NEOMYCIN AND POLYMYXIN B SULFATES solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)

Available from:

XGen Pharmaceuticals DJB, Inc.

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN 40 mg in 1 mL

Administration route:

IRRIGATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Neomycin and Polymyxin B Sulfates Solution for Irrigation are supplied as 1 mL/ampul (NDC 39822-1201-1) in boxes of 10 (NDC 39822-1201-2), 50 (NDC 39822-1201-5) and 20 mL Multiple Dose Vial in single Vial cartons (NDC 39822-1220-1). Store at 2° to 8°C (36° to 46°F). Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814 Revised: December 2020 NP-PI-04

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES- NEOMYCIN AND POLYMYXIN B
SULFATES SOLUTION
XGEN PHARMACEUTICALS DJB, INC.
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NEOMYCIN AND POLYMYXIN B SULFATES
SOLUTION FOR IRRIGATION, USP
RX ONLY
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. The structural formulae are:
Polymyxin B sulfate, a polypeptide antibiotic, is the sulfate salt of
polymyxin B
and B
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
2
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 vitr