Acetic Acid by Baxter Healthcare Corporation ACETIC ACID irrigant

Acetic Acid by

Drug Labeling and Warnings

Acetic Acid by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

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.

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.

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:

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.

SPL UNCLASSIFIED SECTION

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

Baxter is a registered trademark of Baxter International Inc.

07-19-00-0228

Rev. February 2018

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Container Label

Not for Injection 2F7184
NDC: 0338-0656-04

0.25% Acetic Acid
Irrigation, USP

1000 mL

Each 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 a physician. See
directions. Cautions: Warm in oven to not more than
50°C for a 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 (25°C).
Avoid excessive heat. See insert.

PL 325 plastic

Baxter Logo
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Made in USA

07-09-74-482

LOT
EXP

Bar Code Posit ion Only*
(01) 00303380656042

Carton Label

0.25% Acetic Acid
Irrigation, USP
Pour Bottle

1000 ML

NDC: 0338-0656-04 2F7184

EXP JUN 08 LOT# G012345

Qty 12

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

INGREDIENTS AND APPEARANCE

ACETIC ACID 
acetic acid irrigant

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-0656
Route of Administration	IRRIGATION

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)	ACETIC ACID	250 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-0656-04	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/19/1982

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018523	02/19/1982

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Corporation		001728059	MANUFACTURE(0338-0656) , ANALYSIS(0338-0656) , PACK(0338-0656) , LABEL(0338-0656) , STERILIZE(0338-0656)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Corporation		194684502	ANALYSIS(0338-0656)