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.
Sterile Water for Injection,
USP is a sterile, nonpyrogenic preparation of water for injection which contains
no bacteriostat, antimicrobial agent or added buffer and is supplied only
single-dose containers to dilute or dissolve drugs
for injection. For I.V. injection, add sufficient solute to make an approximately
Water for Injection, USP is chemically
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 labeled volume.
plastic syringe is molded from a specially formulated polypropylene. Solutions
in contact with the plastic container may leach out certain chemical components
from the plastic in very small amounts; however, biological testing was supportive
of the safety of the syringe material.
Water 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).
balance is maintained by various regulatory mechanisms. Water for distribution
depends primarily on the concentration of electrolytes in the body compartments
and sodium (Na+) plays a major role in maintaining physiologic
The small volume of fluid provided by Sterile
Water for Injection, USP when used only as a pharmaceutic aid for diluting
or dissolving drugs for parenteral injection, is unlikely to exert a significant
effect on fluid balance except possibly in neonates or very small infants.
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.
Sterile Water for Injection, USP must be made approximately
isotonic prior to use.
Intravenous administration of Sterile Water for Injection
without a solute may result in hemolysis.
Do not use for intravenous injection unless the osmolar concentration
of additives results in an approximate isotonic admixture.
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.
Inspect reconstituted (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
Sterile Water for Injection. It is also not known whether sterile water containing
additives can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. Sterile Water for Injection with additives should
be given to a pregnant woman only if clearly needed.
Safety and effectiveness have been established in pediatric
patients. However, 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 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 WARNINGS, PRECAUTIONS and
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.
parenteral should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit.
Sterile Water for Injection, USP is supplied in the following:
Plastic Fliptop Vial
Plastic Fliptop Vial
Plastic Fliptop Vial
For use with the LifeShield® Blunt
LifeShield Plastic Fliptop Vial
Store at 20 to 25°C (68 to 77°F). [See USP Controlled