pharmacopeia
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/api/v1/drug/sodium-acetate

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity.

Indications

Sourced from openFDA
  • 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.ICD-10: E87.1

Contraindications

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

Dosage & administration

Sourced from openFDA

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

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions. See WARNINGS and PRECAUTIONS .

Overdosage

Sourced from openFDA

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 .

Approval history

Sourced from openFDA
  • Aug 13, 1975NDANDA017586Otsuka Icu Medcl
  • Aug 13, 1975NDANDA017609Otsuka Icu Medcl
  • Feb 2, 1979NDANDA017378Baxter Hlthcare
  • May 4, 1983NDANDA018893Hospira
  • Jun 8, 1984NDANDA019024B Braun
  • Jul 20, 1984NDANDA018895Hospira
  • Sep 29, 1989NDANDA019711B Braun
  • Sep 29, 1989NDANDA019696B Braun

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Sodium Acetate, Injection, 100 mEq/50 mL (2 mEq/mL) (NDC 0409-3299-05)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Acetate, Injection, 100 mEq/50 mL (2 mEq/mL) (NDC 0409-3299-26)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Acetate, Injection, 100 mEq/50mL (2 mEq/mL) (NDC 0641-6262-01)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Demand increase for the drug
    Updated
  • Sodium Acetate, Injection, 100 mEq/50mL (2 mEq/mL) (NDC 71357-007-10)Active
    Sponsor: Milla Pharmaceuticals
    Updated
  • Sodium Acetate, Injection, 200 mEq/100 mL (2 mEq/mL) (NDC 0409-3299-06)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Sodium Acetate, Injection, 200 mEq/100 mL (2 mEq/mL) (NDC 0409-3299-25)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Acetate, Injection, 200 mEq/100mL (2 mEq/mL) (NDC 71357-008-10)Active
    Sponsor: Milla Pharmaceuticals
    Updated
  • Sodium Acetate, Injection, 4 meq/100 mL (NDC 63323-032-00)Active
    Sponsor: Fresenius Kabi USA, LLC
    Updated
  • Sodium Acetate, Injection, 40 mEq/20 mL (2 mEq/mL) (NDC 0409-7299-25)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Acetate, Injection, 40 mEq/20 mL (2 mEq/mL) (NDC 0409-7299-73)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Acetate, Injection, 40 mEq/20mL (2 mEq/mL) (NDC 0641-6261-01)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Sodium Acetate, Injection, 40 mEq/20mL (2 mEq/mL) (NDC 71357-002-10)Active
    Sponsor: Milla Pharmaceuticals
    Updated
  • Sodium Acetate, Injection, 400 mEq/100mL (4 mEq/mL) (NDC 71357-009-10)Active
    Sponsor: Milla Pharmaceuticals · Reason: Other
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
529 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use336.2%
  2. 2Nausea295.5%
  3. 3Death285.3%
  4. 4Pyrexia275.1%
  5. 5Dyspnoea254.7%
  6. 6No Adverse Event224.2%
  7. 7Vomiting214.0%
  8. 8Diarrhoea203.8%
  9. 9Pain193.6%
  10. 10Pneumonia193.6%
  11. 11Atrial Fibrillation183.4%
  12. 12Sepsis183.4%
  13. 13Anaemia163.0%
  14. 14Asthenia163.0%
  15. 15Respiratory Failure163.0%

Literature

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Recent PubMed references pinned to Sodium Acetate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 278 ClinicalTrials.gov registrations naming Sodium Acetate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Sodium Acetate work?
Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity.
What is Sodium Acetate used for?
According to FDA labeling, Sodium Acetate carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sodium Acetate?
Sodium Acetate is classified as Electrolyte solutions, Acid-Base Activity, Electrolyte Activity.
What are the brand names for Sodium Acetate?
Sodium Acetate is marketed under brand names including BSS Ophthalmic Solution, Clinimix E 2.75/5, Clinimix E 4.25/10, Clinimix E 4.25/5, Clinimix E 5/15, Clinimix E 5/20, Clinimix E 5/25, Isolyte P.
What are the contraindications for Sodium Acetate?
Sodium Acetate labeling lists contraindications including: Sodium Acetate Injection, USP 40 mEq is contraindicated in patients with hypernatremia or fluid retention.. Always consult the full prescribing information and a clinician.
Note. Data for sodium-acetate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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