NEOMYCIN AND POLYMYXIN B SULFATES- neomycin sulfate and polymyxin b sulfate solution
X-GEN Pharmaceuticals, Inc.
NOT FOR INJECTION
DESCRIPTION
Neomycin and Polymyxin B Sulfates Solution for Irrigation 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. 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. CLINICAL PHARMACOLOGY
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 mcg/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.
When used topically, polymyxin B sulfate and neomycin are rarely irritating.
Microbiology: The prepared Neomycin and Polymyxin B Sulfates Solution for Irrigation 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:
Escherichia coli
Staphylococcus aureus
Haemophilus influenzae
Klebsiella and Enterobacter species
Neisseria species, and
Pseudomonas aeruginosa.
It is not active in vitro against Serratia marcescens and streptococci.
Bacterial resistance may develop following the use of the antibiotics in the catheter-rinse solution.
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 one 1-mL ampul a day for up to 10 days.
Using strict aseptic techniques, the contents of one 1-mL ampul 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.
