SODIUM CHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 234 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake.  Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome.  Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes. Sodium chloride injection is contraindicated in patients with hypernatremia or fluid retention.

Product summary:

Sodium Chloride Injection, USP is available in flip-top glass vials.  Product No. NDC No. % NaCI Na + mEq/mL CI – mEq/mL mOsmol/ mL Fill Volume mL 88B1 63323-088-61 23.4 4 4 8 100 88B2 63323-088-63 23.4 4 4 8 200 Packaged in 20 and 10 vials per tray, respectively.  Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Do not permit to freeze.

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SODIUM CHLORIDE INJECITON USP
23.4%
4 mEq/mL
CONCENTRATED
PHARMACY BULK PACKAGE—
NOT FOR DIRECT INFUSION
CONCENTRATED SOLUTIONS FOR USE ONLY AFTER DILUTION WITH COMPATIBLE
IV FLUIDS TO CORRECT SODIUM DEFICIENCY WHEN ORAL REPLACEMENT IS NOT
FEASIBLE.
DESCRIPTION
Sodium Chloride Injection, USP is a sterile, nonpyrogenic,
concentrated solution for intravenous
administration ONLY AFTER DILUTION to replenish electrolytes. The
preparation contains 4
mEq/mL (23.4%) sodium chloride, in Water for Injection. The solution
contains no bacteriostat,
antimicrobial agent or added buffer; pH of the solution ranges from
4.5 to 7.0. Each mL contains:
Sodium chloride 234 mg; Water for Injection q.s. pH may have been
adjusted with hydrochloric acid.
The osmolar concentration of the 4 mEq/mL solution is 8 mOsmol/mL
(calculated). Sodium chloride is
chemically designated NaCI, a white crystalline compound freely
soluble in water.
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 chloride in water dissociates to provide sodium (Na
) and chloride (CI
) ions.
These ions are normal constituents of the body fluids (principally
extracellular) and are essential for
maintaining electrolyte balance.
Sodium is the principal cation of extracellular fluid. It comprises
more than 90% of the total cations at
its normal plasma concentration of approximately 142 mEq/L. While the
sodium ion can diffuse across
cell membranes, intracellular sodium is maintained at a much lower
concentration than extracellular
sodium through the expenditure of energy by the cell (so-called
‘‘sodium cation pu