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.

WARNINGS 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.

Intravenous administration of Bacteriostatic Water for Injection without a solute may result in hemolysis.

ADVERSE REACTIONS 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 and extravasation.

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 examination.

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.