Acetic Acid

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.

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

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.

General Use aseptic technique when preparing and administering sterile irrigation solutions. Use only if solution is clear and container and seal are intact. If pain or hematuria should occur during irrigation, it should be discontinued and the patient reevaluated. When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 0.25% Acetic Acid Irrigation USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. 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. Nursing Mothers Caution should be exercised when 0.25% Acetic Acid Irrigation USP is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of 0.25% Acetic Acid Irrigation USP have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Although systemic absorption of the product is unlikely, greater sensitivity of some older individuals cannot be ruled out.

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.

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.

Caution should be exercised when 0.25% Acetic Acid Irrigation USP is administered to a nursing woman.

Safety and effectiveness in pediatric patients have not been established.

Clinical studies of 0.25% Acetic Acid Irrigation USP have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Although systemic absorption of the product is unlikely, greater sensitivity of some older individuals cannot be ruled out.