Revision Year: 2020 Publisher: LABORATOIRE INNOTECH INTERNATIONAL, 22 AVENUE ARISTIDE BRIAND, 94110 ARCUEIL
Pharmacotherapeutic group: ANTIINFECTIVES and ANTISEPTICS IN GYNECOLOGICAL USE (G. genitourinary system and sex hormones)
ATC code: G01AA51
Combination of neomycin, polymyxin B and nystatin.
Neomycin is an aminoside antibiotic.
Polymyxin B is a polypeptide antibiotic.
Nystatin is an antifungal with anticandida activity.
Critical concentrations separate sensitive strains from strains with intermediate sensitivity and the latter from resistant ones: S ≤2 mg/l and R >2 mg/l.
The prevalence of acquired resistance may vary with geographical location and time for certain species. It is therefore useful to have information on the prevalence of local resistance, in particular when treating severe infections. These data can only be used as an orientation for the probabilities of sensitivity of a bacterial strain to this antibiotic.
When the variability of the prevalence of resistance is known in France for a bacterial species, it is provided in the following table:
| Categories | Frequency of acquired resistance in France (>10%) (limit values) |
|---|---|
| SENSITIVE SPECIES Aerobic Gram-negative bacteria Acinetobacter Aeromonas Alcaligenes Citrobacter freundii Citrobacter koseri Enterobacter Escherichia coli Klebsiella Moraxella Pseudomonas aeruginosa Salmonella Shigella Stenotrophomonas maltophilia | 0–30% |
| RESISTANT SPECIES Aerobic Gram-positive bacteria Cocci and bacilli Aerobic Gram-negative bacteria Branhamella catarrhalis Brucella Burkholderia cepacia Burkholderia pseudomallei Campylobacter Chryseobacterium meningosepticum Legionella Morganella Neisseria Proteus Providencia Serratia Vibrio cholerae El Tor Anaerobic Cocci and bacilli Others Mycobacteria |
The prevalence of acquired resistance may vary with geographical location and time for certain species. It is therefore useful to have information on the prevalence of local resistance, in particular when treating severe infections. These data can only be used as an orientation for the probabilities of sensitivity of a bacterial strain to this antibiotic.
When the variability of the prevalence of resistance is known in France for a bacterial species, it is provided in the following table:
| Categories | Frequency of acquired resistance in France (>10%) (limit values) |
|---|---|
| SENSITIVE SPECIES Aerobic Gram-positive bacteria Corynebacterium Listeria monocytogenes Staphylococcus meti-S Aerobic Gram-negative bacteria Acinetobacter (essentially Acinetobacter baumanii) Branhamella catarrhalis Campylobacter Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Salmonella Serratia Shigella Yersinia | 50–75% 20–25% ? 10–20% 15–25% 25–35% 10–15% 10–20% 20–50% ? ? ? ? ? ? |
| MODERATELY SENSITIVE SPECIES (in vitro of intermediate sensitivity) Aerobic Gram-negative bacteria Pasteurella | |
| RESISTANT SPECIES Aerobic Gram-positive bacteria Enterococci Nocardia asteroides Staphylococcus meti-R∗ Streptococcus Aerobic Gram-negative bacteria Alcaligenes denitrificans Burkholderia Flavobacterium sp. Providencia stuartii Pseudomonas aeruginosa Stenotrophomonas maltophilia Anaerobic Strictly anaerobic bacteria Others Chlamydia Mycoplasmas Rickettsias |
∗ The frequency of resistance to methicillin is approximately 30 to 50% of all staphylococci and is encountered mainly in hospitals.
Remark: these spectra correspond to those of the systemic forms of these antibiotics. With local pharmaceutical presentations, concentrations obtained in situ are much higher than plasma concentrations. There is some remaining uncertainty concerning kinetics of in situ concentrations, local physicochemical conditions which can alter the antibiotic activity and product stability in situ.
There is no systemic absorption when the product is administered by vaginal route.
Local tolerance in animals with Polygynax does not show any harmful effect on the vaginal mucosa.
Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate, neomycin and nystatin.
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