Sterile Water

Description

Sterile Water for Injection, USP is a sterile, nonpyrogenic, solute-free preparation of distilled water intended solely for use as a sterile solvent or diluent vehicle for drugs or solutions suitable for parenteral administration. The pH of the solution is 5.5, with a permissible range of 5.0 to 7.0. This preparation contains no bacteriostat, antimicrobial agent, or added buffer and is designed for single-dose injection following admixture with an appropriate solute or solution. Any unused portion should be discarded when smaller amounts are required.

Chemically designated as H₂O, Sterile Water for Injection serves as a pharmaceutic aid and parenteral fluid replenisher after the addition of a suitable solute. The flexible container is constructed from a specially formulated non-plasticized film composed of polypropylene and thermoplastic elastomers (free flex® bag). The amount of water that may permeate from the container into the overwrap is insufficient to significantly affect the solution. However, solutions in contact with the flexible container may leach out certain chemical components of the container in very small amounts within the expiration period. The suitability of the container material has been validated through tests in animals in accordance with USP biological tests for plastic containers.

Uses and Indications

Sterile Water for Injection is indicated for use solely as a solvent or diluent vehicle for parenterally administered drugs or solutions. It may also serve as a source of water for parenteral fluid replenishment after suitable additives have been introduced.

There are no teratogenic or nonteratogenic effects associated with this product.

Dosage and Administration

The dosage of the drug is determined by the patient's age, weight, and clinical condition. Healthcare professionals should assess these factors to establish the appropriate dosing range for each individual patient.

Prior to administration, the drug must be mixed with any prescribed additives. It is essential to employ aseptic technique during this process to maintain sterility. The mixture should be thoroughly combined, and it is important to note that the prepared solution should not be stored for future use.

Before administering parenteral drug products, a visual inspection should be conducted to check for any particulate matter or discoloration, provided that the solution and container allow for such an assessment. This step is crucial to ensure the safety and efficacy of the drug being administered.

Contraindications

Administration of this product is contraindicated without the addition of a solute. This is due to the potential for adverse effects associated with the use of the product in its concentrated form.

Warnings and Precautions

The use of this product is strictly limited to drug diluent purposes. Intravenous administration of Sterile Water for Injection without any additives is contraindicated, as it may lead to hemolysis.

When administering sterile water for injection with additives, healthcare professionals must exercise caution due to the potential for fluid and/or solute overload. Such overload can result in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. It is important to note that the risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. Conversely, the risk of solute overload, which may lead to congested states characterized by peripheral and pulmonary edema, is directly proportional to the electrolyte concentrations of these solutions.

A critical warning pertains to the aluminum content of this product, which may pose a risk of toxicity. Prolonged parenteral administration of aluminum can lead to toxic levels, particularly in patients with impaired kidney function. This risk is heightened in premature neonates, whose immature kidneys are less capable of excreting aluminum. These patients often require substantial amounts of calcium and phosphate solutions that contain aluminum, making them particularly vulnerable.

Research indicates that patients with compromised kidney function, including premature neonates, who receive parenteral aluminum levels exceeding 4 to 5 mcg/kg/day are at risk of accumulating aluminum to levels associated with central nervous system and bone toxicity. Furthermore, tissue loading of aluminum may occur even at lower rates of administration.

Healthcare professionals are advised to monitor renal function and consider the cumulative aluminum exposure in patients receiving this product, especially in vulnerable populations such as premature neonates.

Side Effects

Adverse reactions associated with the administration of this product may vary in seriousness and frequency.

Reactions that may occur due to the technique of administration include febrile responses, infections at the site of injection, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia.

Warnings associated with intravenous administration highlight significant risks. The use of sterile water for injection without additives may lead to hemolysis. Furthermore, the intravenous administration of sterile water for injection with additives poses risks of fluid and/or solute overload, which can result in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions, while the risk of solute overload leading to congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

A critical warning is that this product contains aluminum, which may be toxic, particularly with prolonged parenteral administration in patients with impaired kidney function. Premature neonates are especially at risk due to their immature kidneys and the requirement for large amounts of calcium and phosphate solutions that contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral aluminum levels exceeding 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur even at lower rates of administration.

In cases of overhydration or solute overload, it is essential to re-evaluate the patient and implement appropriate corrective measures.

Drug Interactions

Additives may exhibit incompatibility with the drug product. It is advisable to consult with a pharmacist when considering the introduction of any additives. When additives are introduced, it is essential to employ aseptic techniques, ensure thorough mixing, and avoid storage of the mixture.

Parenteral drug products require careful visual inspection for particulate matter and discoloration prior to administration, whenever the solution and container allow for such evaluation. This practice is crucial to ensure the safety and efficacy of the drug being administered.

Packaging & NDC

The table below lists all NDC Code configurations of Sterile Water (water), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The safety and effectiveness of this product in pediatric patients are supported by the similarity of clinical conditions observed in both pediatric and adult populations.

In neonates and very small infants, careful consideration should be given to the volume of fluid administered, as it may impact fluid and electrolyte balance.

Additionally, this product contains no more than 25 mcg/L of aluminum, which is relevant for pediatric patients, particularly in the context of minimizing aluminum exposure.

Geriatric Use

Elderly patients may require careful consideration in dosing, as the dosage is typically dependent upon age, weight, and clinical condition. It is important to note that patients with impaired kidney function, including geriatric patients, may be at an increased risk for aluminum toxicity with prolonged parenteral administration.

Additionally, there is a concern regarding the risk of dilutional states and solute overload, which can lead to congested states characterized by peripheral and pulmonary edema. This risk is particularly pertinent in patients with reduced kidney function, a condition that may be more prevalent among the elderly population. Therefore, healthcare providers should closely monitor renal function and adjust dosages accordingly to mitigate these risks in geriatric patients.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with sterile water for injection. The potential effects of sterile water containing additives on fetal harm or reproduction capacity in pregnant patients are not known. Therefore, sterile water for injection with additives should be administered to a pregnant woman only if clearly needed. Healthcare professionals should weigh the potential benefits against any possible risks when considering the use of this product in pregnant patients.

Lactation

Nursing mothers should be aware of the potential for excretion of this medication in breast milk. There is an associated risk to breastfed infants when this medication is used during lactation. Caution is advised when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment may experience increased risk of aluminum toxicity due to the presence of aluminum in this product. Prolonged parenteral administration in individuals with reduced kidney function can lead to toxic levels of aluminum accumulation. This risk is particularly pronounced in premature neonates, whose immature kidneys are less capable of excreting aluminum, especially when they require large volumes of calcium and phosphate solutions that contain aluminum.

Clinical research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral aluminum at doses exceeding 4 to 5 mcg/kg/day are at risk of accumulating aluminum to levels associated with central nervous system and bone toxicity. Furthermore, tissue loading of aluminum may occur even at lower rates of administration. Therefore, careful monitoring and consideration of dosing adjustments are essential for patients with renal impairment to mitigate the risk of aluminum toxicity.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In cases of overdosage, particularly related to overhydration or solute overload, it is essential to conduct a thorough re-evaluation of the patient. This assessment should focus on identifying the extent of the overdosage and any associated symptoms that may arise.

Recommended Actions

Upon confirming an overdosage scenario, healthcare professionals are advised to implement appropriate corrective measures. These may include adjusting fluid intake, administering diuretics if indicated, and closely monitoring the patient's vital signs and laboratory parameters to ensure a return to homeostasis.

Potential Symptoms

Patients experiencing overdosage may present with symptoms related to fluid overload, which can include but are not limited to edema, hypertension, and electrolyte imbalances. It is crucial for healthcare providers to remain vigilant for these signs and to act promptly to mitigate any adverse effects.

Management Procedures

Management of overdosage should be tailored to the individual patient's needs, taking into account their clinical status and the severity of the overhydration or solute overload. Continuous monitoring and supportive care are paramount in ensuring patient safety and recovery.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with sterile water for injection. It remains unclear whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, sterile water for injection with additives should be administered to a pregnant woman only if clearly needed.

This product contains aluminum, which may pose a risk of toxicity. Prolonged parenteral administration of aluminum can lead to toxic levels, particularly in individuals with impaired kidney function. Premature neonates are especially vulnerable due to their immature kidneys and their need for large amounts of calcium and phosphate solutions that contain aluminum. Research indicates that patients with compromised kidney function, including premature neonates, who receive parenteral aluminum levels exceeding 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur even at lower rates of administration.

The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

Postmarketing Experience

Postmarketing experience has identified several reactions associated with the technique of administration. These include febrile responses, infections at the injection site, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia. In the event of an adverse reaction, it is recommended to discontinue the infusion, evaluate the patient, implement appropriate therapeutic countermeasures, and retain the remaining fluid for examination if necessary.

Additionally, it is important to note that this product contains aluminum, which may pose a risk of toxicity. Prolonged parenteral administration of aluminum can lead to toxic levels, particularly in patients with impaired kidney function. Research indicates that patients, including premature neonates, receiving parenteral aluminum at doses exceeding 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading of aluminum may occur even at lower rates of administration.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Injection is intended solely for single-dose injection after admixture with an appropriate solute or solution. It is crucial to inform patients that the product must not be administered without the addition of a solute and is designated for drug diluent use only.

Providers should emphasize the risks associated with intravenous administration of Sterile Water for Injection without additives, which may lead to hemolysis. Additionally, they should explain that intravenous administration with additives can result in fluid and/or solute overload, potentially causing dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions, while the risk of solute overload leading to congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

It is important to communicate that this product contains aluminum, which may be toxic, particularly with prolonged parenteral administration in patients with impaired kidney function. Premature neonates are at heightened risk due to their immature kidneys and their need for large amounts of calcium and phosphate solutions that contain aluminum. Providers should inform patients that research indicates that individuals with impaired kidney function, including premature neonates, who receive parenteral aluminum levels exceeding 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity, with tissue loading potentially occurring at even lower rates of administration.

Healthcare providers should instruct patients not to use Sterile Water for Injection for intravenous injection unless the osmolar concentration of additives totals at least 112 mOsmol/liter, which is two-fifths of the normal osmolarity of extracellular fluid (280 mOsmol/liter). They should also advise that the solution must be clear and the container undamaged prior to administration, and any unused portion should be discarded.

In the event of an adverse reaction, providers should counsel patients to discontinue the infusion, evaluate their condition, and implement appropriate therapeutic countermeasures, saving the remainder of the fluid for examination if necessary. If overhydration or solute overload occurs, a re-evaluation of the patient and appropriate corrective measures should be instituted.

Patients should be reminded that parenteral drug products should be visually inspected for particulate matter and discoloration before administration, whenever the solution and container permit. It is essential to check the flexible container's solution composition, lot number, and expiry date. Providers should instruct patients not to remove the solution container from its overwrap until immediately before use and to utilize sterile equipment and aseptic technique. They should also caution patients against using the solution if it appears cloudy or if a precipitate is present. Lastly, a warning should be issued that flexible containers should not be used in series connections.

Storage and Handling

Sterile Water for Injection, USP is supplied in a single-dose flexible plastic container. The container closure is designed without the use of natural rubber latex, ensuring compatibility for patients with latex sensitivities. Additionally, the container is constructed from non-PVC and non-DEHP materials, maintaining sterility throughout its use.

For optimal storage and handling, it is essential to keep the product in a controlled environment. Specific temperature ranges and conditions for storage are not provided; however, it is recommended to store the product in a cool, dry place away from direct sunlight and extreme temperatures to preserve its integrity.

Additional Clinical Information

The product is administered intravenously and should not be given without the addition of a solute. Clinicians must ensure that the osmolar concentration of any additives is at least 112 mOsmol/liter, which is two-fifths of the normal osmolarity of extracellular fluid (280 mOsmol/liter). It is essential to verify that the solution is clear and that the container is undamaged before administration; any unused portion should be discarded. Additionally, the product contains no more than 25 mcg/L of aluminum.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Sterile Water as submitted by Becton Dickinson and Company. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)