Drugplain

Sodium Acetate 164 mg/mL

sodium acetate · INJECTION, SOLUTION, CONCENTRATE · Hospira, Inc.

4 Recalls on RecordCurrently in Shortage
Plain English

Sodium Acetate is a injection, solution, concentrate containing sodium acetate at 164 mg/mL, taken intravenous. Manufactured by Hospira, Inc..

Key Facts

Brand Name
Sodium Acetate
Generic Name
sodium acetate
NDC Code (Product)
0409-3299
Manufacturer
Hospira, Inc.
Strength
164 mg/mL
Dosage Form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Marketing Status
Application #
NDA018893
Marketing Start
04/30/2005

Recall History

4 Recalls on Record
Class II04/26/2018

Coast Quality Pharmacy LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II04/18/2016

Baptist Health Medical Towers Pharmacy and Infusion Services

Lack of Sterility Assurance.

TerminatedVoluntary: Firm initiated
Class I03/04/2022

Fresenius Kabi USA, LLC

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

TerminatedVoluntary: Firm initiated
Class II02/26/2013

Hospira Inc.

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use27 reports
nausea18 reports
pyrexia18 reports
diarrhoea17 reports
death15 reports
dyspnoea15 reports
pneumonia15 reports
anaemia13 reports
vomiting13 reports
drug intolerance12 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & 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 .

Warnings

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. Alu

Contraindications

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

Adverse Reactions

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

Frequently Asked Questions

What is Sodium Acetate used for?

Sodium Acetate contains sodium acetate. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.

Is Sodium Acetate a controlled substance?

Sodium Acetate is not classified as a controlled substance by the DEA.

What is the generic name for Sodium Acetate?

The generic name for Sodium Acetate is sodium acetate. There are 5 other brand versions of sodium acetate.

What is the NDC code for Sodium Acetate 164 mg/mL?

The NDC (National Drug Code) for Sodium Acetate 164 mg/mL is 0409-3299, listed by Hospira, Inc..