STERILE WATER
Clinical safety rating
cautionComprehensive clinical and safety monograph for STERILE WATER (STERILE WATER).
Water serves as a solvent and vehicle for drug administration; it has no intrinsic pharmacological activity.
| Metabolism | Not metabolized; excreted unchanged primarily by the kidneys. |
| Excretion | Renal: >99% as water; fecal: negligible; biliary: negligible |
| Half-life | 1.5–3.5 hours; water turnover depends on physiological state; clinical context: equilibrates rapidly with total body water |
| Protein binding | 0% (water is not protein-bound) |
| Volume of Distribution | 0.6 L/kg (approximates total body water; Vd ~42 L in 70 kg adult) |
| Bioavailability | Intravenous: 100%; Oral: >95% (essentially complete absorption) |
| Onset of Action | Intravenous: immediate (within seconds); Oral: within minutes (absorption via GI tract) |
| Duration of Action | Intravenous: 2–4 hours (until renally excreted); Oral: 1–2 hours (depends on fluid volume administered and renal function) |
| Molecular Weight | 18.015 |
50-100 mL intravenous bolus as a vehicle for drug reconstitution or for hydration; frequency as needed for specific clinical indication.
| Dosage form | LIQUID |
| Renal impairment | No dose adjustment required; however, careful monitoring of fluid balance in patients with renal impairment to avoid fluid overload. |
| Liver impairment | No dose adjustment required; sterile water does not undergo hepatic metabolism. |
| Pediatric use | Dose based on patient weight and clinical need; typical fluid maintenance: 100 mL/kg/day for first 10 kg, plus 50 mL/kg/day for next 10 kg, plus 20 mL/kg/day for weight above 20 kg; administered intravenously. |
| Geriatric use | Use with caution due to potential for fluid overload; adjust volume based on renal function and cardiovascular status; typical starting dose 25-50 mL intravenous bolus. |
| 1st trimester | No known risk; sterile water is considered safe for use in all trimesters as a diluent or for irrigation. |
| 2nd trimester | Safe for use; no teratogenic or adverse effects reported. |
| 3rd trimester | Safe; may be used as a vehicle for medications or for hydration without risk to fetus. |
Clinical note
Comprehensive clinical and safety monograph for STERILE WATER (STERILE WATER).
| Placental transfer | Water freely crosses the placenta; however, sterile water as a substance is physiologic and not associated with adverse effects. |
| Breastfeeding | Sterile water is considered compatible with breastfeeding. No known transfer into breast milk in significant amounts; used as diluent or for hydration without risk to infant. |
| Lactation Rating | Safe |
| Teratogenic Risk | No known teratogenic effects in any trimester; sterile water is not pharmacologically active and does not cross the placenta in quantities that would produce fetal effects. Risk classification: FDA Category A (if considered a drug) or generally recognized as safe. |
| Fetal Monitoring | No specific monitoring required for water administration; however, in intravenous use, monitor for fluid overload (e.g., pulmonary edema, hyponatremia) which could affect both mother and fetus. Assess serum electrolytes if large volumes administered. |
| Fertility Effects | No adverse effects on fertility; sterile water is inert and does not interfere with reproductive function. |
■ FDA Black Box Warning
None.
| Serious Effects |
None known; contraindicated only if hypersensitivity to water (extremely rare) or if specific route (e.g., intravenous) is contraindicated due to patient condition.
| Precautions | Use only sterile water for injection; hypotension and electrolyte disturbances if used in large volumes without electrolytes; hemolysis if administered intravenously without isotonicity. |
| Food/Dietary | No known food interactions. |
| Clinical Pearls | Sterile water is used for dilution or reconstitution of medications before injection. It is not for direct intravenous administration without tonicity adjustment. Use within 2 hours after opening to minimize contamination risk. |
| Patient Advice | This product is not for direct injection; it must be mixed with medication by a healthcare professional. · Do not use if solution is cloudy or contains particulates. · Store at room temperature away from moisture and heat. |
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