Acetic Acid Irrigant

Acetic Acid Irrigant

Acetic Acid Irrigant Recall

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Questions & Answers

Side Effects & Adverse Reactions

FOR IRRIGATION ONLY. NOT FOR INJECTION.

  1. Use of this solution in patients with mucosal lesions of the urinary bladder may be harmful due to irritation of the lesions. Absorption via open lesions of the bladder mucosa may result in systemic acidosis.

  2. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

  3. Discard the unused portion of irrigating solution since it contains no preservative.

  4. Do not heat over 66°C (150°F).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

0.25% Acetic Acid Irrigation, USP, is a sterile, nonpyrogenic aqueous solution of Glacial Acetic Acid, USP for irrigation of the urinary bladder by the transurethral route (NOT FOR TUR). Each 100 mL contains 250 mg of Glacial Acetic Acid, in water for injection.

The solution is hypotonic, 42 mOsmol/liter (calc.), in relation to the extracellular fluid compartment of the body (280 mOsmol/liter) and has a pH of 3.1 (2.8 to 3.4).

Other than the active ingredient, acetic acid, the solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose irrigation. When smaller volumes are required the unused portion should be discarded.

The solution is a urinary bladder antimicrobial, acidifying irrigant.

Glacial Acetic Acid, USP is chemically designated acetic acid (C2H4O2) a liquid miscible with water. It has the following structural formula:

CH3COOH

Water for Injection is chemically designated H2O.

The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Acetic Acid Irrigant Manufacturers


  • Hospira, Inc.
    Acetic Acid Irrigant [Hospira, Inc.]
  • B. Braun Medical Inc.
    Acetic Acid Irrigant [B. Braun Medical Inc.]
  • Baxter Healthcare Corporation
    Acetic Acid Irrigant [Baxter Healthcare Corporation]

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