Get your patient on Acetic Acid - Acetic Acid irrigant (Acetic Acid)
Acetic Acid - Acetic Acid irrigant prescribing information
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.
DOSAGE AND ADMINISTRATION
The volume of solution needed will vary with nature and duration of the urologic procedure, according to physician’s instructions.
Irrigation drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
CONTRAINDICATIONS
None known
ADVERSE REACTIONS
Systemic acidosis, pain and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% Acetic Acid Irrigation, USP.
Should adverse reactions occur, discontinue the irrigation and reevaluate the clinical status of the patient.
DESCRIPTION
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, (CH 3 COOH) in Water for Injection, USP. 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.
CLINICAL PHARMACOLOGY
The minimal amount of acetic acid which may enter the systemic circulation is readily metabolized.
HOW SUPPLIED
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.