0.25% Acetic Acid Irrigation, USP in Plastic Pour Bottles
0.25% Acetic Acid Irrigation, USP, is a sterile, nonpyrogenic hypotonic solution for irrigation of the urinary bladder. Each 100 mL
contains 250 mg Glacial Acetic Acid, USP, (CH3COOH) in Water for Injection. pH 3.0 (2.8 to 3.4). Osmolarity: 42 mOsmol/L (calc.). No antimicrobial agent has been added.
The container is made from specially formulated polyolefin (PL 325). The polyolefin is a copolymer of ethylene and propylene. It
contains no plasticizers or other mobile additives. As a result, the container has virtually no extractability or leachability. The total extractables after two years of storage being
less than 0.01 ppm. It is also relatively impermeable to water vapor transmission and, therefore, requires no vapor barrier to maintain the proper drug concentration.
The minimal amount of acetic acid which may enter the systemic circulation is readily metabolized.
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.
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.
Pregnancy Category C
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.
Safety and effectiveness in pediatric patients have not been established.
Warm only in a water bath or oven heated to not more than 66°C.
Do not administer unless the solution is clear and the seal is intact.
Systemic acidosis, pain and hematuria have been reported in patients receiving urinary bladder irrigation with 0.2%. Acetic Acid
Should adverse reactions occur, discontinue the irrigation and reevaluate the clinical status of the patient.
DOSAGE AND ADMINISTRATION
The volume of solution needed will vary with nature and duration of the urologic procedure, according to physician’s instructions.
Parenteral drug products should he inspected visually for particulate matter and discoloration prior to administration whenever
solution and container permit.
0.25% Acetic Acid Irrigation, USP is supplied in a plastic pour bottle as follows:
2F7184 1000 mL NDC 0338-0656-04
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored
at room temperature (25%C): brief exposure up to 40ºC does not adversely affect the product.