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CiprobayCiprobay

Broad-spectrum antibiotic

Composition
Active constituent:
Ciprobay 250:
1 film-coated tablet contains 291 mg ciprofloxacin hydrochloride monohydrate, corresponding to 250 mg ciprofloxacin.
Ciprobay 500:
1 film-coated tablet contains 582 mg ciprofloxacin hydrochloride monohydrate, corresponding to 500 mg ciprofloxacin.
Ciprobay 750:
1 film-coated tablet contains 873 mg ciprofloxacin hydrochloride monohydrate, corresponding to 750 mg ciprofloxacin.

Further constituents:
microcrystalline cellulose, maize starch, poly(1-vinyl-2-pyrrolidone) crosslinked, highly dispersed silicon dioxide, magnesium stearate, methylhydroxypropylcellulose, macrogol 4000, titanium dioxide (E171).

Properties
Ciprofloxacin is a synthetic broad spectrum quinolone antibacterial agent. (ATC code: J01MA02)

Mechanism of Action
Ciprofloxacin has in-vitro against virtually all Gram-negative and Gram-positive organisms. The bactericidal action of ciprofloxacin results from inhibition of bacterial type II topoisomerases (DNA gyrase and topoisomerase IV), which are required for bacterial DNA replication, transcription, repair, and recombination.

Mechanism of Resistance
In vitro resistance to ciprofloxacin is commonly due to mutations in bacterial topoisomerases and develops slowly through multiple-step mutations. Ciprofloxacin resistance due to spontaneous mutations occurs at a frequency of between <10-s to 10-6. Cross-resistance among fluoroquinolones may occur when resistance arises through mutations. Single mutations may result in reduced susceptibility rather than clinical resistance, but multiple mutations generally result in clinical resistance to ciprofloxacin and cross-resistance across the quinolone class. Bacterial impermeability and/or expression of efflux pumps may impact ciprofloxacin susceptibility. Plasmid-mediated resistance encoded by the gnrgene has been reported. Resistance mechanisms that inactive penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines do not interfere with the antibacterial activity of ciprofloxacin and there is no known cross-resistance between ciprofloxacin and other classes of antimicrobials. Organisms resistant to these drugs may be susceptible to ciprofloxacin.

The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2.

In vitro Susceptibility Testing
Interpretative criteria for the susceptibility testing of ciprofloxacin approved by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are presented in the below table.

European Committee on Antimicrobial Susceptibility Testing (EUCAST)

Clinical MIC (µg/L) Breakpoints for Ciprofloxacin

Organism

Susceptible

[mg/L]

Resistant

[mg/L]

Enterobacteriaceae

Pseudomonas

Staphylococcus1

Streptococcus pneumoniae2

Haemophilus influenzae and Moraxella catarrhalis3

Neisseria gonorrhoeae

Non-species related breakpoints4

≤0.5

≤0.5

≤1

≤0.125

≤0.5

≤0.03

≤0.5

>1

>1

>1

>2

>0.5

>0.06

>1

1. Staphylococcus spp. - breakpoints for ciprofloxacin and ofloxacin relate to high dose therapy.
2. Streptococcus pneumoniae - wild type S. pneumoniae are not considered susceptible to ciprofloxacin or ofloxacin and are therefore categorized as intermediate.
3. Strains with MIC values above the S/I breakpoint are very rare or not yet reported. The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory. Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint (in italics) they should be reported resistant. Haemophilus/ Moraxella-fluoroquinolone low-level resistance (ciprofloxacin MICs of 0.125 - 0.5 mg/L) may occur in Haemophilus influenzae. There is no evidence that low-level resistance is of clinical importance in respiratory tract infections with H. influenzae.
4. Non-species related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species. They are for use only for species that have not been given a species-specific breakpoint and not for those species where susceptibility testing is not recommended (marked with - or IE in the table).


Clinical and Laboratory Standards Institute™ (CLSI, formerly NCCLS) breakpoints are presented in the below table for MIC testing (mg/L) or disk diffusion testing (zone diameter [mm]) using a 5 µg ciprofloxacin disk.


Clinical and Laboratory Standards Institute™ (CLSI)
MIC (µg/L) and Disk Diffusion (mm) Breakpoints (CLSI Document M100-S17, 2007)

Organism

Susceptible

Intermediate

Resistant

Enterobacteriaceae

<1a

>21b

2a

16-20b

>4a

<15b

Pseudomonas aeruginosa and

other non-Enterobacteriaceae

<1a

>21b

2a

16-20b

>4a

<15b

Staphylococcus spp

<1a

>21b

2a

16-20b

>4a

<15b

Enterococcus spp.

<1a

>21b

2a

16-20b

>4a

<15b

Haemophilus spp.

<1c

>21d

--

--

--

--

Neisseria gonorhoeae

<0.06e

<41e

0.12 - 0.5e

28 - 40e

>1e

<27e

a This interpretive standard is applicable only to broth dilution tests using cation adjusted Mueller-Hinton broth (CAMHB) incubated in ambient air at 33 to 35°C (do not exceed 35°C) for 16 - 20 hours
b This interpretive standard is applicable only to disc diffusion tests using Mueller-Hinton agar incubated in ambient air at 33 to 35°C (do not exceed 35°C) for 16 -18 hours
c This interpretive standard is applicable only to broth dilution susceptibility tests with Haemophilus influenzae and Haemophilus parainfluenzae using Haemophilus test medium (HTM) broth incubated in ambient air at 35°C ± 2°C for 20 - 24 hours
d This interpretive standard is applicable only to disk diffusion tests with H. influenzae and H. parainfluenzae using HTM incubated in 5% CO2 at 35°C ± 2°C for 16 -18 hours
e This interpretive standard is applicable only to agar based susceptibility tests using GC agar and 1% defined growth supplement at 36 ± 1°C (not to exceed 37°C) in 5% CO2 for 20 - 24 hours.


Influence of Test Conditions
Inoculum size has only a slight effect on in vitro susceptibility testing in the presence of very high numbers), whereas growth media and oxygen tension have no significant influence. Ciprofloxacin is slightly less active when tested under acidic pH conditions.

 

In vitro Susceptibility to Ciprofloxacin
The prevalence of acquired resistance may vary geographically and with time for selected species and local information of resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought where the local prevalence of resistance is such that utility of the agent, in at least some types of infections, is questionable.

 

Ciprofloxacin has been shown to be active in vitro against susceptible strains of the micro-organisms listed below:

Aerobic Gram-positive Microorganisms
Bacillus anthracis  
Enterococcus faecalis (many strains are only moderately susceptible)
Staphylococcus aureus (methicillin-susceptible)
Staphylococcus saprophyticus  
Streptococcus pneumoniae  
Aerobic Gram-negative Microorganisms
Burkholderia cepacia Morganella morganii
Campylobacter spp. Neisseria gonorrhoeae
Citrobacter freudii Proteus mirabilis
Enterobacter aerogenes Proteus vulgaris
Enterobacter clocae Providencia spp.
Escherichia coli Peudomonas aeruginosa
Haemophilius influenzae Pseudomonas fluorescens
Klebsiella pneumoniae Serratia marcescens
Klebsiella oxytoca Shigella spp.
Moraxella catarrhalis  

The following microorganisms show varying degrees of susceptibility to ciprofloxacin:

Burkholderia cepacia, Campylobacter spp., Enterococcus faecalis, Morganella morganii, Nesseria gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Serratia marcescens.

 

The following microorganisms are considered inherent / resistant to ciprofloxacin:

Staphylococcus aureus (methicillin-resistant) and Stenotrophomonas maltophilia.


Ciprofloxacin has been shown to be active against Bacillus anthracis both in vitro and by use of serum levels as a surrogate marker.

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