{"adverse_reactions":["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":["CLINICAL PHARMACOLOGY The minimal amount of acetic acid which may enter the systemic circulation is readily metabolized."],"contraindications":["CONTRAINDICATIONS None known"],"description":["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, (CH 3 COOH) 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."],"dosage_and_administration":["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."],"effective_time":"20180202","how_supplied":["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."],"how_supplied_table":["
2F71841000 mLNDC 0338-0656-04
"],"id":"87782b03-c260-4e1d-b96e-8f5aa94411e2","indications_and_usage":["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."],"openfda":{"application_number":["NDA018523"],"brand_name":["Acetic Acid"],"generic_name":["ACETIC ACID"],"is_original_packager":[true],"manufacturer_name":["Baxter Healthcare Corporation"],"package_ndc":["0338-0656-04"],"product_ndc":["0338-0656"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["IRRIGATION"],"rxcui":["307707"],"spl_id":["87782b03-c260-4e1d-b96e-8f5aa94411e2"],"spl_set_id":["41bc12af-fac5-4ac1-b907-dcb3e35a054c"],"substance_name":["ACETIC ACID"],"unii":["Q40Q9N063P"]},"package_label_principal_display_panel":["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 LOT EXP 07-09-00-0251 FPO (91)0709000251 Bar Code Bar Code Posit ion Only* (01) 00303380656042 Acetic Acid Representative Container Label NDC 0338-0656-04"],"pediatric_use":["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."],"precautions":["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."],"pregnancy":["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."],"set_id":"41bc12af-fac5-4ac1-b907-dcb3e35a054c","spl_product_data_elements":["Acetic Acid Acetic Acid ACETIC ACID ACETIC ACID WATER"],"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"],"teratogenic_effects":["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."],"version":"13","warnings":["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."]}