SODIUM LACTATE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37)

Available from:

Hospira, Inc.

INN (International Name):

SODIUM LACTATE

Composition:

SODIUM LACTATE 5.6 g in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. It 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). NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.

Product summary:

Sodium Lactate Injection, USP 50 mEq (5 mEq/mL) is supplied in 10 mL single-dose plastic vials. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, INC., Lake Forest, IL 60045 USA LAB-1170-1.0 Revised: 11/2017

Authorization status:

New Drug Application

Summary of Product characteristics

SODIUM LACTATE- SODIUM LACTATE INJECTION, SOLUTION, CONCENTRATE
HOSPIRA, INC.
----------
SODIUM LACTATE
Injection, USP
R only
50 MEQ (5 MEQ/ML)
_FOR ADDITIVE USE ONLY AFTER_
_DILUTION IN I.V. FLUIDS TO CORRECT_
_SERUM-BICARBONATE DEFICIT IN ACIDOSIS._
PLASTIC VIAL
DESCRIPTION
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).
Sodium Lactate, USP is chemically designated CH CH(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.
CLINICAL PHARMACOLOGY
Lactate anion [CH CH(OH)COO ] serves the important purpose of
providing "raw material" for
subsequent regeneration of bicarbonate (HCO ) 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 plasma.
Since metabolic convers