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Acetic Acid Irrigation
  • Professionals
  • FDA PI

Acetic Acid Irrigation

Dosage form: irrigation
Drug class:Topical anti-infectives

Medically reviewed by Drugs.com. Last updated on May 23, 2022.

UROLOGIC IRRIGATING FLUID FOR PATIENTS REQUIRING PROLONGED INDWELLING URETHRAL CATHETERIZATION...NOT FOR TRANSURETHRAL SURGICAL PROCEDURES.

Not For Injection By Usual Parenteral Routes

Semi-Rigid Irrigation Container

Rx only

Acetic Acid Irrigation Description

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 Irrigation - Clinical Pharmaco...