Neomycin and Polymyxin B Sulfates

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.

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.

PROPHYLACTIC BLADDER CARE WITH NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION FOR IRRIGATION SHOULD NOT BE GIVEN WHERE THERE IS A POSSIBILITY OF SYSTEMIC ABSORPTION. NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION SHOULD NOT BE USED FOR IRRIGATION OTHER THAN FOR THE URINARY BLADDER. Systemic absorption after topical application of neomycin to open wounds, burns, and granulating surfaces is significant and serum concentrations comparable to and often higher than those attained following oral and parenteral therapy have been reported. Absorption of neomycin from the denuded bladder surface has been reported. However, the likelihood of toxicity following topical irrigation of the intact urinary bladder with Neomycin and Polymyxin B Sulfates Solution for Irrigation is low since no appreciable amounts of these antibiotics enter the systemic circulation by this route if irrigation does not exceed 10 days. Neomycin and Polymyxin B Sulfates Solution for Irrigation is intended for continuous prophylactic irrigation of the lumen of the intact urinary bladder of patients with indwelling catheters. Patients should be under constant supervision by a physician. Irrigation should be avoided in patients with defects in the bladder mucosa or bladder wall, such as vesical rupture, or in association with operative procedures on the bladder wall, because of the risk of toxicity due to systemic absorption following diffusion into absorptive tissues and spaces. When absorbed, neomycin and polymyxin B are nephrotoxic antibiotics, and the nephrotoxic potentials are additive. In addition, both antibiotics, when absorbed, are neurotoxins: neomycin can destroy fibers of the acoustic nerve causing permanent bilateral deafness; neomycin and polymyxin B are additive in their neuromuscular blocking effects, not only in terms of potency and duration, but also in terms of characteristics of the blocks produced. Aminoglycosides, when absorbed, can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta and there have been several reports of total, irreversible, bilateral, congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. If Neomycin and Polymyxin B Sulfates Solution for Irrigation is used during pregnancy, the patient should be apprised of the potential hazard to the fetus (see PRECAUTIONS ).

General Ototoxicity, nephrotoxicity, and neuromuscular blockade may occur if Neomycin and Polymyxin B Sulfates Solution for Irrigation ingredients are systemically absorbed (see WARNINGS ). Absorption of neomycin from the denuded bladder surface has been reported. Patients with impaired renal function, infants, dehydrated patients, elderly patients, and patients receiving high doses of prolonged treatment are especially at risk for the development of toxicity. Irrigation of the bladder with Neomycin and Polymyxin B Sulfates Solution for Irrigation may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs. The safety and effectiveness of the preparation for use in the care of patients with recent lower urinary tract surgery have not been established. Urine specimens should be collected during prophylactic bladder care for urinalysis, culture, and susceptibility testing. Positive cultures suggest the presence or organisms which are resistant to the bladder rinse antibiotics. Pregnancy Teratogenic Effects Pregnancy Category D. See WARNINGS section. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

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.

Teratogenic Effects Pregnancy Category D. See WARNINGS section.

Safety and effectiveness in pediatric patients have not been established.