STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for STERILE WATER FOR INJECTION IN PLASTIC CONTAINER (STERILE WATER FOR INJECTION IN PLASTIC CONTAINER).
Water is a solvent and diluent for parenteral administration; it provides hydration and maintains osmotic balance. It has no pharmacological activity.
| Metabolism | Water is not metabolized; it is distributed throughout body fluids and excreted primarily by the kidneys. |
| Excretion | Renal: >99% as free water; biliary/fecal: negligible |
| Half-life | Approximately 30-45 minutes; rapid redistribution due to constant renal clearance; clinically, water half-life is not typically measured since it is a vehicle |
| Protein binding | 0% (water does not bind to plasma proteins) |
| Volume of Distribution | 0.55-0.7 L/kg (total body water); clinically, water distributes throughout total body water |
| Bioavailability | Intravenous: 100%; subcutaneous: ~100% (complete absorption); intramuscular: ~100% |
| Onset of Action | Intravenous: immediate upon infusion; subcutaneous: within seconds to minutes depending on injection site absorption |
| Duration of Action | Intravenous: effect persists only during infusion and for minutes afterward due to rapid renal excretion; subcutaneous: variable, typically minutes to hours depending on volume and absorption rate (e.g., 15-30 minutes for small volumes) |
Intravenous administration; dose determined by clinical requirements for hydration, drug dilution, or vehicle for parenteral medications. Typical adult maintenance: 30 mL/kg/day, adjusted for electrolyte and fluid status.
| Dosage form | LIQUID |
| Renal impairment | No specific GFR-based dose adjustment; monitor fluid balance and avoid fluid overload in renal impairment. In oliguric or anuric patients (GFR <10 mL/min), reduce volume to match insensible losses plus urine output. |
| Liver impairment | No specific Child-Pugh based modification; use with caution in ascites or edema due to risk of fluid overload. |
| Pediatric use | Weight-based: Neonates and infants: 60-100 mL/kg/day for maintenance; adjust for dehydration or ongoing losses. Administer via intravenous route. |
| Geriatric use | Use lower end of dosing range due to decreased renal function and comorbidities; monitor for fluid overload and electrolyte disturbances. Typical starting dose: 20-30 mL/kg/day intravenously. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for STERILE WATER FOR INJECTION IN PLASTIC CONTAINER (STERILE WATER FOR INJECTION IN PLASTIC CONTAINER).
| Breastfeeding | Compatible with breastfeeding; water distributes into breast milk without known adverse effects. No M/P ratio applicable as it is a non-medicinal vehicle. |
| Teratogenic Risk | Sterile Water for Injection is a parenteral fluid devoid of pharmacologic activity. There is no known teratogenic risk across all trimesters; water is an essential nutrient with no expected fetal harm when administered appropriately. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known hypersensitivity to any component","Use as a large volume intravenous infusion without appropriate additives to achieve isotonicity"]
| Precautions | ["Use only if solution is clear and container is intact","Do not use for intravenous injections that require isotonic solutions unless additives are used to achieve isotonicity","Risk of hemolysis if administered as a large volume hypotonic solution","Monitor for fluid overload in patients with renal impairment or cardiac disease"] |
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| Standard monitoring of maternal vital signs, fluid balance, and injection site assessment. Fetal heart rate monitoring not specifically required unless administered in large volumes for maternal resuscitation. |
| Fertility Effects | No known effects on fertility; water administration does not influence reproductive function. |