Sodium Acetate

APP Pharmaceuticals, LLC

Sodium Acetate Injection, USP

FULL PRESCRIBING INFORMATION: CONTENTS*

• SODIUM ACETATE DESCRIPTION
• CLINICAL PHARMACOLOGY
• SODIUM ACETATE INDICATIONS AND USAGE
• SODIUM ACETATE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Pregnancy
  • Pediatric
• SODIUM ACETATE ADVERSE REACTIONS
• OVERDOSAGE
• SODIUM ACETATE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

FOR ADDITIVE USE ONLY AFTER DILUTION IN IV FLUIDS.

SODIUM ACETATE DESCRIPTION

Sodium Acetate Injection, USP is a sterile, nonpyrogenic, concentrated solution of sodium acetate in Water for Injection.  The solution is administered, after dilution, by the intravenous (IV) route as an electrolyte replenisher.   It must not be administered undiluted.   The solution contains no bacteriostat, antimicrobial agent or added buffer.

Sodium acetate, USP (anhydrous) is chemically designated as CH₃COONa, a hygroscopic powder, very soluble in water. 

The solution is intended as an alternative to sodium chloride to provide sodium ion (Na⁺) for addition to large volume infusion fluids for IV use. 

Each mL contains: 164 mg (2 mEq) or 328 mg (4 mEq) sodium acetate (anhydrous) and Water for Injection q.s.  The pH may have been adjusted with glacial acetic acid (6.0-7.0).  The calculated osmolarity is approximately 4 mOsmol/mL; 4000 mOsmol/L for the 2 mEq product and approximately 8 mOsmol/mL; 8000 mOsmol/L for the 4 mEq product. 

A pharmacy bulk package is a sterile dosage form containing many single doses.  The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion.

CLINICAL PHARMACOLOGY

Sodium (Na⁺) 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 ^– ) by metabolic conversion in the liver.  This has been shown to proceed readily, even in the presence of severe liver disease.

SODIUM ACETATE INDICATIONS AND USAGE

Sodium Acetate Injection, USP is indicated as a source of sodium, for addition to large volume IV fluids to prevent or correct hyponatremia in patients with restricted or no oral intake.  It is also useful as an additive for preparing specific IV fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

SODIUM ACETATE CONTRAINDICATIONS

Sodium acetate is contraindicated in patients with hypernatremia or fluid retention.

WARNINGS

Sodium acetate must be diluted before use.

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.

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 IV 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.

PRECAUTIONS

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.

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 reproduction capacity.  Sodium acetate should be given to a pregnant woman only if clearly needed.

Pediatric

Sodium acetate is not intended for pediatric use.

SODIUM ACETATE ADVERSE REACTIONS

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

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 .

SODIUM ACETATE DOSAGE AND ADMINISTRATION

Sodium acetate 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 IV fluids to provide any desired number of milliequivalents (mEq) of sodium with an equal number of acetate.

Pharmacy bulk packages are for use in a pharmacy admixture service only in a laminar flow hood.  They should be inserted into the ring sling (plastic hanging device) provided and suspended as a unit in the laminar flow hood.  The container closure should be penetrated only one time utilizing a suitable sterile dispensing set which allows measured distribution of the contents.  Swab vial stopper with an antiseptic solution.  Insert the dispensing set into the vial using aseptic technique.  (See graphic illustration below.)

Once the sterile dispensing set has been inserted into the container, withdrawal of the contents should be accomplished without delay.  However, if this is not possible, a maximum time of 4 hours from the initial entry may be allowed to complete fluid aliquoting/transferring operations. Discard the container no later than 4 hours after initial closure puncture.

Do not administer unless solution is clear and seal is intact.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

HOW SUPPLIED

Sodium Acetate Injection, USP, is packaged in a pharmacy bulk package vial, 25 vials per tray and is available as follows:

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

45828E

Revised: March 2008

PACKAGE LABEL - PRINCIPAL DISPLAY - Sodium Acetate Pharmacy Bulk Package Vial Label

NDC 63323-032-61

32B1

Sodium Acetate Injection, USP

Concentrated

Pharmacy Bulk Package — Not for Direct Infusion

4 mEq/mL

For IV Use Only After Dilution

100 mL

Rx only