This preparation is designed solely for parenteral use only
after addition of drugs that require dilution or must be dissolved in an aqueous
vehicle prior to injection.
0.9% Sodium Chloride Injection,
USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water
for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat,
antimicrobial agent or added buffer and is supplied only in single-dose containers
to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). The solution
may contain hydrochloric acid and/or sodium hydroxide for pH adjustment.
pH 5.3 (4.5 to 7.0).
Sodium Chloride, USP is chemically
designated NaCl, a white crystalline compound freely soluble in water.
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
Sodium chloride in water dissociates to provide sodium (Na+)
and chloride (Cl⁻) ions. These ions are normal constituents of the
body fluids (principally extracellular) and are essential for maintaining
The distribution and excretion
of sodium (Na+) and chloride (Cl⁻) are largely under the
control of the kidney which maintains a balance between intake and output.
small volume of fluid and amount of sodium chloride provided by 0.9% Sodium
Chloride Injection, USP when used only as an isotonic vehicle for parenteral
injection of drugs, is unlikely to exert a significant effect on fluid and
electrolyte balance except possibly in neonates and very small infants.
is an essential constituent of all body tissues and accounts for approximately
70% of total body weight. Average normal adult daily requirement ranges from
two to three liters (1.0 to 1.5 liters each for insensible water loss
by perspiration and urine production).
is maintained by various regulatory mechanisms. Water distribution depends
primarily on the concentration of electrolytes in the body compartments and
sodium (Na+) plays a major role in maintaining physiologic equilibrium.
INDICATIONS AND USAGE
This parenteral preparation is indicated only for diluting
or dissolving drugs for intravenous, intramuscular or subcutaneous injection,
according to instructions of the manufacturer of the drug to be administered.
Consult the manufacturer’s instructions for choice
of vehicle, appropriate dilution or volume for dissolving the drugs to be
injected, including the route and rate of injection.
Inspectreconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom
from unexpected precipitation or discoloration prior to administration.
Pregnancy Category C.
Animal reproduction studies have not been conducted with
0.9% Sodium Chloride Injection, USP. It is also not known whether sodium chloride
injection containing additives can cause fetal harm when administered to a
pregnant woman or can affect reproduction capacity. Sodium chloride injection
containing additives should be given to a pregnant woman only if clearly needed.
The safety and effectiveness in the pediatric population
are based on the similarity of the clinical conditions of the pediatric and
adult populations. In neonates or very small infants the volume of fluid may
affect fluid and electrolyte balance.
Some drugs for injection may be incompatible in a given vehicle,
or when combined in the same vehicle or in a vehicle containing benzyl alcohol.
Consult with pharmacist, if available.
Use aseptic technique
for single or multiple entry and withdrawal from all containers.
diluting or dissolving drugs, mix thoroughly and use promptly.
not store reconstituted solutions of drugs for injection unless otherwise
directed by the manufacturer of the solute.
Do not use
unless the solution is clear and seal intact. Do not reuse single-dose containers,
discard unused portion.
Reactions which may occur because of this solution, added
drugs or the technique of reconstitution or administration include febrile
response, local tenderness, abscess, tissue necrosis or infection at the site
of injection, venous thrombosis or phlebitis extending from the site of injection
If an adverse reaction does occur,
discontinue the infusion, evaluate the patient, institute appropriate countermeasures,
and if possible, retrieve and save the remainder of the unused vehicle for
Use only as a diluent or solvent. This parenteral preparation
is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload
except possibly in neonates or very small infants. In the event these should
occur, re-evaluate the patient and institute appropriate corrective measures.
See PRECAUTIONS and ADVERSE REACTIONS.
DOSAGE AND ADMINISTRATION
The volume of the preparation to be used for diluting or
dissolving any drug for injection, is dependent on the vehicle concentration,
dose and route of administration as recommended by the manufacturer. This
parenteral should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit.
0.9% Sodium Chloride Injection, USP is supplied in the following:
Fliptop Plastic Vial
Fliptop Plastic Vial
Fliptop Plastic Vial
Intended for use with the LifeShield®
LifeShield® Fliptop Plastic Vial
For use with a luer lock or slip luer
Aluer® Plastic Vial
Aluer Plastic Vial
Store at controlled room temperature 15 to 30°C (59
to 86°F) [See USP.]