ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Systemic acidosis has been reported in patients receivingurinary bladder irrigation with 0.25% acetic acid solution. Urologic painand hematuria have been reported in patients receiving urinary bladder irrigationwith 0.25% acetic acid solution.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Irrigation of the urinary bladder with acetic acid solutionin concentration of 0.25% has been shown to exert an antimicrobial actionagainst variety of microorganisms (especially ammonia-forming bacteria)that frequently gain access to the urinary bladder in patients who requireprolonged indwelling urethral catheterization. Its antimicrobial action isdependent on administration via the indwelling catheter at sufficient rate(continuous or intermittent) to maintain an effluent pH of at least 5.0. Maintenanceof low pH of bladder urine also helps reduce formation of calcium encrustationsin the indwelling catheter.

DESCRIPTION SECTION.

DESCRIPTION. 0.25% Acetic Acid Irrigation, USP, is sterile, nonpyrogenicaqueous solution of Glacial Acetic Acid, USP for irrigation of the urinarybladder by the transurethral route (NOT FOR TUR). Each 100 mL contains 250mg of Glacial Acetic Acid, in water for injection.Thesolution is hypotonic, 42 mOsmol/liter (calc.), in relation to the extracellularfluid compartment of the body (280 mOsmol/liter) and has pH of 3.1 (2.8to 3.4).Other than the active ingredient, acetic acid,the solution contains no bacteriostat, antimicrobial agent or added bufferand is intended only for use as single-dose irrigation. When smaller volumesare required the unused portion should be discarded.Thesolution is urinary bladder antimicrobial, acidifying irrigant.GlacialAcetic Acid, USP is chemically designated acetic acid (C2H4O2)a liquid miscible with water. It has the following structural formula:CH3COOHWaterfor Injection is chemically designated H2O.Thesemi-rigid container is fabricated from specially formulated polyolefin.It is copolymer of ethylene and propylene. The container requires no vaporbarrier to maintain the proper drug concentration.Solutionsin contact with the plastic container may leach out certain chemical componentsfrom the plastic in very small amounts; however, biological testing was supportiveof the safety of the plastic container materials.Exposureto temperatures above 25C/77F during transport and storage willlead to minor losses in moisture content. Higher temperatures lead to greaterlosses. It is unlikely that these minor losses will lead to clinically significantchanges within the expiration period.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. 0.25% Acetic Acid Irrigation, USP may be administered bygravity drip via an administration set connected to an indwelling urethralcatheter designed for continuous or intermittent two-way flow. disposabledispensing set should be used. bulb or piston syringe may be used for periodicirrigation of an indwelling catheter.For continuousor intermittent irrigation, the rate of administration will correspond roughlyto the rate of urine flow and should be adjusted to maintain urinary effluentpH of 4.5 to 5.0. Nitrazine or other pH paper may be used to monitor pH, preferablyat least four times daily. Drip rate should be adjusted as necessary to maintaindesired pH; increasing flow rate reduces pH value and vice versa. With continuousor intermittent irrigation, each patient will require volume of approximately500 to 1500 mL per 24 hours.For periodic irrigationof an indwelling catheter to maintain patency, about 50 mL is required foreach irrigation and may be administered using bulb or piston syringe forinjection and aspiration as often as desired.Parenteraldrug products should be inspected visually for particulate matter and discolorationprior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED SECTION.

HOW SUPPLIED. 0.25% Acetic Acid Irrigation, USP is supplied in single-dose irrigation containers as follows:ListContainerSize (mL)6143Semi-rigid250 1000Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25C (68 to 77F). [See USP Controlled Room Temperature.]Revised: October, 2004 (C)Hospira 2004 EN-0098 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USA.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. 0.25% Acetic Acid Irrigation, USP is indicated as 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.

OVERDOSAGE SECTION.

OVERDOSAGE. Systemic absorption is unlikely unless there are open lesionsof the bladder mucosa that have gone undetected. In such event, discontinuethe irrigation, evaluate the patient for possible systemic acidosis, intravascularhemolysis and circulatory overload and institute appropriate countermeasuresas indicated. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.OralLD50 in mice: g/kg.

PRECAUTIONS SECTION.

PRECAUTIONS. If pain or hematuria should occur during irrigation, it should be discontinued and the patient re-evaluated.Do not use unless solution is clear, seal is intact and container is undamaged. Discard unused portion.Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Acetic Acid Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.Nursing Mothers: Caution should be exercised when Acetic Acid Irrigation, USP is administered to nursing woman.Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Acetic Acid Irrigation, USP. It is also not known whether Acetic Acid Irrigation, USP can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Acetic Acid Irrigation, USP should be given to pregnant woman only if clearly needed.Pediatric Usage: The safety and effectiveness have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

SPL UNCLASSIFIED SECTION.

UROLOGIC IRRIGATING FLUIDFOR PATIENTS REQUIRING PROLONGED INDWELLING URETHRAL CATHETERIZATION...NOTFOR TRANSURETHRAL SURGICAL PROCEDURES.Not For Injection By Usual Parenteral RoutesSemi-Rigid Irrigation ContainerRx only.

WARNINGS SECTION.

WARNINGS. FOR IRRIGATION ONLY. NOT FOR INJECTION.Use of this solution in patients with mucosal lesions ofthe urinary bladder may be harmful due to irritation of the lesions. Absorptionvia open lesions of the bladder mucosa may result in systemic acidosis.The contents of an opened container should be used promptlyto minimize the possibility of bacterial growth or pyrogen formation.Discard the unused portion of irrigating solution since itcontains no preservative.Do not heat over 66C (150F).. Use of this solution in patients with mucosal lesions ofthe urinary bladder may be harmful due to irritation of the lesions. Absorptionvia open lesions of the bladder mucosa may result in systemic acidosis.. The contents of an opened container should be used promptlyto minimize the possibility of bacterial growth or pyrogen formation.. Discard the unused portion of irrigating solution since itcontains no preservative.. Do not heat over 66C (150F).