Neomycin Sulfate Solution for Irrigation

NEOSPORIN G.U. Irrigant 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. 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 S treptomyces fradiae . It has a potency equivalent to not less than 600 μg of neomycin per mg. The structural formulae are:

Polymyxin B sulfate, a polypeptide antibiotic, is the sulfate salt of polymyxin B1 and B2 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:

1-mL ampuls, boxes of 10 (NDC 61570-047-10) and 50 ampuls (NDC 61570-047-50); 20-mL multi-dose vial (NDC 61570-048- 20)

Store at 2° to 8°C (36° to 46°F).

Distributed by: Pfizer Inc., Newyork., NY 10017. Revised: Oct 2016.

No Information Provided

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

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 these drugs and following the oral and topical use of neomycin (see WARNINGS).

Read the entire FDA prescribing information for Neosporin-GU (Neomycin Sulfate Solution for Irrigation)