SODIUM CHLORIDE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)

Available from:

General Injectables and Vaccines, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Chloride Injection, USP, 23.4%, is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirements of the patient with unusual fluid and electrolyte needs. After available clinical and laboratory information is considered and correlated, the appropriate number of milliequivalents of sodium chloride required can be withdrawn from Sodium Chloride Injection, USP, 23.4% and diluted for use. Sodium Chloride Injection is indicated for the treatment of sodium, chloride and water deficiencies that commonly occur in many diseases. Isotonic Sodium Chloride Injection should be limited to cases in which the chloride loss is greater than the sodium loss, as in vomiting from pyloric obstruction, or in which the loss is about equal, as in vomiting from duodenal, jejunal or ileal obstruction and in the replacement of aspirated gastrointestinal fluids. The toxic symptoms that follow various f

Product summary:

Sodium Chloride Injection, USP, 23.4% is supplied as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preservative Free. Discard unused portion. Use only if solution is clear and seal intact. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE
GENERAL INJECTABLES AND VACCINES, INC.
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SODIUM CHLORIDE
Rx only
8008 mOsmol/L (calc.)
(pH 4.5-7.0 when diluted to a concentration of 0.9%)
DESCRIPTION
Sodium Chloride Injection, USP, 23.4%, is a concentrated, nonisotonic,
sterile,
nonpyrogenic solution of sodium chloride 234 mg in Water for
Injection. pH adjusted
with sodium hydroxide or hydrochloric acid if necessary.
Sodium chloride is an electrolyte replenisher. It occurs as colorless
cubic crystals or
white crystalline powder and has a saline taste. Sodium chloride is
freely soluble in water;
it is soluble in glycerin and slightly soluble in alcohol.
The empirical formula for sodium chloride is NaCl and the molecular
weight is 58.44.
CLINICAL PHARMACOLOGY
Sodium chloride comprises over 90% of the inorganic constituents of
the blood serum.
Both its ions are physiologically important. Sodium, more than any
other ion, determines
the osmotic pressure of interstitial fluids and the degree of
hydration of tissues. When
the intake of the chloride ion is less than is excreted, there is a
relative increase in the
blood bicarbonate level, producing the condition known as alkalosis.
Other symptoms of
sodium chloride deficiency are nausea, vomiting and increased
irritability of muscles,
evidenced by cramps and, possibly, convulsions. It is well known that
excessive
sweating will cause ‘‘heatcramps,’’ i.e., muscle cramps in the
abdomen and extremities,
which can be completely relieved only by ingestion of a weak salt
solution.
Approximately 25% of the total body sodium is found in the bone. The
regulation of salt
and water metabolism is governed by different mechanisms; however,
changes in the
intake, distribution and output of salt are, in health, associated
with collateral shifts of
water so that electrolyte concentrations are maintained within a
narrow range. In the
presence of disease affecting the cardiovascular, hepatic or renal
system or in certain
endocrinologic disorders, changes