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Sodium Acetate

Dosage Form: injection, solution, concentrate

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Sodium Acetate INJECTION, USP

2 mEq/mL
4 mOsmol/mL

Rx Only

 100 mL PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

Sodium Acetate Description

Sodium Acetate Injection, USP, 2 mEq/mL, is a sterile, nonpyrogenic solution of Sodium Acetate (C2H3NaO2) in Water for Injection. It must be diluted prior to administration.

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Each mL contains Sodium Acetate (Anhydrous) 164 mg (equivalent to 2 mEq/mL), Water for Injection q.s. pH may be adjusted with Acetic Acid. Contains no bacteriostatic agent or other preservatives.

Sodium Acetate - Clinical Pharmacology

Sodium is the principal cation of extracellular fluid. It comprises more than 90% of total cations at its normal plasma concentration of approximately 140 mEq/L. The sodium ion exerts a primary role in controlling total body water and its distribution.

Acetate (CH3COO¯), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (HCO3¯) formed by metabolic conversion in the liver. This has been shown to proceed readily, even in the presence of severe liver disease.

Indications and Usage for Sodium Acetate

Sodium Acetate Injection, USP, 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.

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.

Contraindications

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

Warnings

Sodium Acetate Injection, USP, 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 overload 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.

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

Sodium replacement therapy should be guided primarily by the serum sodium level. Use with caution in patients with renal 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.

Pregnancy

Teratogenic Effects

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 reproductive capacity. Sodium Acetate should be given to a pregnant woman only if clearly needed.

Adverse Reactions

Sodium overload can occur with intravenous infusion of excessive amounts of sodium containing compounds. (See WARNINGS and PRECAUTIONS.)

Overdosage

In the event of overdosage, discontinue infusion 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).

Sodium Acetate Dosage and Administration

Sodium Acetate Injection, USP (2 mEq/mL), is administered intravenously only after dilution.

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. Withdraw the calculated volume aseptically and transfer to appropriate intravenous fluids to provide the desired number of milliequivalents (mEq) of sodium (Na+) with an equal number of milliequivalents of acetate(CH3COO¯).

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. Discard vial within 4 hours of initial entry.

DIRECTIONS FOR DISPENSING FROM 100 mL PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION

The 100 mL Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only. The 100 mL Pharmacy Bulk Package should be suspended (inverted) by its IV hang label in a laminar flow hood or biological safety cabinet. Prior to entering a Pharmacy Bulk Package remove the flip-off seal and cleanse the rubber closure with a suitable antiseptic agent. Entry into the Pharmacy Bulk Package must be made with a sterile transfer set or other sterile dispensing device and the contents dispensed in aliquots using aseptic technique. Use of a syringe needle is not recommended as it may cause leakage. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS AFTER INITIAL ENTRY. The date and the time initially opened should be recorded in the space provided on the Pharmacy Bulk Package label.

How is Sodium Acetate Supplied

Sodium Acetate Injection, USP 2 mEq/mL

 NDC 0517-2096-25  20 mL Single Dose Vial  Packaged in boxes of 25
 NDC 0517-2500-25  100 mL Pharmacy Bulk Package  Packaged in boxes of 25

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) (See USP Controlled Room Temperature).

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN2096
Rev. 11/05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0517-2096-25

Sodium Acetate
FOR INJECTION, USP
CONCENTRATE
40 mEq/20 mL

(2 mEq/mL)

20 mL SINGLE DOSE VIAL

FOR INTRAVENOUS USE
AFTER DILUTION

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Sodium Acetate 
Sodium Acetate injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-2096
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Acetate ANHYDROUS (SODIUM CATION and ACETATE ION) Sodium Acetate ANHYDROUS 164 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:0517-2096-25 25 VIAL, SINGLE-DOSE (25 VIAL) in 1 TRAY
1 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/30/1990
Labeler - American Regent, Inc. (622781813)
Establishment
Name Address ID/FEI Operations
Luitpold Pharmaceuticals, Inc. 002033710 ANALYSIS(0517-2096), LABEL(0517-2096), MANUFACTURE(0517-2096), PACK(0517-2096), STERILIZE(0517-2096)
Revised: 12/2013
 
American Regent, Inc.
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