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🇺🇸US · FDA ApprovedPrescriptionNDA018161-001

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

Manufacturer: B BRAUN

FDA Approval: 06/08/1979

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 0.25% Acetic Acid Irrigation USP is not for injection. This solution is contraindicated for irrigation during transurethral surgical procedures.

Warnings & Precautions

WARNINGS FOR UROLOGIC IRRIGATION ONLY. 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. Do not warm above 150°F (66°C). After opening container, the contents should be used promptly in order to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservative.

Adverse Reactions

ADVERSE REACTIONS Systemic acidosis, pain, and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% acetic acid solution. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination, if deemed necessary.

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.