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Ciprofloxacin Hydrochloride [Ciloxan 0.3% 5ml]: Spectrum

Ciprofloxacin has a spectrum of activity similar to that of some other fluoroquinolones (e.g., norfloxacin, ofloxacin).

In vitro on a weight basis, the activity of ciprofloxacin is approximately equal to or slightly greater than that of ofloxacin against most susceptible organisms and is at least 2 times greater than that of norfloxacin against most susceptible organisms. Ciprofloxacin is active in vitro against most gram-negative aerobic bacteria, including Enterobacteriaceae and Pseudomonas aeruginosa.

Ciprofloxacin also is active in vitro against many gram-positive aerobic bacteria, including penicillinase-producing, nonpenicillinase-producing, and oxacillin-resistant staphylococci (previously known as methicillin-resistant staphylococci), although many strains of streptococci are relatively resistant to the drug. The drug generally is less active against gram-positive than gram-negative bacteria.

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Ciprofloxacin has some activity in vitro against obligately anaerobic bacteria, but many of these organisms are considered resistant to the drug. The drug also has some activity in vitro against Chlamydia, Mycoplasma, Mycobacterium, Plasmodium, and Rickettsia. Ciprofloxacin is inactive against fungi.

In Vitro Susceptibility Testing

Like those of other fluoroquinolones, results of ciprofloxacin in vitro susceptibility tests are affected by the pH of the media and the presence of certain cations (e.g., magnesium). There generally is little effect when the pH of the media is 6-8; however, MICs are at least 4-16 times greater when the pH of the media is less than 6.It has been suggested that ionization of the 7-piperazine group as pH decreases may interfere with access or binding to the drug's target enzyme.

Ciprofloxacin MICs also are increased when high concentrations of magnesium are present in the media. The mechanism by which magnesium interferes with the antibacterial activity of ciprofloxacin is unclear, but it has been suggested that this cation may form complexes with the drug which may prevent access or binding to its target enzyme. Presence of calcium or zinc does not appear to affect results of ciprofloxacin susceptibility tests. Inoculum size generally does not affect in vitro susceptibility to ciprofloxacin. MICs for most organisms are only 2-4 times greater when the size of the inoculum is increased from 102 to 108 colony-forming units (CFU) per mL; however, in some studies, an inoculum effect did occur with some strains of Enterobacteriaceae or Pseudomonas aeruginosa and MIC and MBC of the drug appeared to be equally affected by increased inoculum size.

Presence of serum generally has no effect on results of ciprofloxacin in vitro susceptibility tests, but reportedly may slightly decrease MICs of the drug for some organisms. MICs of ciprofloxacin are higher when susceptibility tests are performed in pooled urine or urine agar rather than in nutrient broth or Mueller-Hinton media. The MIC of ciprofloxacin for Escherichia coli is less than 0.01 mcg/mL in Mueller-Hinton broth at pH 7.4, but is 1.6 mcg/mL in urine at pH 7.5 or 6.5 and 3.1 mcg/mL in urine at pH 5.5. The decreased antibacterial activity in the presence of urine probably occurs because of low pH and because urine contains a higher concentration of magnesium ions than nutrient broth or Mueller-Hinton media. MICs of ciprofloxacin are increased when activated charcoal is present in the media.

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The National Committee for Clinical Laboratory Standards (NCCLS) states that, if results of in vitro susceptibility testing indicate that a clinical isolate is susceptible to ciprofloxacin, then an infection caused by this strain may be appropriately treated with the dosage of the drug recommended for that type of infection and infecting species, unless otherwise contraindicated. If results indicate that a clinical isolate has intermediate susceptibility to ciprofloxacin, then the strain has a minimum inhibitory concentration (MIC) that approaches usually attainable blood and tissue concentrations and response rates may be lower than for strains identified as susceptible.

Therefore, the intermediate category implies clinical applicability in body sites where the drug is physiologically concentrated or when a high dosage of the drug can be used. This intermediate category also includes a buffer zone which should prevent small, uncontrolled technical factors from causing major discrepancies in interpretation, especially for drugs with narrow pharmacotoxicity margins.

If results of in vitro susceptibility testing indicate that a clinical isolate is resistant to ciprofloxacin, the strain is not inhibited by systemic concentrations of the drug achievable with normal dosage schedules and/or MICs fall in the range where specific microbial resistance mechanisms are likely and efficacy has not been reliable in clinical studies.

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Results of ciprofloxacin susceptibility tests should not be used to predict susceptibility to other fluoroquinolones.

Disk Susceptibility Tests

When the disk-diffusion procedure is used to test susceptibility to ciprofloxacin, a disk containing 5 mcg of ciprofloxacin should be used. When the disk-diffusion susceptibility test is performed according to NCCLS standardized procedures, Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter, Staphylococci, or Enterococcus with growth inhibition zones of 21 mm or greater are susceptible to ciprofloxacin, those with zones of 16-20 mm have intermediate susceptibility, and those with zones of 15 mm or less are resistant to the drug.

Although fecal isolates of Salmonella and Shigella may be tested for in vitro susceptibility to fluoroquinolones, strains of Salmonella that appear susceptible to fluoroquinolones but are resistant to nalidixic acid (no longer commercially available in the US) may be associated with clinical failure or delayed response in patients with extraintestinal salmonellosis.

Therefore, testing extraintestinal Salmonella isolates for in vitro susceptibility to nalidixic acid (no longer commercially available in the US) may be considered. When disk-diffusion susceptibility testing is performed according to NCCLS standardized procedures using Haemophilus Test Medium (HTM), Haemophilus with growth inhibition zones of 21 mm or greater are considered susceptible to ciprofloxacin. Because of limited data on resistant strains of these organisms, NCCLS recommends that any Haemophilus isolate that appears to be nonsusceptible to ciprofloxacin be submitted to a reference laboratory for further testing. When susceptibility of Neisseria gonorrhoeae is tested using NCCLS standardized procedures and GC agar base (with 1% defined growth supplement), those with growth inhibition zones of 41 mm or greater are susceptible to ciprofloxacin, those with zones of 28-40 mm have intermediate susceptibility, and those with zones of 27 mm or less are resistant to the drug.

Dilution Susceptibility Tests

When dilution susceptibility testing (agar or broth dilution) is performed according to NCCLS standardized procedures, Enterobacteriaceae, Ps. aeruginosa, and other non-Enterobacteriaceae gram-negative bacilli (e.g., Acinetobacter, Stenotrophomonas maltophilia, other Pseudomonas spp) with MICs of 1 mcg/mL or less are susceptible to ciprofloxacin, those with MICs of 2 mcg/mL have intermediate susceptibility, and those with MICs of 4 mcg/mL or greater are resistant to the drug.

Although fecal isolates of Salmonella and Shigella may be tested for in vitro susceptibility to fluoroquinolones, strains of Salmonella that appear susceptible to fluoroquinolones but are resistant to nalidixic acid may be associated with clinical failure or delayed response in patients with extraintestinal salmonellosis. Therefore, testing extraintestinal Salmonella isolates for in vitro susceptibility to nalidixic acid may be considered. When dilution susceptibility testing is performed according to NCCLS standardized procedures to test susceptibility of Staphylococci or Enterococcus to ciprofloxacin, those with MICs of 1 mcg/mL or less are susceptible to ciprofloxacin, those with MICs of 2 mcg/mL have intermediate susceptibility, and those with MICs of 4 mcg/mL or greater are resistant to the drug.

Because staphylococci may develop resistance to fluoroquinolones during prolonged therapy, isolates that are initially susceptible may become resistant within 3-4 days after initiation of therapy; therapy, repeated testing of isolates may be warranted. When broth dilution susceptibility testing of Haemophilus is performed according to NCCLS standardized procedures using HTM, Haemophilus with MICs of 1 mcg/mL or less are considered susceptible to ciprofloxacin. Because of limited data on resistant strains of these organisms, NCCLS recommends that any Haemophilus isolate that appears to be nonsusceptible to ciprofloxacin be submitted to a reference laboratory for further testing.

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When susceptibility of Neisseria gonorrhoeae is tested using NCCLS standardized procedures and GC agar base, N. gonorrhoeae with MICs of 0.06 mcg/mL or less are susceptible to ciprofloxacin, those with MICs of 0.12-0. mcg/mL have intermediate susceptibility, and those with MICs of 1 mcg/mL or greater are resistant to the drug.

Gram-positive Aerobic Bacteria

Gram-positive Aerobic Cocci

Ciprofloxacin is active in vitro against most strains of Staphylococcus aureus, S. epidermidis, S. saprophyticus, and S. hemolyticus. The drug is active against both penicillinase-producing and nonpenicillinase-producing staphylococci, and also is active in vitro against some oxacillin-resistant strains, although to a lesser degree than against oxacillin-susceptible strains.

Ciprofloxacin is less active in vitro on a weight basis against streptococci than against staphylococci. Streptococcus pneumoniae, S. pyogenes (group A b-hemolytic streptococci), S. agalactiae (group B streptococci), and viridans streptococci generally are inhibited in vitro by ciprofloxacin concentrations of 4 mcg/mL or less. Groups C, F, and G streptococci and nonenterococcal group D streptococci are inhibited in vitro by ciprofloxacin concentrations of 16 mcg/mL or less. Ciprofloxacin is active in vitro against some strains of enterococci, including Enterococcus faecalis (formerly S. faecalis). The drug is more active in vitro against E. faecalis than against E. faecium or E. durans (formerly S. faecium and S. durans, respectively).

Ciprofloxacin is bactericidal in vitro against enterococci and is active against some strains of E. faecalis resistant to penicillin combined with an aminoglycoside. The following table includes MIC50s (minimum inhibitory concentrations of the drug at which 50% of strains tested are inhibited) and MIC90s (minimum inhibitory concentrations of the drug at which 90% of strains tested are inhibited) of ciprofloxacin reported for gram-positive aerobic cocci: Organism MIC50 (mcg/mL) MIC90 (mcg/mL)

  • Staphylococcus aureus 0.06-0.5 0.12-2
  • S. epidermidis 0.06-0.25 0.125-1
  • S. saprophyticus 0.13-0. 0.25-0.5
  • Oxacillin-resistant S. 0.12-0.78 0.13-4 aureus
  • Streptococcus pneumoniae 0.5-2 1-4
  • S. pyogenes (group A 0.5-1 1-4 b-hemolytic streptococci)
  • S. agalactiae (Group B 0.5-1 0.8-4 streptococci Groups C, F, and G 0.05-2 0.4-16 streptococci
  • Viridans streptococci 0.5-2 0.5-4
  • Nonenterococcal group D 1-2 1-6.3 streptococci
  • Enterococci 0.5-4 0.5-8

Gram-positive Aerobic Bacilli

Ciprofloxacin is active in vitro against Bacillus anthracis, and naturally occurring isolates have been inhibited in vitro by ciprofloxacin concentrations of 0.03-0.25 mcg/mL. The MIC of the drug reported for the strain of B. anthracis used in a study in the rhesus monkey model of inhalational anthrax was 0.08 mcg/mL. Results of in vitro susceptibility testing of 11 B. anthracis isolates that were associated with cases of inhalational or cutaneous anthrax that occurred in the US (Florida, New York, District of Columbia) during September and October 2001 in the context of an intentional release of anthrax spores (biologic warfare, bioterrorism) indicate that these strains had ciprofloxacin MICs of 0.06 mcg/mL or less.

Based on interpretive criteria established for staphylococci, these strains are considered susceptible to ciprofloxacin. Anti-infectives are active against the germinated form of B. anthracis but are not active against the organism while it is still in the spore form. Strains of B. anthracis with naturally occurring resistance to ciprofloxacin have not been reported to date.

However, reduced susceptibility to ofloxacin (4-fold increase in MICs from baseline) has been produced in vitro following sequential subculture of the Sterne strain of B. anthracis in subinhibitory concentrations of the fluoroquinolone. There are published reports of B. anthracis strains that have been engineered to have tetracycline and penicillin resistance as well as resistance to other anti-infectives (e.g., macrolides, chloramphenicol, rifampin).

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Ciprofloxacin is active in vitro against Corynebacterium. The MIC90 of the drug reported for JK strains of Corynebacterium and Corynebacterium D2102 is 0.5-1 mcg/mL. Ciprofloxacin is active in vitro against Listeria monocytogenes, and the MIC90 of the drug reported for this organism is 0.25-2 mcg/mL. The MIC90 of ciprofloxacin for Nocardia asteroides is 8-16 mcg/mL; these organisms generally are considered resistant to the drug.

Gram-negative Aerobic Bacteria

Neisseria

Ciprofloxacin is active in vitro against Neisseria meningitidis and most strains of penicillinase- and nonpenicillinase-producing N. gonorrhoeae. The drug also is active in vitro against N. gonorrhoeae with chromosomally mediated resistance to penicillin (CMRNG) or plasmid-mediated tetracycline resistance (TRNG). The MIC90 of ciprofloxacin is 0.004-0.06 mcg/mL for N. meningitidis and 0.002-0.05 mcg/mL for most penicillinase- or nonpenicillinase-producing N. gonorrhoeae, CMRNG, and TRNG. However, strains of N. gonorrhoeae with decreased susceptibility to ciprofloxacin and other fluoroquinolones have been reported. To date, most strains of N. gonorrhoeae with reduced susceptibility to ciprofloxacin have MICs of 0.05-0.25 mcg/mL; however, strains with ciprofloxacin MICs of 1-2 mcg/mL also have been reported. (See Resistance.)

Haemophilu

Ciprofloxacin is active in vitro against b-lactamase- and non-b-lactamase-producing Haemophilus influenzae, and the MIC90 of the drug for these organisms is 0.008-0.05 mcg/mL. Ciprofloxacin is active in vitro against strains of b-lactamase-producing H. influenzae that are resistant to chloramphenicol. The MIC90 of ciprofloxacin for H. parainfluenzae and H. ducreyi is 0.03 mcg/mL.

Moraxella catarrhalis

Ciprofloxacin is active in vitro against both b-lactamase- and non-b-lactamase-producing strains of Moraxella catarrhalis, and the MIC90 of the drug reported for this organism is 0.015-0. mcg/mL.

Enterobacteriaceae

Ciprofloxacin is active in vitro against most clinically important Enterobacteriaceae, and the MIC90 of the drug for most of these organisms is 1 mcg/mL or less. While ciprofloxacin is active against Shigella dysenteriae type 1, the MIC of the drug for this strain generally is several-fold higher than for other Shigella strains. Ciprofloxacin is active in vitro against some Enterobacteriaceae resistant to aminoglycosides and/or b-lactam antibiotics.

The following table includes MIC50s and MIC90s of ciprofloxacin reported for Enterobacteriaceae: Organism MIC50 (mcg/mL) MIC90 (mcg/mL)

  • Citrobacter spp. 0.01-0.03 0.01-0.13
  • C. diversus 0.01-0.06 0.01-0.25
  • C. freundii 0.01-0.13 0.03-1
  • Edwardsiella tarda 0.06 0.06
  • Enterobacter spp. 0.01-0.06 0.02-0.
  • E. agglomerans 0.01-0.03 0.02-0.13
  • E. cloacae 0.01-0.06 0.03-1.
  • E. aerogenes 0.01-0.06 0.03-0.
  • Escherichia coli 0.01-0.16 0.02-0.13
  • Hafnia alvei 0.01-0.03 0.01-0.13
  • Klebsiella spp. 0.01-0.08 0.06-1
  • K. oxytoca 0.01-0.06 0.03-0.
  • K. pneumoniae 0.01-0.08 0.06-0.5
  • Morganella morganii 0.01-0.06 0.02-0.13
  • Proteus mirabilis 0.02-0.06 0.02-0.125
  • P. vulgaris 0.02-0.06 0.02-0.
  • Providencia rettgeri 0.02-0.5 0.06-2
  • P. stuartii 0.03-2 0.13-8
  • Serratia spp. 0.03-0. 0.06-2
  • S. marcescens 0.03-0. 0.06-6.25
  • Salmonella spp. 0.01-0.03 0.01-0.
  • S. enteritidis 0.01 0.02
  • S. typhi 0.01-0.1 0.02-0.1
  • Shigella spp. 0.01-0.02 0.01-0.06
  • Yersinia enterocolitica 0.01-0.1 0.01-0.1

Pseudomonas

Ciprofloxacin is active in vitro against most strains of Ps. aeruginosa and also has some activity against some other Pseudomonas. The MIC50 and MIC90 of ciprofloxacin for Ps. aeruginosa are 0.06-1 and 0.03-4 mcg/mL, respectively.

Ciprofloxacin is active in vitro against some strains of Ps. aeruginosa that are resistant to aminoglycosides, extended-spectrum penicillins, and cephalosporins. The MIC90 of the drug for Ps. fluorescens and Ps. putida is 0.25-4 mcg/mL; however, the MIC90 for Ps. cepacia (Burkholderia cepacia), Stenotrophomonas maltophilia (formerly Xanthomonas or Ps. maltophilia), and Ps. pseudomallei is 0.05-16 mcg/mL and many of these organisms are considered resistant to the drug.

Vibrio

Ciprofloxacin is active in vitro against Vibrio cholerae and V. parahaemolyticus, and the MIC90 of the drug reported for these organisms is 0.008-0.25 mcg/mL.

Other Gram-negative Aerobic Bacteria

The MIC90 of ciprofloxacin for Acinetobacter lwoffi (A. calcoaceticus subsp. lwoffi) and A. baumannii (A. calcoaceticus subsp. anitratus) is 0.125-4 mcg/mL. Aeromonas hydrophila, A. caviae, A. sobria, and Plesiomonas shigelloides generally are inhibited in vitro by ciprofloxacin concentrations of 0.1 mcg/mL or less. The MIC90 of ciprofloxacin reported for Alcaligenes, including A. faecalis, is 1.4-12.5 mcg/mL.

Ciprofloxacin is active in vitro against strains of Campylobacter coli, C. fetus, and Helicobacter pylori (formerly C. pylori or C. pyloridis). The MIC90 of the drug for some strains of Campylobacter fetus subsp. jejuni, an organism that can be microaerophilic or anaerobic, is 0.12-0.62 mcg/mL. The MIC90 of the drug reported for H. pylori is 0.25-0.5 mcg/mL, and the MIC90 for C. coli is 0.39 mcg/mL.

However, fluoroquinolone-resistant strains of Campylobacter have been reported in areas with widespread use or prolonged therapy with the drugs. (See Resistance.) Brucella melitensis, Pasteurella multocida, Eikenella corrodens, and Flavobacterium generally are inhibited by ciprofloxacin concentrations of 0.01-1 mcg/mL. Ciprofloxacin has in vitro activity against Francisella tularensis. In one study evaluating susceptibility of F. tularensis isolated from humans and animals, the MIC of ciprofloxacin for this organism was 0.016 mcg/mL.

Ciprofloxacin has in vitro activity against Yersinia pestis. In a study of Y. pestis isolates obtained from plague patients, rats, or fleas from Vietnam, the organism was inhibited in vitro by ciprofloxacin concentrations of 0.008-0.062 mcg/mL. In addition, ciprofloxacin has been shown to have in vivo activity against Y. pestis in murine plague infections. However, mutant strains of Y. pestis resistant to ciprofloxacin have been selected in vitro. Some strains of Gardnerella vaginalis (formerly Haemophilus vaginalis) are inhibited in vitro by ciprofloxacin concentrations of 0.5-8 mcg/mL. The MIC90 of ciprofloxacin reported for Legionella pneumophila, L. bozemanii, L. dumoffii, L. gormanii, L. jordanis, L. longbeachae, L. micdadei (the Pittsburgh pneumonia agent), and L. wadsworthii is 0.01-0.5 mcg/mL.

Anaerobic Bacteria

Ciprofloxacin has some activity against gram-positive and gram-negative anaerobic bacteria; however, high concentrations of the drug generally are required for in vitro inhibition and many of these organisms are considered resistant to the drug. The MIC90 of ciprofloxacin for Actinomyces, Bifidobacterium, Peptococcus, and Peptostreptococcus is 0.5-8 mcg/mL.

Some strains of Clostridium perfringens may be inhibited in vitro by ciprofloxacin concentrations of 0.5-1 mcg/mL, but most Clostridium, including C. difficile, require ciprofloxacin concentrations of 4-32 mcg/mL or greater for in vitro inhibition and are considered resistant to the drug. The MIC90 for Eubacterium is 1-16 mcg/mL. The MIC90 of ciprofloxacin for Propionibacterium acnes and Veillonella is 0.12-4 mcg/mL, and the MIC90 for Fusobacterium is 2-16 mcg/mL.

Although some strains of Bacteroides are susceptible to ciprofloxacin, most strains are considered resistant to the drug. The MIC90 of ciprofloxacin for Bacteroides fragilis is 0.8-32 mcg/mL. The MIC90 of ciprofloxacin for B. melaninogenicus, B. ovatus, B. uniformis, and B. ureolyticus is 0.25-16 mcg/mL and the MIC90 of the drug for B. distasonis, B. oralis (Prevotella oralis), B. thetaiotaomicron, and B. vulgatus generally is 16-64 mcg/mL.

Chlamydia and Mycoplasma

Ciprofloxacin has some in vitro activity against Chlamydia trachomatis, C. pneumoniae, and C. psittaci, and these organisms generally are inhibited in vitro by concentrations of 0.5-5 mcg/mL. The MBC of ciprofloxacin reported for C. trachomatis is 1-10 mcg/mL. The MIC90 of ciprofloxacin reported for Mycoplasma hominis and M. pneumoniae is 0.5-2 mcg/mL. In some studies, the MIC90 of ciprofloxacin for Ureaplasma urealyticum was 2-6.3 mcg/mL; however, in other studies, this organism was resistant to the drug since the MIC90 was 32 mcg/mL and the MBC was greater than 64 mcg/mL.

Mycobacterium

Although the clinical importance has not been determined, ciprofloxacin is active in vitro against some Mycobacterium. In vitro on a weight basis, ciprofloxacin is more active than norfloxacin or ofloxacin against these organisms. The MIC90 of ciprofloxacin forM. tuberculosis is 0.1-3.1 mcg/mL. Other mycobacteria usually are less susceptible to ciprofloxacin. The MIC90 for M. fortuitum, M. kansasii, M. smegmatis, and M. xenopi is 0.05-8 mcg/mL. The MIC90 for M. avium complex, M. abscessus, and M. chelonae generally is 1-16 mcg/mL; most strains of M. abscessus and M. chelonae are considered resistant to ciprofloxacin. Ciprofloxacin exhibited weak activity against M. leprae in an in vitro metabolic screen for potential antileprosy agents that measured intracellular ATP of the bacteria, and no more than a limited bacteriostatic effect in an in vivo mouse footpad study in mice receiving up to 150 mg/kg of the drug daily.

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Other Organisms

Ciprofloxacin has some activity in vitro against Plasmodium falciparum. In some studies, the drug appeared to be active against both chloroquine-susceptible and -resistant strains of the organism. However, in other studies, chloroquine-resistant strains required high concentrations of the drug for in vitro inhibition.

When in vitro activity of ciprofloxacin was assessed using incorporation of radiolabeled hypoxanthine by the organism, the ID50 (concentration of the drug required to inhibit hypoxanthine uptake by 50%) of ciprofloxacin for chloroquine-susceptible P. falciparum was 3.2 mcg/mL and the ID50 of the drug for chloroquine-resistant strains was 6.6 mcg/mL. Ciprofloxacin reportedly has some activity in vitro against Rickettsia conorii, the causative organism of Mediterranean spotted fever. In one study, the MIC of the drug for this organism was 0.5 mcg/mL. Although further study is needed, results of one study indicate that ciprofloxacin may have some activity in vitro against Leptospira interrogans.

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