Sterile Water for Injection USP-Bacteriostatic Water for Injection USP

These preparations are designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.

Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers to dilute or dissolve drugs for injection.  For IV injection, add sufficient solute to make an approximately isotonic solution.  pH 5.0 to 7.0.

Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of bacteriostatic water for injection packaged in multiple dose vials.  It contains 0.12% methylparaben, 0.012% propylparaben.  pH 4.5 to 7.0.  (NOT FOR USE IN NEWBORNS).

Water for Injection, USP is chemically designated H₂O.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight.  Average normal adult daily requirement ranges from two to three liters (1 to 1.5 liters each for insensible water loss by perspiration and urine production.)

Water balance is maintained by various regulatory mechanisms.  Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na⁺) plays a major role in maintaining physiologic equilibrium.

The small volume of fluid provided by Sterile Water for Injection, USP or Bacteriostatic Water for Injection, USP when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in newborns or very small infants.

These parenteral preparations are 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.

Sterile Water for Injection, USP and Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use.

Bacteriostatic Water for Injection should not be used in patients with a known sensitivity to the antimicrobial preservative employed.

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

Methylparaben and propylparaben are the preservatives contained in Bacteriostatic Water for Injection.  Data is unavailable on the toxicity of such preservatives in newborns.  Where Water for Injection is required for preparing or diluting medications for use in newborns, only preservative-free Sterile Water for Injection should be used.

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.

Use only as a diluent or solvent.  This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in newborn or very small infants.  In the event these should occur, re-evaluate the patient and institute appropriate corrective measures.  (See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.)

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Use aseptic technique for single or multiple entry and withdrawal from all containers.  When diluting or dissolving drugs, mix thoroughly and use promptly.

Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Sterile Water for Injection, USP

*Indicates vial with tear-off seal.

Preservative Free.  Discard unused portion.

Packaged in trays of twenty-five.

Bacteriostatic Water for Injection, USP contains parabens

(NOT FOR USE IN NEWBORNS):

Packaged in trays of twenty-five.

Use only if solution is clear and seal intact.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

address
45778D
Revised: July 2008

PACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water 5 mL Vial Label
NDC 63323-185-05  
18505

STERILE WATER
FOR INJECTION, USP

FOR DRUG DILUENT USE ONLY
Rx only
5 mL Single Dose Vial 

 water
 

PACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water 100 mL Vial Label

NDC 63323-185-00 

185100

STERILE WATER
FOR INJECTION, USP

FOR DRUG DILUENT USE ONLY

Rx only

100 mL Single Dose Vial 

water 

PACKAGE LABEL - PRINCIPAL DISPLAY - Bacteriostatic Water 30 mL Vial Label

NDC 63323-249-30

24930

BACTERIOSTATIC WATER
FOR INJECTION, USP

NOT FOR USE IN NEWBORNS

For Drug Diluent Use Only

Rx only

30 mL Multiple Dose Vial 
water