Acetic Acid

Baxter Healthcare Corporation

0.25% Acetic Acid Irrigation, USPin Plastic Pour Bottle

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACETIC ACID DESCRIPTION
• CLINICAL PHARMACOLOGY
• ACETIC ACID INDICATIONS AND USAGE
• ACETIC ACID CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Pregnancy
  • Pediatric Use
• ACETIC ACID ADVERSE REACTIONS
• ACETIC ACID DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

ACETIC ACID 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, (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 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.

ACETIC ACID 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.

ACETIC ACID CONTRAINDICATIONS

None known

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.

PRECAUTIONS

Pregnancy

Teratogenic Effects

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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming.

Do not administer unless the solution is clear and the seal is intact.

ACETIC ACID 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.

ACETIC ACID 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.

HOW SUPPLIED

0.25% Acetic Acid Irrigation, USP is supplied in a plastic pour bottle as follows:

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.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

07-19-63-439

Rev. February 2010

Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark Office.

*BAR CODE POSITION ONLY
071963439

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

0.25% Acetic Acid

Irrigation, USP

Pour Bottle

1000 ML

NDC 0338-0656-04
2F7184

EXP
LOT#

Qty 12

(01)50303380656047 (17)080630(10)G012345