September 4, 2015
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Bacteriostatic Water

Warnings
Precautions

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 (bacteriostatic water (bacteriostatic water for injection) for injection) for Injection without a solute may result in hemolysis.

PRECAUTIONS

Do not use Bacteriostatic Water (bacteriostatic water (bacteriostatic water for injection) for injection) for Injection, USP for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture.

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.

Inspect 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 (bacteriostatic water for injection) for Injection. It is also not known whether Bacteriostatic Water (bacteriostatic water (bacteriostatic water for injection) for injection) for Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacteriostatic Water (bacteriostatic water (bacteriostatic water for injection) for injection) for Injection, USP containing additives should be given to a pregnant woman only if clearly needed.

Pediatric Use

The safety and effectiveness of Bacteriostatic Water (bacteriostatic water (bacteriostatic water for injection) for injection) 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.

Last reviewed on RxList: 1/26/2009
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions

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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