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🇺🇸US · FDA ApprovedPrescriptionNDA018523-001

ACETIC ACID 0.25% IN PLASTIC CONTAINER(ACETIC ACID, GLACIAL)

Manufacturer: BAXTER HLTHCARE

FDA Approval: 19/02/1982

Route: IRRIGATION, URETHRAL · SOLUTION

Indications & Usage

INDICATIONS AND USAGE 0.25% Acetic Acid Irrigation, USP, is indicated as a constant or intermittent bladder rinse to help prevent the growth and proliferation of susceptible urinary pathogens (especially ammonia forming bacteria) in the management of patients who require prolonged placement of an indwelling urethral catheter. It also may be used for periodic irrigation of an indwelling catheter to help maintain patency by reducing the formation of calcium encrustations.

Contraindications

CONTRAINDICATIONS None known

Warnings & Precautions

WARNINGS Not for injection. Use of this solution in patients with mucosal lesions of the urinary bladder may be harmful due to irritation of the lesion. Absorption via open lesions of the bladder mucosa may result in systemic acidosis. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.

Adverse Reactions

ADVERSE REACTIONS Systemic acidosis, pain and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% Acetic Acid Irrigation, USP. Should adverse reactions occur, discontinue the irrigation and reevaluate the clinical status of the patient.

Use in Pregnancy & Lactation

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with 0.25% Acetic Acid Irrigation, USP. It is also not known whether 0.25% Acetic Acid Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.25% Acetic Acid Irrigation, USP should be given to a pregnant woman only if clearly needed.

Active Ingredients

ACETIC ACID, GLACIAL 250MG/100ML

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Medical disclaimer: This drug information is intended for qualified healthcare professionals only. Always verify with the official FDA prescribing information before clinical use.