NEOMYCIN AND POLYMYXIN B SULFATES- neomycin and polymyxin b sulfates irrigant

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Actavis Pharma, Inc.

INN (International Name):

NEOMYCIN SULFATE

Sammensetning:

NEOMYCIN 40 mg in 1 mL

Administreringsrute:

IRRIGATION

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 susceptibi

Produkt oppsummering:

Sterile Neomycin and Polymyxin B Sulfate Solution for Irrigation is available in 1 mL ampules, cartons of 10 and 50. Refrigerate at 2°-8° C (36°-46° F). Literature Revised: August 2010 Product No.: 0801-81 Manufactured by: Hikma Farmaceutica (Portuagal) S.A. 2705-906 Terrugem SNT, Portugal Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA                                                    PIN228-WAT/1

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

NEOMYCIN AND POLYMYXIN B SULFATES- NEOMYCIN AND POLYMYXIN B SULFATES
IRRIGANT
ACTAVIS PHARMA, INC.
----------
NEOMYCIN AND POLYMYXIN B SULFATES
SOLUTION FOR IRRIGATION USP
NOT FOR INJECTION
RX ONLY
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.
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 600µg 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
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.
When used topically, polymyxin B sulfate and neomycin are rarely
irritating.
MICROBIOLOGY: The prepared Neomycin and Polymyxin B Sulfates Solution
for Irrigation 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
_Escherichia coli_
_Staphylococcus aureus_
_Haemophilus influenzae_
_Klebsiella andEnterobacter sepecies_
_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.
INDI