Bacteriostatic Water
Status
FDA-approved. FDA-approved labeling exists for bacteriostatic water for injection as a diluent for suitable medicinal preparations. Labeling states it is not for use in neonates and restricts it to small-volume parenteral use, and warns that it must be made approximately isotonic before administration.
What it is
Sterile water with benzyl alcohol, used to reconstitute lyophilized vials.
What published research measured
Sterile water containing benzyl alcohol, conventionally 0.9 per cent, as an antimicrobial preservative. The preservative is the entire reason it exists and the entire source of its limitations. It permits repeated entry into the same vial, which plain sterile water does not, and its practical constraints are well established in pharmacy literature: benzyl alcohol is toxic to neonates, where accumulated exposure causes the fatal gasping syndrome, so preserved diluents are contraindicated in newborns; and total benzyl alcohol exposure becomes relevant in large volumes, which is why product labeling limits use to small-volume administration. Benzyl alcohol hypersensitivity is uncommon but documented. It is a diluent and has no pharmacological activity of its own.
Source
FDA labeling for bacteriostatic water for injection, including the neonatal contraindication
Sources
No linked primary source is on file for this entry yet.
Educational use only, never medical advice. No doses.