Sterile Water

Description

AQUALITE™ is a sterile water for irrigation, conforming to USP standards. The solution has a pH of approximately 5.5 and contains no antimicrobial or other added substances.

Uses and Indications

AQUALITE™ is indicated for intraperitoneal, irrigation, and topical use only. This drug is not intended for injection.

There are no teratogenic effects associated with AQUALITE™, and no nonteratogenic effects have been reported.

Dosage and Administration

The dosage of the product should be administered as directed by the healthcare professional. It is imperative that the container is not heated above 66°C to maintain the integrity of the formulation. Any unused portion of the product must be discarded to ensure safety and efficacy.

For optimal storage, the product should be kept at a temperature range of 20 to 25°C and must be protected from freezing to preserve its quality.

The route of administration is via irrigation. Healthcare professionals should ensure that the method of administration is performed in accordance with established protocols for irrigation procedures.

Contraindications

Use of this product is contraindicated in the following situations:

Heating the container above 66°C may compromise the integrity of the product and is therefore prohibited. Additionally, the product is not intended for injection, and such use is contraindicated.

Warnings and Precautions

This drug has not been evaluated by the FDA for safety and efficacy, and the labeling has not received FDA approval. Healthcare professionals should exercise caution when considering its use.

General precautions must be observed regarding the accuracy of barcode scanning systems. It is important to note that the barcode associated with this product may not register correctly on U.S. scanning systems. Therefore, institutions are advised to manually input the product into their systems to ensure that the barcode systems provide accurate information upon scanning. Alternative procedures should be implemented to confirm that the correct drug product is being utilized and administered to each patient.

Currently, there are no specific laboratory tests recommended for monitoring the use of this drug. Healthcare providers should remain vigilant and consider clinical judgment when assessing patient responses to treatment.

Side Effects

The available data for Sterile Water for Irrigation, USP does not specify any particular adverse reactions or side effects associated with its use. However, it is important to note that the product is labeled "FOR INTRAPERITONEAL, IRRIGATION AND TOPICAL USE ONLY • NOT FOR INJECTION." This labeling indicates that the product is not intended for injection, and misuse in this manner may pose potential risks to patients. Care should be taken to adhere to the specified routes of administration to avoid any complications.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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

There is no specific pediatric use information available for this medication, including recommended ages, dosing differences, safety concerns, or special precautions for children. Healthcare professionals should exercise caution when considering the use of this medication in pediatric patients due to the absence of relevant data.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety and efficacy of this drug during pregnancy have not been established, as it has not been approved by the FDA for any indication. The product is indicated solely for irrigation purposes and is not intended for injection. Given the lack of specific warnings, contraindications, or safety concerns related to its use during pregnancy, healthcare professionals should exercise caution when considering this product for pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes, particularly in the absence of clinical data supporting its use in this population. Women of childbearing potential should be informed of the current limitations in safety data when discussing treatment options.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the medication.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 outlined 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 prescribing information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In all instances of suspected overdose, healthcare professionals should ensure that appropriate measures are taken to safeguard the patient's health and well-being.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Adverse events and quality problems associated with the use of this product have been reported voluntarily through various channels. Healthcare professionals and consumers are encouraged to report any adverse events or quality issues to ICU Medical Global Complaint Management at (844) 654-7780 or via email at ProductComplaintsPP@icumed.com.

Additionally, reports can be submitted to the FDA's MedWatch Adverse Event Reporting Program. This can be done online at www.fda.gov/medwatch/report.htm, or through regular mail or fax. For mail or fax submissions, individuals may download the reporting form from www.fda.gov/MedWatch/getforms.htm or contact (800) 332-1088 to request a form. Completed forms should be returned to the address provided on the pre-addressed form or submitted by fax to (800) FDA-0178 (1-800-332-0178).

Patient Counseling

Healthcare providers should inform patients that this drug has not been found by the FDA to be safe and effective, and that this labeling has not received FDA approval. It is important to clarify that U.S. FDA-approved products are available by prescription only, while Canadian products may not carry the "Rx only" designation on their labeling.

Providers should advise institutions to manually input the product into their systems to ensure that barcode systems provide accurate information when the product is scanned. They should also emphasize the necessity of following alternative procedures to confirm that the correct drug product is being used and administered to individual patients.

Patients should be made aware of the process for reporting adverse events or quality problems associated with the use of this product. They can report such issues by calling ICU Medical Global Complaint Management at (844) 654-7780 or by emailing ProductComplaintsPP@icumed.com. Additionally, adverse events or quality problems can be reported to the FDA's MedWatch Adverse Event Reporting Program through online submission, regular mail, or fax.

Storage and Handling

The product is supplied in a single-use container. It is essential to store the product at a temperature range of 20 to 25°C (68 to 77°F) and to protect it from freezing. Care should be taken not to heat the container above 66°C. Any unused portion must be discarded after use.

Additional Clinical Information

The route of administration for the product is through irrigation. No additional information is available regarding laboratory tests, abuse potential, patient counseling, 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)