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Bacteriostatic Water

Bacteriostatic Water

H2O Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Bacteriostatic Water (bacteriostatic water for injection) is sterile water containing 0.9% benzyl alcohol that is used to dilute or dissolve medications; the container can be reentered multiple times (usually by a sterile needle) and the benzyl alcohol suppresses or stops the growth of most potentially contaminating bacteria. It is available generically and has the same name. The Bacteriostatic Water can be used in diluting drugs that can subsequently be administered by intravenous, intramuscular, or subcutaneous injection. There are few side effects, if any, in adults and if they occur, it they may be related to contamination, particulate matter or the drug that is being dissolved (see below).

Bacteriostatic Water for Injection is supplied in a multiple-dose 30 mL plastic fliptop vial that is plastic and not pressurized. It is not used for neonatal medications because of possible blood pressure changes and toxicity of benzyl alcohol. If Bacteriostatic Water is injected intravenously without any diluted compound, it may cause some red blood cell lysis because it is not isotonic. Some side effects that may occur after drugs are added to Bacteriostatic Water include fever, abscess formation, venous thrombosis or phlebitis, tissue necrosis, and infections.

Our Bacteriostatic Water Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

H2O FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Read the entire FDA prescribing information for H2O (Bacteriostatic Water for Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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