Description

Bacteriostatic Water is sterile, non-pyrogenic water that contains 0.9% benzyl alcohol (9mg/mL) added as a bacteriostatic preservative.

This preparation of sterile water and benzyl alcohol (BnOH) allows for repeated withdrawals from a single 30mL plastic vial.

The difference between bacteriostatic water and sterile water is that other sterile waters for injection do not contain a bacteriostatic agent. Therefore, they are single-dose vials and should be discarded after a single use.

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 1.5 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.

INDICATIONS AND USAGE of Bacteriostatic Water

This parenteral preparation is only indicated for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection, according to the instructions provided by the manufacturer of the drug to be administered.

CONTRAINDICATIONS

Due to the potential toxicity of benzyl alcohol in neonates, it is imperative to avoid using solutions containing benzyl alcohol in this patient population.

Do not use parenteral preparations with benzyl alcohol for fluid replacement.

Avoid using parenteral preparations containing benzyl alcohol in epidural or spinal anesthesia procedures.

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

PRECAUTIONS

Do not inject Injection, USP intravenously unless additives result in an approximate isotonic admixture. Moreover,

consult the manufacturer’s instructions for proper drug dissolution, injection route, and rate. In addition,

inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.