Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 0.25% Acetic Acid Irrigation USP is supplied sterile and nonpyrogenic in 1000 mL and 500 mL PIC™ (Plastic Irrigation Containers) packaged 16 per case. NDC Cat. No. Size 0.25% Acetic Acid Irrigation USP 0264-2304-00 R6600-01 1000 mL 0264-2304-10 R6601-01 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label 0.25% Acetic Acid Irrigation USP REF R6600-01 NDC 0264-2304-00 1000 mL PIC™ Container Rx only Each 100 mL contains: Glacial Acetic Acid USP 0.25 g Water for Injection USP qs pH: 3.1 (2.8–3.4) Calc. Osmolarity: 42 mOsmol/liter, hypotonic Not for Injection or Transurethral Surgery: Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single-dose container. Warning: Do not warm above 150°F (66°C). Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing. Dosage: See Prescribing Information. Rx only Not made with natural rubber latex, PVC or DEHP. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Lot Exp. Y37-002-526 LD-778-1 0.25% Acetic Acid Irrigation USP Principal Display Panel - 1000 mL Bag Label; PRINCIPAL DISPLAY PANEL - 500 mL Bag Label 0.25% Acetic Acid Irrigation USP REF R6601-01 NDC 0264-2304-10 500 mL PIC™ Container Rx only Each 100 mL contains: Glacial Acetic Acid USP 0.25 g Water for Injection USP qs pH: 3.1 (2.8–3.4) Calc. Osmolarity: 42 mOsmol/liter, hypotonic Not for Injection or Transurethral Surgery: Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single-dose container. Warning: Do not warm above 150°F (66°C). Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing. Dosage: See Prescribing Information. Rx only Not made with natural rubber latex, PVC or DEHP. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Lot Exp. Y37-002-527 LD-779-1 0.25% Acetic Acid Irrigation USP Principal Display Panel - 500 mL Bag Label
- HOW SUPPLIED 0.25% Acetic Acid Irrigation USP is supplied sterile and nonpyrogenic in 1000 mL and 500 mL PIC™ (Plastic Irrigation Containers) packaged 16 per case. NDC Cat. No. Size 0.25% Acetic Acid Irrigation USP 0264-2304-00 R6600-01 1000 mL 0264-2304-10 R6601-01 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
- PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label 0.25% Acetic Acid Irrigation USP REF R6600-01 NDC 0264-2304-00 1000 mL PIC™ Container Rx only Each 100 mL contains: Glacial Acetic Acid USP 0.25 g Water for Injection USP qs pH: 3.1 (2.8–3.4) Calc. Osmolarity: 42 mOsmol/liter, hypotonic Not for Injection or Transurethral Surgery: Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single-dose container. Warning: Do not warm above 150°F (66°C). Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing. Dosage: See Prescribing Information. Rx only Not made with natural rubber latex, PVC or DEHP. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Lot Exp. Y37-002-526 LD-778-1 0.25% Acetic Acid Irrigation USP Principal Display Panel - 1000 mL Bag Label
- PRINCIPAL DISPLAY PANEL - 500 mL Bag Label 0.25% Acetic Acid Irrigation USP REF R6601-01 NDC 0264-2304-10 500 mL PIC™ Container Rx only Each 100 mL contains: Glacial Acetic Acid USP 0.25 g Water for Injection USP qs pH: 3.1 (2.8–3.4) Calc. Osmolarity: 42 mOsmol/liter, hypotonic Not for Injection or Transurethral Surgery: Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single-dose container. Warning: Do not warm above 150°F (66°C). Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing. Dosage: See Prescribing Information. Rx only Not made with natural rubber latex, PVC or DEHP. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Lot Exp. Y37-002-527 LD-779-1 0.25% Acetic Acid Irrigation USP Principal Display Panel - 500 mL Bag Label
Overview
Each 100 mL contains: Glacial Acetic Acid USP 0.25 g Water for Injection USP qs pH: 3.1 (2.8-3.4) Calculated Osmolarity: 42 mOsmol/liter The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Glacial Acetic Acid USP CH 3 COOH 60.05 0.25% Acetic Acid Irrigation USP is a prediluted, sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. It contains no preservatives or added buffers. The solution is hypotonic. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. Not made with natural rubber latex, PVC or DEHP.
Indications & 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.
Dosage & Administration
As required for urologic irrigation. 0.25% Acetic Acid Irrigation USP may be administered by gravity drip via an administration set connected to an indwelling urethral catheter designed for continuous or intermittent two-way flow. For continuous or intermittent irrigation, the rate of administration will correspond roughly to the rate of urine flow and should be adjusted to maintain a urinary effluent pH of 4.5 to 5.0. Nitrazine or other pH paper may be used to monitor pH, preferably at least four times daily. Drip rate should be adjusted as necessary to maintain desired pH; increasing flow rate reduces pH value and vice versa. With continuous or intermittent irrigation, each patient will require a volume of approximately 500 to 1500 mL per 24 hours. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
WARNINGS FOR UROLOGIC IRRIGATION ONLY. 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. Do not warm above 150°F (66°C). After opening container, the contents should be used promptly in order to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservative.
Contraindications
0.25% Acetic Acid Irrigation USP is not for injection. This solution is contraindicated for irrigation during transurethral surgical procedures.
Adverse Reactions
Systemic acidosis, pain, and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% acetic acid solution. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination, if deemed necessary.
Storage & Handling
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
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