FDA Label for Acetic Acid
View Indications, Usage & Precautions
Acetic Acid Product Label
The following document was submitted to the FDA by the labeler of this product Baxter Healthcare Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Other
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.
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
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 40°C does not adversely affect the product.
Package Label - Principal Display Panel
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
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
* Please review the disclaimer below.