the paper liner from both ends of the tape hanger to expose ¾ inch long adhesive portions. Adhere each end to the label on the bottle. 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.
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 (2 mEq/mL) 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 (2 mEq/mL) 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 (2 mEq/mL) is supplied in pharmacy bulk packages as follows: Unit of Sale Concentration Each NDC 70069-047-25 Case Containing 25 Units 100 mEq/50 mL (2 mEq/mL) NDC 70069-047-01 Glass Fliptop Vial NDC 70069-048-20 Case Containing 20 Units 200 mEq/100 mL (2 mEq/mL) NDC 70069-048-01 Glass Fliptop Vial Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
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.