STERILE WATER FOR INJECTION
Clinical safety rating
cautionComprehensive clinical and safety monograph for STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION).
Water serves as a vehicle for dissolving or diluting drugs for parenteral administration; it has no intrinsic pharmacologic activity. It maintains body fluid balance and is essential for cellular homeostasis.
| Metabolism | Water is not metabolized; it is distributed in the body and excreted primarily by the kidneys via urine, with minor losses through skin, lungs, and feces. |
| Excretion | Renal excretion of free water following equilibration with total body water; no active elimination. >99% eliminated via kidneys as urine, with minor losses via insensible routes (skin, lungs) and feces (<1% combined). |
| Half-life | The elimination half-life of water is approximately 7-14 days in healthy adults, reflecting the turnover rate of total body water (TBW). In clinical use, administered water equilibrates rapidly with TBW (half-life <1 hour) and is then subject to normal renal excretion, with a terminal half-life of 7-14 days as part of body water turnover. Clinically, water is not considered to have a meaningful elimination half-life due to rapid equilibration and homeostatic regulation. |
| Protein binding | 0%. Water does not bind to plasma proteins. It is freely diffusible across capillary and cell membranes. |
| Volume of Distribution | Approximately 0.55-0.60 L/kg in adults (total body water: ~42 L in 70 kg). This represents the volume of fluid into which water distributes, essentially the total body water compartment. In clinical pharmacokinetics, Vd is not applicable for water as it is the solvent of the body. |
| Bioavailability | Intravenous: 100%. Subcutaneous: ~100% (water is absorbed completely due to small molecular size and passive diffusion). Oral: ~100% (water is absorbed from gastrointestinal tract via osmosis and aquaporins, with negligible first-pass metabolism). |
| Onset of Action | Intravenous: Immediate (seconds to minutes) for correction of hypovolemia or hypertonicity, as water rapidly distributes within the extracellular and intracellular spaces. Subcutaneous: Onset within 30-60 minutes for rehydration, depending on local perfusion and volume. Oral: Onset of absorption within 5-10 minutes; systemic effect on hydration within 30-60 minutes. |
| Duration of Action | Duration depends on renal function and hydration status. In euvolemic patients, a single intravenous dose (e.g., 250-500 mL) has a transient effect (<30 minutes) on plasma volume expansion, with water redistributing to interstitium and cells. For rehydration, effects persist for hours until renal excretion occurs. No therapeutic duration; water is a vehicle or diluent, not an active drug. |
| Molecular Weight | 18.015 |
Sterile water for injection is not administered directly; it is used as a diluent or solvent for medications. There is no standard therapeutic dose. Administration is via intravenous, intramuscular, or subcutaneous route as required for reconstitution.
| Dosage form | LIQUID |
| Renal impairment | No dose adjustment is needed for renal impairment as sterile water for injection is not systemically active and is used solely as a vehicle. |
| Liver impairment | No dose adjustment is needed for hepatic impairment as sterile water for injection is not systemically active and is used solely as a vehicle. |
| Pediatric use | Weight-based dosing is not applicable; used as a diluent per medication-specific instructions. Volume of sterile water for injection should be adjusted based on the required dose of the reconstituted drug and the patient's weight and clinical condition. |
| Geriatric use | No specific dose adjustment needed for elderly patients; use the minimal volume necessary to achieve desired drug concentration, considering potential fluid and electrolyte imbalances and reduced renal function. |
| 1st trimester | No known teratogenic effects. Used as a diluent; systemic absorption negligible. |
| 2nd trimester | Safe when used as a diluent. No known fetal harm. |
| 3rd trimester | Safe when used as a diluent. No known adverse effects on fetus or neonate. |
Clinical note
Comprehensive clinical and safety monograph for STERILE WATER FOR INJECTION (STERILE WATER FOR INJECTION).
| Placental transfer | Negligible placental transfer due to rapid metabolism and distribution; water equilibrates across placenta with no known active transport. |
| Breastfeeding | Excreted in breast milk in negligible amounts. Considered compatible with breastfeeding. |
| Lactation Rating | L1 |
| Teratogenic Risk | No fetal risk identified; sterile water for injection is isotonic and lacks pharmacological activity. No known teratogenic effects in any trimester. |
| Fetal Monitoring | No specific monitoring required beyond routine clinical observation for injection site reactions. |
| Fertility Effects | No known effects on fertility. |
■ FDA Black Box Warning
For sterile water for injection: Do not use for intravenous injection without first adjusting isotonicity, as administration of free water into the bloodstream can cause severe hemolysis and potentially fatal complications.
| Common Effects | Staining of teeth Stinging sensation Taste change |
| Serious Effects |
Hypersensitivity to any componentAdministration of hypotonic solutions (if not appropriately adjusted)
| Precautions | Risk of hemolysis and electrolyte imbalance when administered intravenously without addition of solutes; monitor for fluid overload and hyponatremia; caution in patients with impaired renal function, cardiac failure, or conditions predisposing to fluid retention. |
| Food/Dietary | No known food interactions. Sterile water for injection is intended for parenteral administration only and does not interact with dietary items. |
| Clinical Pearls | Sterile water for injection is hypotonic and must not be administered intravenously without first being made isotonic by admixture with appropriate solutes (e.g., dextrose, saline) to prevent hemolysis. It is used for reconstitution of powdered medications and for dilution of concentrated solutions. Always verify compatibility with other drugs before mixing. Use immediately after opening; discard any unused portion as it contains no preservatives. |
| Patient Advice | This product is sterile water; do not inject it directly into a vein unless mixed with other medications as directed. · It is used to dissolve or dilute other medicines before injection. · Your healthcare provider will prepare and administer this product; do not attempt to self-administer. · Tell your pharmacist or nurse if you have any allergies or medical conditions. · Store at room temperature; do not freeze. |
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