Sterile Water

Description

Sterile Water for Injection, USP is a sterile, nonpyrogenic, solute-free preparation of distilled water intended for use solely 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 that incorporates 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 medication 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 prescribed additive must be mixed thoroughly using aseptic technique. It is important to note that the prepared solution should not be stored and should be used immediately after admixture.

Before administering parenteral drug products, a visual inspection for particulate matter and discoloration is essential. This inspection should be conducted whenever the solution and container permit, ensuring the safety and efficacy of the medication.

Contraindications

Administration of this product is contraindicated without the addition of a solute. Use without a solute may lead to adverse effects or reduced efficacy.

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 leading to congested states, including peripheral and pulmonary edema, is directly proportional to the electrolyte concentrations of these solutions.

Healthcare providers should be aware 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. Premature neonates are especially vulnerable due to their immature renal function and their requirement for large volumes 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 are at risk of accumulating aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur even at lower rates of administration. Therefore, careful monitoring of aluminum exposure and kidney function is essential in these populations to mitigate potential adverse effects.

Side Effects

Adverse reactions associated with the administration of this product may include a range of responses due to the technique of administration. Patients may experience a febrile response, infection at the injection site, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

Warnings regarding the use of this product emphasize that it is intended for drug diluent use only. Intravenous administration of sterile water for injection without additives may lead to hemolysis. Furthermore, the intravenous administration of sterile water for injection with additives can result in fluid and/or solute overload, leading to dilution of serum electrolyte concentrations, overhydration, congested states, and pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions, while the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

It is important to note that this product contains aluminum, which may be toxic. Prolonged parenteral administration of aluminum can lead to toxic levels, particularly in patients with impaired kidney function. Premature neonates are especially at risk due to their immature kidneys and their need 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, with tissue loading potentially occurring at even lower rates of administration.

Precautions should be taken to ensure that this product is not used 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). The solution should only be administered if it is clear and the container is undamaged; any unused portion should be discarded.

Contraindications include the administration of this product without the addition of a solute. In cases of overdosage, characterized by overhydration or solute overload, it is essential to re-evaluate the patient and implement appropriate corrective measures as outlined in the warnings.

Drug Interactions

Additives may exhibit incompatibility with certain medications. It is advisable to consult with a pharmacist to ensure safe and effective use of these substances. Monitoring for potential adverse effects is recommended when combining additives with other drugs.

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 the pediatric population 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 regarding dosage, as it is typically determined by age, weight, and clinical condition. While no specific recommendations or adjustments for geriatric patients are provided, healthcare providers should remain vigilant in assessing the individual needs of elderly patients when determining appropriate dosing.

The prescribing information does not indicate any particular safety concerns or special precautions for elderly patients. However, it is advisable for healthcare providers to monitor this population closely, given the potential for altered pharmacokinetics and pharmacodynamics in older adults. Regular evaluation of the patient's response to therapy and any emerging side effects is recommended to ensure optimal treatment outcomes.

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, taking into consideration the potential risks versus benefits.

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. 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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation of each patient's unique circumstances.

Overdosage

In cases of overdosage, particularly involving overhydration or solute overload, it is imperative 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 as a result.

Recommended Actions

Upon identification of overhydration or solute overload, healthcare professionals should implement appropriate corrective measures. These may include adjusting fluid intake, administering diuretics if indicated, and closely monitoring the patient's vital signs and laboratory values to ensure a return to homeostasis.

Potential Symptoms

Patients experiencing overdosage may present with a variety of symptoms, 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 essential components of effective management in these situations.

Nonclinical Toxicology

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

This product contains no more than 25 mcg/L of aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum greater than 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even 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

Reactions that may occur due to the technique of administration include febrile response, infection 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, and implement appropriate therapeutic countermeasures. If necessary, the remainder of the fluid should be saved for examination.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Injection is indicated solely as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced. It is crucial to inform patients that this product must not be administered without the addition of a solute, as it is intended 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 the intravenous administration of this product 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.

A warning should be issued regarding the presence of aluminum in this product, 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 the requirement 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 must 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 before administration, and any unused portion should be discarded.

Pregnant women should receive Sterile Water for Injection with additives only if clearly needed. The safety and effectiveness of this product in the pediatric population are based on the similarity of clinical conditions between pediatric and adult populations; however, providers should note that in neonates or very small infants, the volume of fluid may impact fluid and electrolyte balance.

In the event of an adverse reaction, healthcare providers should discontinue the infusion, evaluate the patient, 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 should be conducted, and appropriate corrective measures should be instituted.

Providers should remind patients that additives may be incompatible and to consult with a pharmacist if available. When introducing additives, aseptic technique should be employed, and the mixture should be thoroughly mixed and not stored. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever the solution and container permit. It is also important to check the flexible container's solution composition, lot number, and expiry date, and to avoid removing the solution container from its overwrap until immediately before use. Finally, the use of sterile equipment and aseptic technique is essential.

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, which further enhances its safety profile. The product is sterile and should be handled with care to maintain its sterility.

For optimal storage, it is recommended to keep the product at controlled room temperature, away from direct sunlight and moisture. Proper handling practices should be observed to prevent contamination and ensure the integrity of the sterile product.

Additional Clinical Information

The route of administration for the medication is intravenous. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

FDA Insert (PDF)

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

View full prescribing information (PDF)