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Bacteriostatic Water

Bacteriostatic water for Injection is a sterile diluent that contains
0.9% (9 mg/mL) benzyl alcohol (BnOH) added as a bacteriostatic
preservative, which is used for diluting drugs that are to be injected
intravenously (IV), subcutaneously (SC), or intramuscularly (IM).
Bacteriostatic Water is a preparation designed solely for parenteral use
only after addition of drugs that require dilution or must be dissolved
in an aqueous vehicle prior to injection. Bacteriostatic Water is
supplied in a multiple-dose container from which repeated withdrawals
may be made, over the course of several weeks, without concern for
bacterial growth.

  • Supplied as a sterile, multiple-dose, non-pyrogenic water for injection.
  • Contains 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative.
  • Packaged in a specially fabricated semi-rigid vial formulated of ethylene and propylene.
  • Solutions containing benzyl alcohol should not be used in neonates.

Shelf Life & Expiration Date

Once opened, bacteriostatic water should be used within 4 weeks (28
days) and then discarded after this period of time as per the
manufacturer. The expiration date is 18 months from the date of
manufacture and serves as the date after which Hospira can no longer
guarantee that the water is safe to use.

Safety & Adverse Effects

Bacteriostatic water is safe for IV, IM, and SC injection of diluted
medications and hormones in adults of all ages. 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.

Contraindications

Bacteriostatic water is not safe for use in neonates and should not
be used for epidural or spinal injections in any person. Fluid
replacement with bacteriostatic water is also contraindicated. It should
be used only in small quantities. Not all drugs and injectable
substances are compatible with bacteriostatic water. Users of
bacteriostatic water should pay close attention to warnings and
contraindications on manufacturer packaging. Generally speaking, the
vast majority of products are compatible with benzyl alcohol. Users
should check drug packing for contraindications to specific
bacteriostatic agents (e.g. parabens, sulphites, etc.). Do not use
Bacteriostatic Water for Injection, USP for intravenous injection unless
the osmolar concentration of additives results in an approximate
isotonic admixture.