BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER (BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER).
Bacteriostatic water for injection is a sterile, nonpyrogenic preparation of water for injection containing 0.9% benzyl alcohol as a bacteriostatic preservative. It does not have intrinsic pharmacological activity; it serves as a diluent or vehicle for reconstitution or dilution of medications. The benzyl alcohol component acts as a bacteriostatic agent by inhibiting bacterial growth, but the primary use is as a solvent.
| Metabolism | Benzyl alcohol is metabolized primarily in the liver via oxidation to benzoic acid, which then conjugates with glycine to form hippuric acid, excreted in urine. |
| Excretion | Renal: 100% as free water. Biliary/fecal: negligible. |
| Half-life | Not applicable; bacteriostatic water is a diluent, not an active drug. It equilibrates with total body water and is excreted renally with a half-life proportional to renal function. In patients with normal renal function, half-life is approximately 1-2 hours, but clinical context is that water distributes freely and is eliminated like ingested water. |
| Protein binding | 0%; water does not bind to proteins. |
| Volume of Distribution | Total body water (approximately 0.6 L/kg). Represents distribution throughout all body compartments. |
| Bioavailability | 100% following intravenous injection. Not applicable for other routes; only used intravenously. |
| Onset of Action | Not applicable; exerts no pharmacological effect. Reconstituted drugs may have immediate onset depending on the active agent, but bacteriostatic water itself has no onset. |
| Duration of Action | Not applicable; bacteriostatic water does not produce a pharmacological action. The duration of any effect from a reconstituted drug is determined by the active pharmaceutical ingredient. |
No standard therapeutic dose; used as a vehicle for reconstitution and dilution of medications. Volume administered depends on the specific drug and indication.
| Dosage form | LIQUID |
| Renal impairment | Not applicable; bacteriostatic water for injection is not a pharmacologically active agent and does not require dose adjustment in renal impairment. However, consider fluid restrictions in patients with renal failure. |
| Liver impairment | Not applicable; no dose adjustment required in hepatic impairment. |
| Pediatric use | Not directly dosed; used as a diluent for pediatric medications. Volume administered is determined by the prescribed drug and patient weight. |
| Geriatric use | No specific dose modification; consider age-related changes in renal function and potential fluid volume sensitivity. Use with caution in elderly patients with comorbidities that may affect fluid balance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER (BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER).
| Breastfeeding | Benzyl alcohol is excreted into breast milk in low amounts. The M/P ratio is not established. Although risk to nursing infant is low with single small-volume doses, repeated or high-volume exposure should be avoided due to potential accumulation and toxicity in neonates. Use with caution and only when clearly indicated. |
| Teratogenic Risk | Bacteriostatic Water for Injection contains benzyl alcohol as a preservative. Benzyl alcohol crosses the placenta and may cause metabolic acidosis, gasping syndrome, and central nervous system depression in neonates, particularly with high or repeated doses. Insufficient data exist for teratogenic risk in first trimester; however, avoid use in pregnant women unless clearly needed. Use in second and third trimesters should be limited to minimal volumes and durations. |
■ FDA Black Box Warning
Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The 'gasping syndrome' (characterized by metabolic acidosis, respiratory distress, renal failure, and CNS depression) can occur in neonates and low-birth-weight infants. This product is contraindicated in neonates and infants less than 28 days old.
| Serious Effects |
Neonates and infants less than 28 days old (due to benzyl alcohol toxicity). Known hypersensitivity to benzyl alcohol or any component of the product. Do not use for intrathecal or epidural administration unless specifically indicated.
| Precautions | Do not use in neonates and infants less than 28 days old due to risk of gasping syndrome. Use caution in patients with hepatic impairment as benzyl alcohol accumulation may occur. Do not use for intravenous injection without proper reconstitution/dilution of medication. Use sterile technique. Do not use if solution is cloudy or contains precipitate. Single-dose container; discard unused portion. Monitor for signs of hypersensitivity. |
| Food/Dietary |
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| Fetal Monitoring | Monitor for signs of benzyl alcohol toxicity in neonate (metabolic acidosis, respiratory distress, neurologic symptoms) if large volumes or repeated doses administered during pregnancy or peripartum. No specific maternal monitoring required beyond standard clinical observation. |
| Fertility Effects | No adverse effects on fertility have been reported with bacteriostatic water. Benzyl alcohol does not have known reproductive toxicity at concentrations present in this product. However, no dedicated fertility studies exist. |
| None known; Bacteriostatic Water for Injection is a sterile, non-pyrogenic preparation of water containing benzyl alcohol as a preservative and does not contain nutrients or electrolytes. Food intake does not affect its use or safety. |
| Clinical Pearls | Bacteriostatic Water for Injection contains 0.9% benzyl alcohol as a preservative and is intended for multiple-dose use. Do not use in neonates (risk of 'gasping syndrome' due to benzyl alcohol toxicity). Not for intravascular injection; use only for reconstitution or dilution of medications for IM or SC administration unless specifically indicated otherwise. Discard any unused portion after 28 days. |
| Patient Advice | This product is only for mixing or diluting medications, not for direct injection unless directed by your healthcare provider. · Do not use if the solution is cloudy, discolored, or contains particles. · Store at room temperature; do not freeze. · Discard any unused portion after 28 days. · Keep out of reach of children; do not use in newborns or infants. |