sodium lactate injection, solution, concentrate Hospira, Inc.
SODIUM LACTATE Injection, USP
mEq (5 mEq/mL)
ADDITIVE USE ONLY AFTER
IN I.V. FLUIDS TO CORRECT
DEFICIT IN ACIDOSIS.
Sodium Lactate Injection, USP 50 mEq (5 mEq/mL), is a sterile,
nonpyrogenic, concentrated solution of sodium lactate in water for injection.
The solution is administered after dilution by the intravenous route as an
electrolyte replenisher and systemic alkalizer. It
should not be administered undiluted. Each 10 mL vial contains sodium
lactate, anhydrous 5.6 g (50 mEq each of Na+ and lactate anion).
The solution contains no bacteriostat, antimicrobial agent or added buffer.
Contains hydrochloric acid for pH adjustment. The osmolar concentration is
10 mOsmol/mL (calc.). When diluted with water for injection to make a
1/6 molar solution, the pH of sodium lactate injection is 6.5 (6.0 to 7.3).
Lactate, USP is chemically designated CH3CH(OH)COONa, a 60% aqueous
solution miscible in water.
The semi-rigid vial 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.
Lactate anion [CH3CH(OH)COO−]
serves the important purpose of providing “raw material” for
subsequent regeneration of bicarbonate (HCO3−)
and thus acts as a source (alternate) of bicarbonate when normal production
and utilization of lactic acid is not impaired as a result of disordered lactate
metabolism. Lactate anion is usually present in extracellular fluid at a level
of less than 1 mEq/liter, but may attain a level of 10 mEq/liter during exercise.
It is seldom measured as such and thus is one of the “unmeasured anions”
(“anion gap”) in determinations of the ionic composition of
Since metabolic conversion of lactate to bicarbonate
is dependent on the integrity of cellular oxidative processes, lactate may
be inadequate or ineffective as a source of bicarbonate in patients suffering
from acidosis associated with shock or other disorders involving reduced perfusion
of body tissues. When oxidative activity is intact, one to two hours time
is required for conversion of lactate to bicarbonate.
lactate anion is in equilibrium with pyruvate and has an alkalizing effect
resulting from simultaneous removal by the liver of lactate and hydrogen ions.
In the liver, lactate is metabolized to glycogen which is ultimately converted
to carbon dioxide and water by oxidative metabolism.
sodium (Na+) ion combines with bicarbonate ion produced from carbon
dioxide of the body and thus retains bicarbonate to combat metabolic acidosis
(bicarbonate deficiency). The normal plasma level of lactate ranges from 0.9
to 1.9 mEq/liter.
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.
INDICATIONS AND USAGE
Sodium Lactate Injection, USP 50 mEq (5 mEq/mL), is primarily
indicated, after dilution, as a source
of bicarbonate for prevention or control of mild to moderate metabolic acidosis
in patients with restricted oral intake whose oxidative processes are not
seriously impaired. It is not intended nor effective for correcting severe
acidotic states which require immediate restoration of plasma bicarbonate
levels. Sodium lactate has no advantage over sodium bicarbonate and may be
detrimental in the management of lactic acidosis.
Sodium Lactate Injection, USP 50 mEq is contraindicated in
patients suffering from hypernatremia or fluid retention.
should not be used in conditions in which lactate levels are increased (e.g.,
shock, congestive heart failure, respiratory alkalosis) or in which utilization
of lactate is diminished (e.g., anoxia, beriberi).
FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.
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.
patients with diminished renal function, administration of solutions containing
sodium ions may result in sodium retention.
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.
administration of potassium-free solutions may result in significant hypokalemia.
Sodium Lactate Injection, USP 50 mEq must be suitably diluted
before infusion to avoid a sudden increase in the level of sodium or lactate.
Too rapid administration and overdosage should be avoided.
potentially large loads of sodium given with lactate require that caution
be exercised in patients with congestive heart failure or other edematous
or sodium-retaining states, as well as in patients with oliguria or anuria.
must be exercised in the administration of parenteral fluids, especially those
containing sodium ions, to patients receiving corticosteroids or corticotropin.
containing lactate ions should be used with caution as excess administration
may result in metabolic alkalosis.
Do not administer
unless solution is clear and seal is intact. Discard unused portion.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with Sodium Lactate Injection have not been performed
to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when Sodium Lactate Injection is administered to a nursing mother.
Pregnancy Category C.
Animal reproduction studies have not been conducted with
sodium lactate. It is also not known whether sodium lactate can cause fetal
harm when administered to a pregnant woman or can affect reproduction capacity.
Sodium lactate should be given to a pregnant woman only if clearly needed.
The safety and effectiveness of sodium lactate have not been
established in pediatric patients. Its limited use has been inadequate to
fully define proper dosage and limitations for use.
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
to this drug 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.
Adverse effects of sodium lactate are essentially limited
to overdosage of either sodium or lactate ions. See WARNINGS and PRECAUTIONS.
In the event of overdosage, discontinue infusion containing
sodium lactate immediately and institute corrective therapy as indicated to
reduce elevated serum sodium levels and restore acid-base balance if necessary.
See WARNINGS and PRECAUTIONS.
DOSAGE AND ADMINISTRATION
Sodium Lactate Injection, USP 50 mEq (5 mEq/mL) is administered
intravenously only after addition to a larger volume of fluid. The amount
of sodium ion and lactate ion to be added to larger volume intravenous fluids
should be determined in accordance with the electrolyte requirements of each
All or part of the content(s) of
one (50 mEq in 10 mL) or more vial containers may be added to other intravenous
solutions to provide any desired number of milliequivalents of lactate anion
(with the same number of milliequivalents of Na+). The contents
of one container (50 mEq in 10 mL) added to 290 mL of a nonelectrolyte solution
or of sterile water for injection will provide 300 mL of an approximately
isotonic (1/6 molar) concentration of sodium lactate (1.9%), containing 167
mEq/liter each of Na+ and lactate anion.
drug products should be inspected visually for particulate matter and discoloration
prior to administration. See CONTRAINDICATIONS.
Sodium Lactate Injection, USP 50 mEq (5 mEq/mL) is supplied
in 10 mL single-dose plastic vials (List No. 6664).
at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]