Sodium acetate

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Sodium acetate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Sodium acetate is a sodium compound that is FDA approved for the treatment of hyponatremia. Common adverse reactions include sodium overload.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • 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

  • 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 (CH3COO −).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium acetate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium acetate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • 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

  • 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 (CH3COO −).

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium acetate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium acetate in pediatric patients.

Contraindications

  • Sodium Acetate Injection, USP 40 mEq is contraindicated in patients with hypernatremia or fluid retention.

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.

PRECAUTIONS

  • Do not administer unless solution is clear and seal is intact. Discard unused portion.
  • Sodium replacement therapy should be guided primarily by the serum sodium level.
  • Caution should be exercised in administering sodium-containing solutions to patients with severe renal function impairment, cirrhosis, cardiac failure, or other edematous or sodium-retaining states, as well as in patients with oliguria or anuria.
  • Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.
  • Solutions containing acetate ions should be used with caution as excess administration may result in metabolic alkalosis.

Adverse Reactions

Clinical Trials Experience

  • Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Sodium acetate in the drug label.

Drug Interactions

There is limited information regarding Sodium acetate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category C. Animal reproduction studies have not been conducted with sodium acetate. It is also not known whether sodium acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium acetate should be given to a pregnant woman only if clearly needed.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sodium acetate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sodium acetate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sodium acetate with respect to nursing mothers.

Pediatric Use

  • Safety and effectiveness have been established in the age groups infant to adolescent.

Geriatic Use

  • An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
  • Sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Gender

There is no FDA guidance on the use of Sodium acetate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sodium acetate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sodium acetate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sodium acetate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sodium acetate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sodium acetate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Intravenous

Monitoring

There is limited information regarding Monitoring of Sodium acetate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Sodium acetate in the drug label.

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.

Pharmacology

There is limited information regarding Sodium acetate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Sodium acetate Mechanism of Action in the drug label.

Structure

  • 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 CH3COONa, 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.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Sodium acetate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Sodium acetate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Sodium acetate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Sodium acetate in the drug label.

How Supplied

  • Sodium Acetate Injection, USP 40 mEq (2 mEq/mL) is supplied in a 20 mL partial-fill single-dose Plastic Vial (List No. 7299).
  • Each vial is partially filled to provide air space for complete vacuum withdrawal of the contents into the I.V. container.

Storage

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

Images

Drug Images

Package and Label Display Panel

Sodium acetate image.jpg
This image of the FDA label is provided by the National Library of Medicine.
Sodium acetate ingredients and appearance.png
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Sodium acetate in the drug label.

Precautions with Alcohol

  • Alcohol-Sodium acetate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • SODIUM ACETATE

Look-Alike Drug Names

There is limited information regarding Sodium acetate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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