sodium acetate injection, solution, concentrate HOSPIRA, INC.
SODIUM ACETATE Injection, USP
40 mEq (2 mEq/mL)
USE ONLY AFTER
DILUTION IN I.V. FLUIDS.
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.
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.
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/liter. 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
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.
Sodium Acetate Injection, USP 40 mEq is contraindicated
in patients with hypernatremia or fluid retention.
Sodium Acetate Injection, USP 40 mEq must be diluted
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
In patients with diminished
renal function, administration of solutions containing sodium ions
may result in sodium retention.
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.
Do not administer unless solution is clear and seal
is intact. Discard unused portion.
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
Solutions containing acetate
ions should be used with caution as excess administration may result
in metabolic alkalosis.
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.
Safety and effectiveness have been established in
the age groups infant to adolescent.
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.
Sodium overload can occur with intravenous infusion
of excessive amounts of sodium-containing solutions. See WARNINGS
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.
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 (CH3COO−).
Parenteral drug products should be inspected
visually for particulate matter and discoloration prior to administration.
Sodium Acetate Injection, USP 40 mEq (2 mEq/mL) is
supplied in a 20 mL partial-fill single-dose Plastic Vial (List No.
Each vial is partially filled to provide
air space for complete vacuum withdrawal of the contents into the
Store at 20° to 25°C
(68° to 77°F). [See USP Controlled Room Temperature.]