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Name:Acetic Acid
Manufacturer:Baxter Healthcare Corporation
Category:Prescription Marketed Drugs


0.25% Acetic Acid Irrigation, USPin Plastic Pour Bottles

ACETIC ACID - acetic acid irrigant 
Baxter Healthcare Corporation

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0.25% Acetic Acid Irrigation, USP
in Plastic Pour Bottles

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. 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.

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.

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 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.

ADVERSE REACTIONS

Systemic acidosis, pain and hematuria have been reported in patients receiving urinary bladder irrigation with 0.2%. Acetic Acid Irrigation, USP.

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.

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.

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Printed in USA

©Copyright 1980, 1981, 1984, 1989, Baxter Healthcare Corporation.

All rights reserved.


ACETIC ACID 
acetic acid irrigant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0656
Route of Administration IRRIGATION DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Acetic Acid (Acetic Acid) Active 250 MILLIGRAM  In 100 MILLILITER
Water Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0338-0656-04 1000 mL (MILLILITER) In 1 BOTTLE None

Revised: 05/2006 Baxter Healthcare Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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