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Water for Injection
  • Professionals
  • FDA PI

Water for Injection

Dosage form: injection, solution

Medically reviewed by Drugs.com. Last updated on Jan 24, 2022.

Sterile Water for Injection, USP

FOR DRUG DILUENT USE ONLY

Rx only

DESCRIPTION:

Sterile Water for Injection, USP is a sterile, nonpyrogenic, solute-free preparation of distilled Water for Injection. It is for use only as a sterile solvent or diluent vehicle for drugs or solutions suitable for parenteral administration. The pH is 5.5 (5.0 to 7.0).

Sterile Water for Injection contains no bacteriostat, antimicrobial agent or added

buffer and is intended only for single dose injection after admixture with an appropriate solute or solution. When smaller amounts are required, the unused portion should be discarded.

Sterile Water for Injection is a pharmaceutic aid (vehicle) and parenteral fluid replenisher after addition of an appropriate solute.

Water for Injection, USP is chemically designated H2O.

The flexible container is fabricated from a specially formulated non-plasticized, film

containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

CLINICAL PHARMACOLOGY:

When administered intravenously as a vehicle for drugs, sterile Water for Injection provides a source of water for parenteral fluid replenishment after sufficient solute is introduced to achieve an osmolarity of 112 mOsmol or more per liter.

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 (1.0 to 1...