Neomycin and Polymyxin B Sulfates

INDICATIONS AND USAGE Neomycin and Polymyxin B Sulfates Solution for Irrigation is indicated for short-term use (up to 10 days) as a continuous irrigant or rinse in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters. Since organisms gain entrance to the bladder by way of, through, and around the catheter, significant bacteriuria is induced by bacterial multiplication in the bladder urine, in the mucoid film often present between catheter and urethra, and in other sites. Urinary tract infection may result from the repeated presence in the urine of large numbers of pathogenic bacteria. The use of closed systems with indwelling catheters has been shown to reduce the risk of infection. A three-way closed catheter system with constant neomycin-polymyxin B bladder rinse is indicated to prevent the development of infection while using indwelling catheters. If uropathogens are isolated, they should be identified and tested for susceptibility so that appropriate antimicrobial therapy for systemic use can be initiated.

DOSAGE AND ADMINISTRATION This preparation is specifically designed for use with “three-way catheters or with other catheter systems permitting continuous irrigation of the urinary bladder. The usual irrigation dose is 1 mL of Neomycin and Polymyxin B Sulfates Solution for Irrigation a day for up to 10 days. Using strict aseptic techniques, 1 mL of Neomycin and Polymyxin B Sulfates Solution for Irrigation should be added to a 1,000-mL container of isotonic saline solution. This container should then be connected to the inflow lumen of the “three-way” catheter which has been inserted with full aseptic precautions; use of a sterile lubricant is recommended during insertion of the catheter. The outflow lumen should be connected, via a sterile disposable plastic tube, to a disposable plastic collection bag. Stringent procedures, such as taping the inflow and outflow junction at the catheter, should be observed when necessary to insure the junctional integrity of the system. For most patients, the inflow rate of the 1,000-mL saline solution of neomycin and polymyxin B should be adjusted to a slow drip to deliver about 1,000 mL every 24 hours. If the patient’s urine output exceeds 2 liters per day, it is recommended that the inflow rate be adjusted to deliver 2,000 mL of the solution in a 24-hour period. It is important that the rinse of the bladder be continuous ; the inflow or rinse solution should not be interrupted for more than a few minutes. Preparation of the irrigation solution should be performed with strict aseptic techniques. The prepared solution should be stored at 4°C, and should be used within 48 hours following preparation to reduce the risk of contamination with resistant microorganisms.

CONTRAINDICATIONS Hypersensitivity to neomycin, the polymyxins, or any ingredient in the solution is a contraindication to its use. A history of hypersensitivity or serious toxic reaction to an aminoglycoside may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs of this class.

ADVERSE REACTIONS Neomycin occasionally causes skin sensitization when applied topically; however, topical application to mucus membranes rarely results in local or systemic hypersensitivity reactions. Irritation of the urinary bladder mucosa has been reported. Signs of ototoxicity and nephrotoxicity have been reported following parenteral use of drugs and following the oral and topical use of neomycin (see WARNINGS ). To report SUSPECTED ADVERSE REACTIONS, contact XGen Pharmaceuticals DJB, Inc. at 1-866-390-4411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION Neomycin and Polymyxin B Sulfates Solution for Irrigation, USP is a concentrated sterile antibiotic solution to be diluted for urinary bladder irrigation. Each mL contains neomycin sulfate equivalent to 40 mg neomycin base, 200,000 units polymyxin B sulfate, and Water for Injection, inactive ingredient: sulfuric acid. The 20-mL multiple dose vial contains, in addition to the above, 1 mg methylparaben (0.1%) added as a preservative. Neomycin sulfate, an antibiotic of the aminoglycoside group, is the sulfate salt of neomycin B and C produced by Streptomyces fradiae. It has a potency equivalent to not less than 600 mcg of neomycin per mg. The structural formulae are: Polymyxin B sulfate, a polypeptide antibiotic, is the sulfate salt of polymyxin B 1 and B 2 produced by the growth of Bacillus polymyxa. It has a potency of not less than 6,000 polymyxin B units per mg. The structural formulae are: C:\Documents and Settings\junem.X-GEN.000\Desktop\01.jpg J:\QA-RA\Regulatory Affairs\June\02.jpg

HOW SUPPLIED Neomycin and Polymyxin B Sulfates Solution for Irrigation, USP is supplied as: 1 mL/ampul (NDC 39822-1201-1) in boxes of 50 (NDC 39822-1201-5) and 20 mL Multiple Dose Vial in single Vial cartons (NDC 39822-1220-1). Store at 2° to 8°C (36° to 46°F). Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814 Made in India. Revised: February 2026 204001021 NP-PISG-00 XG DJB RX Only