NEOSPORIN® GU IRRIGANT STERILE Warnings and Precautions (neomycin sulfate, polymyxin B sulfate)

WARNINGS

PROPHYLACTIC BLADDER CARE WITH NEOSPORIN G.U. IRRIGANT STERILE SHOULD NOT BE GIVEN WHERE THERE IS A POSSIBILITY OF SYSTEMIC ABSORPTION. NEOSPORIN G.U. IRRIGANT STERILE 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 NEOSPORIN G.U. Irrigant Sterile is low since no appreciable amounts of these antibiotics enter the systemic circulation by this route if irrigation does not exceed 10 days.

NEOSPORIN G.U. Irrigant 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 NEOSPORIN G.U. Irrigant Sterile is used during pregnancy, the patient should be apprised of the potential hazard to the fetus (see PRECAUTIONS).


PRECAUTIONS

General

Ototoxicity, nephrotoxicity, and neuromuscular blockade may occur if NEOSPORIN G.U. Irrigant 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 NEOSPORIN G.U. Irrigant 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 of organisms which are resistant to the bladder rinse antibiotics.

Pregnancy

Teratogenic Effects

See WARNINGS section.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Did you find an answer to your question? Yes No
Did you find an answer to your question? Yes No