NEOSPORIN® G.U. Irrigant Sterile(neomycin sulfate–polymyxin
B sulfate solution for irrigation)
neomycin sulfate and
polymyxin b sulfate solution Monarch Pharmaceuticals, Inc.
NEOSPORIN® G.U. Irrigant Sterile (neomycin sulfate–polymyxin
B sulfate solution for irrigation)
NOT FOR INJECTION
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.
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 µg of neomycin
per mg. The structural formulae are:
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:
After prophylactic irrigation of the intact urinary bladder,
neomycin and polymyxin B are absorbed in clinically insignificant quantities.
A neomycin serum level of 0.1 µg/mL was observed in three of 33 patients
receiving the rinse solution. This level is well below that which has been
associated with neomycin-induced toxicity.
topically, polymyxin B sulfate and neomycin are rarely irritating.
Microbiology: The prepared
NEOSPORIN G.U. Irrigant Sterile solution is bactericidal. The aminoglycosides
act by inhibiting normal protein synthesis in susceptible microorganisms.
Polymyxins increase the permeability of bacterial cell wall membranes. The
solution is active in vitro against
Klebsiella and Enterobacter species
Neisseria species, and
It is not active in
vitro against Serratia marcescens and
Bacterial resistance may develop following
the use of the antibiotics in the catheter-rinse solution.
Indications and Usage
NEOSPORIN G.U. Irrigant 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.
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
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 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
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).
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.
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.
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.
Safety and effectiveness in pediatric patients have not
Neomycin occasionally causes skin sensitization when applied
topically; however, topical application to mucus membranes rarely results
in local or systemic hypersensitivity reactions.
of the urinary bladder mucosa has been reported.
Signsof ototoxicity and nephrotoxicity have been reported following parenteral
use of these drugs and following the oral and topical use of neomycin (see WARNINGS).
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
one 1-mL ampul a day for up to 10 days.
aseptic techniques, the contents of one 1-mL ampul of NEOSPORIN G.U. Irrigant
Sterile (neomycin sulfate-polymyxin B sulfate 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 recommendedthat the inflow rate be adjusted to deliver 2,000 mL of the solution in a
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.
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
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)