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.

ADVERSE REACTIONS SECTION.

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.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. The minimal amount of acetic acid which may enter the systemic circulation is readily metabolized.

DESCRIPTION SECTION.

DESCRIPTION. 0.25% Acetic Acid Irrigation, USP, is 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, 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 copolymer of ethylene and propylene. It contains no plasticizers or other mobile additives. As 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.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. The volume of solution needed will vary with nature and duration of the urologic procedure, according to physicians instructions.Irrigation drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

HOW SUPPLIED SECTION.

HOW SUPPLIED. 0.25% Acetic Acid Irrigation, USP is supplied in plastic pour bottle as follows:2F71841000 mLNDC 0338-0656-04Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25C): brief exposure up to 40oC does not adversely affect the product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL. Container LabelNot for Injection 2F7184NDC 0338-0656-040.25% Acetic AcidIrrigation, USP1000 mLEach 100 mL contains: 250 mg Glacial Acetic Acid, USP. No antimicrobial agent has been added. pH 3.0 (2.8 to 3.4). Osmolarity 42 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle. Hypotonic solution for irrigation only. Dosage and Administration: As directed by physician. See directions. Cautions: Warm in oven to not more than 50C for maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only. Recommended storage: Room temperature (25C). Avoid excessive heat. See insert.PL 325 plasticBaxter LogoBaxter Healthcare CorporationDeerfield, IL 60015 USAMade in USALOTEXP07-09-00-0251FPO(91)0709000251Bar CodeBar Code Posit ion Only(01) 00303380656042Carton Label0.25% Acetic AcidIrrigation, USPPour Bottle1000 MLNDC 0338-0656-04 2F7184EXP JUN 08 LOT G012345Qty 12(01)50303380656047 (17)080630(10)G012345. Acetic Acid Representative Container Label NDC 0338-0656-04. Acetic Acid Representative Carton Label NDC 0338-0656-04.

PEDIATRIC USE SECTION.

Pediatric Use. Safety and effectiveness in pediatric patients have not been established.Warm in oven to not more than 50C for maximum of 60 days. Discard after 60 days of warming.Do not administer unless the solution is clear and the seal is intact.

PRECAUTIONS SECTION.

PRECAUTIONS. 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 pregnant woman or can affect reproduction capacity. 0.25% Acetic Acid Irrigation, USP should be given to pregnant woman only if clearly needed.. Pediatric Use. Safety and effectiveness in pediatric patients have not been established.Warm in oven to not more than 50C for maximum of 60 days. Discard after 60 days of warming.Do not administer unless the solution is clear and the seal is intact.

PREGNANCY SECTION.

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 pregnant woman or can affect reproduction capacity. 0.25% Acetic Acid Irrigation, USP should be given to pregnant woman only if clearly needed.

SPL UNCLASSIFIED SECTION.

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 pregnant woman or can affect reproduction capacity. 0.25% Acetic Acid Irrigation, USP should be given to pregnant woman only if clearly needed.

TERATOGENIC EFFECTS SECTION.

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 pregnant woman or can affect reproduction capacity. 0.25% Acetic Acid Irrigation, USP should be given to pregnant woman only if clearly needed.

WARNINGS SECTION.

WARNINGS. 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.