Sterile Water for Injection

Status

FDA-approved. FDA-approved labeling exists for sterile water for injection as a diluent. Labeling states that it is hypotonic and that intravenous administration without a solute may cause haemolysis, and that the product must be made approximately isotonic before use. Single-dose container, preservative-free.

What it is

Preservative-free water used as a single-use diluent.

What published research measured

Water for injection without preservative, and the compound in this library most frequently misused in a way that causes direct physical harm. It is hypotonic — it contains no solute — so injecting it directly into tissue or the bloodstream without first making the solution approximately isotonic causes red cells to take on water and rupture. Haemolysis from inadvertent administration of plain sterile water is a documented and serious event, and the approved labeling states the restriction explicitly rather than as a caution. Because it holds no preservative it is a single-use product: once entered, the vial provides no defence against microbial growth. It has no pharmacological activity and exists only to reconstitute or dilute.

Source

FDA labeling for sterile water for injection, including the haemolysis warning

Sources

No linked primary source is on file for this entry yet.

Educational use only, never medical advice. No doses.