Sterile Water

Description

Sterile Water for Injection, USP is a sterile, nonpyrogenic, solute-free preparation of distilled water intended for parenteral use. It serves as a sterile solvent or diluent vehicle for drugs or solutions suitable for injection. The pH of Sterile Water for Injection 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 exclusively for single-dose injection following admixture with an appropriate solute or solution. Any unused portion should be discarded when smaller amounts are utilized.

Chemically designated as H₂O, Sterile Water for Injection acts as a pharmaceutic aid and parenteral fluid replenisher upon the addition of a suitable solute. The product is packaged in a flexible plastic container made from a specially formulated polyvinylchloride. While water can permeate from the container into the overwrap, this occurs in negligible amounts that do not significantly affect the solution. Additionally, solutions within the plastic container may leach certain chemical components of the plastic in very small quantities before the expiration date. The safety of the plastic has been validated through animal testing in accordance with USP biological standards for plastic containers.

Uses and Indications

Sterile Water for Injection, USP is indicated for use solely as a solvent or diluent vehicle for parenterally administered drugs or solutions. Additionally, it serves as a source of water for parenteral fluid replenishment following the introduction of suitable additives.

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.

For the addition of medication, the following steps should be followed:

1. Prepare the additive port using aseptic technique.

2. Using an appropriate length additive delivery needle, puncture the resealable additive port at the target area, specifically the inner diaphragm, and inject the medication. Withdraw the needle after the injection is complete.

3. The additive port may be protected by covering it with an additive cap.

4. Mix the contents of the container thoroughly to ensure uniform distribution.

Preparation for administration should also adhere to aseptic technique and include the following steps:

1. Close the flow control clamp of the administration set.

2. Remove the cover from the outlet port located at the bottom of the container.

3. Insert the piercing pin of the administration set into the port with a twisting motion until the set is firmly seated. Refer to the full directions provided on the administration set carton for detailed instructions.

4. Suspend the container from a hanger.

5. Squeeze and release the drip chamber to establish the proper fluid level within the chamber.

6. Open the flow control clamp to clear air from the set, then close the clamp.

7. Attach the set to the venipuncture device. If the device is not indwelling, prime it and perform venipuncture.

8. Regulate the rate of administration using the flow control clamp to ensure appropriate delivery of the medication.

Contraindications

Administration of this product is contraindicated without the addition of a solute. This is essential to ensure proper formulation and efficacy.

Warnings and Precautions

The use of this product is strictly limited to drug diluent purposes. Intravenous administration of Sterile Water for Injection, USP, without any additives, poses a significant risk of hemolysis. Healthcare professionals must exercise caution when administering this solution.

When sterile water for injection is used with additives, there is a potential for fluid and/or solute overload. This can lead to 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 result in congested states accompanied 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 be toxic. Prolonged parenteral administration can lead to toxic levels of aluminum, particularly in patients with impaired kidney function. Premature neonates are especially vulnerable due to their immature renal function and their need 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 to levels associated with central nervous system and bone toxicity. Tissue loading may occur even at lower rates of administration.

Healthcare professionals are advised to monitor renal function closely in patients receiving this product, particularly in vulnerable populations such as premature neonates, to mitigate the risks associated with aluminum toxicity.

Side Effects

Adverse reactions associated with the administration of Sterile Water for Injection, USP may include both serious and common reactions.

Serious adverse reactions can occur due to the intravenous administration of sterile water for injection without additives, which may result in hemolysis. Additionally, the use of sterile water for injection with additives carries risks of fluid and/or solute overload, leading to dilution of serum electrolyte concentrations, overhydration, congested states, and pulmonary edema. Patients with impaired kidney function, particularly premature neonates, are at heightened risk for aluminum toxicity, which can occur with prolonged parenteral administration. Research indicates that aluminum levels exceeding 4 to 5 mcg/kg/day can lead to accumulation associated with central nervous system and bone toxicity, with tissue loading potentially occurring at even lower rates of administration.

Common reactions related to the technique of administration may include febrile responses, infections at the injection site, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia. In cases of overhydration or solute overload, it is essential to re-evaluate the patient and implement appropriate corrective measures.

The safety and effectiveness of this product in the pediatric population are inferred from the similarity of clinical conditions between pediatric and adult populations. However, in neonates or very small infants, the volume of fluid administered may significantly impact fluid and electrolyte balance.

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 refrain from storing 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 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 when prescribing this medication, as dosage is typically determined by factors such as age, weight, and clinical condition. While no specific information regarding geriatric use is provided in the prescribing information, healthcare providers should remain vigilant in assessing the individual needs of geriatric patients.

Due to the lack of explicit recommendations or dosage adjustments for this population, it is advisable for clinicians to monitor elderly patients closely for efficacy and safety. Adjustments may be necessary based on the patient's overall health status and response to treatment.

Pregnancy

Pregnant patients should be aware that sterile water for injection is classified as Pregnancy Category C. Animal reproduction studies have not been conducted with this product, and it remains unclear whether sterile water containing additives can cause fetal harm or affect reproductive capacity when administered to a pregnant woman. Therefore, sterile water for injection with additives should be given to pregnant women only if clearly needed, taking into consideration the potential risks versus benefits.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 accumulation and associated toxicities.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding 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.

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 range 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 scenarios.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with sterile water for injection, which is classified as Pregnancy Category C. It is unknown 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 given 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 safety of the plastic used in this product has been confirmed by tests in animals according to USP biological standards for plastic containers.

Postmarketing Experience

Reactions reported in the postmarketing experience 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.

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 may occur even at lower rates of administration.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Injection, USP is intended 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 emphasize that this product must not be administered without the addition of a solute, as intravenous administration of Sterile Water for Injection, USP without additives may lead to hemolysis.

Providers should inform patients that the intravenous administration of Sterile Water for Injection with additives carries the risk 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 causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

It is important to communicate the warning regarding aluminum content in this product, as prolonged parenteral administration may lead to toxic levels, particularly in patients with impaired kidney function. Premature neonates are especially at risk due to their immature kidneys and the need for large amounts of calcium and phosphate solutions, which contain aluminum. Providers should inform patients that research indicates that parenteral levels of aluminum exceeding 4 to 5 mcg/kg/day can accumulate to levels associated with central nervous system and bone toxicity.

Healthcare providers must stress that Sterile Water for Injection should not be used for intravenous injection unless the osmolar concentration of additives totals at least 112 mOsmol/liter. They should also instruct patients to ensure that the solution is clear and the container is undamaged before administration, discarding any unused portion.

Pregnant women should be informed that Sterile Water for Injection with additives should only be administered if clearly needed, as it is classified as Pregnancy Category C. 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, 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 advise patients to discontinue the infusion, evaluate the patient, and implement appropriate therapeutic countermeasures, saving the remainder of the fluid for examination if necessary. In cases of overhydration or solute overload, re-evaluation of the patient and appropriate corrective measures should be instituted.

Providers should also caution patients about the potential incompatibility of additives and recommend consulting with a pharmacist when available. When introducing additives, it is essential to use aseptic technique, mix thoroughly, and avoid storage of the mixture. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Finally, healthcare providers should warn patients against using flexible containers in series connections and advise them to store the product at 20 to 25°C (68 to 77°F), protecting it from freezing.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20 to 25°C (68 to 77°F), in compliance with USP Controlled Room Temperature guidelines. It is essential to protect the product from freezing to maintain its integrity and efficacy. Proper handling and storage conditions must be adhered to in order to ensure optimal performance.

Additional Clinical Information

The route of administration for the medication is intravenous. Clinicians are advised to consult with a pharmacist, if available, for guidance. When introducing additives, it is essential to use aseptic technique, ensure thorough mixing, and avoid storage of the mixture. 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 ICU Medical Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)