water injection, solution HOSPIRA, INC.
BACTERIOSTATIC WATER for Injection, USP
Multiple-dose Plastic Vial
NOT FOR USE IN NEONATES.
The following 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.
Water for Injection, USP is a sterile, nonpyrogenic preparation of water for
injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic
preservative. It is supplied in a multiple-dose container from which repeated
withdrawals may be made to dilute or dissolve drugs for injection. The pH
is 5.7 (4.5 to 7.0).
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.
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 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
Bacteriostatic 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 very small
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.
Due to the potential toxicity of benzyl alcohol in neonates,
solutions containing benzyl alcohol must not be used in this patient population.
preparations with benzyl alcohol should not be used for fluid replacement.
preparations containing benzyl alcohol should not be used in epidural or spinal
Bacteriostatic Water for Injection,
USP must be made approximately isotonic prior to use.
Benzyl alcohol, a preservative in Bacteriostatic Water for
Injection, USP has been associated with toxicity in neonates. Data are unavailable
on the toxicity of other preservatives in this age group. Where water is required
for preparing or diluting medications for use in neonates, only preservative-free
Sterile Water for Injection should be used.
administration of Bacteriostatic Water for Injection without a solute may
result in hemolysis.
Do not use Bacteriostatic Water for Injection, USP for intravenous
injection unless the osmolar concentration of additives results in an approximate
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.
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
Bacteriostatic Water for Injection. It is also not known whether Bacteriostatic
Water for Injection containing additives can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. Bacteriostatic Water
for Injection, USP containing additives should be given to a pregnant woman
only if clearly needed.
The safety and effectiveness of Bacteriostatic Water for
Injection, USP have not been established in pediatric patients. Due to the
potential for toxicity, solutions containing benzyl alcohol should not be
used in neonates.
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.
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.
use unless the solution is clear and seal intact.
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
Although adverse reactions to intravenous,
intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known
to occur in man, experimental studies of small volume parenteral preparations
containing 0.9% benzyl alcohol in several species of animals have indicated
that an estimated intravenous dose up to 30 mL may be safely given to an adult
without toxic effects. Administration of an estimated 9 mL to a 6 kg infant
or neonate is potentially capable of producing blood pressure changes.
Use only as a diluent or solvent. This parenteral preparation
is unlikely to pose a threat of fluid overload except possibly in very small
infants. In the event these should occur, re-evaluate the patient and institute
appropriate corrective measures. See WARNINGS, 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.
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. See PRECAUTIONS.
Bacteriostatic Water for Injection, USP is supplied in a
multiple-dose 30 mL plastic fliptop vial (List No. 3977).
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]