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Ciloxan Ophthalmic Solution

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Ciloxan Ophthalmic Solution

Ciloxan Ophthalmic Solution

CLINICAL PHARMACOLOGY

Systemic Absorption: A systemic absorption study was performed in which CILOXAN Ophthalmic Solution was administered in each eye every two hours while awake for two days followed by every four hours while awake for an additional 5 days. The maximum reported plasma concentration of ciprofloxacin was less than 5 ng/mL. The mean concentration was usually less than 2.5 ng/mL.

Microbiology: Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA. Ciprofloxacin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections (SEE INDICATIONS AND USAGE section):

Gram-Positive

Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus pneumoniae

Streptococcus (Viridans Group)

Gram-Negative

Haemophilus influenzae

Pseudomonas aeruginosa

Serratia marcescens

Ciprofloxacin has been shown to be active in vitro against most strains of the following organisms, however, the clinical significance of these data is unknown:

Gram-Positive

Enterococcus faecalis (Many strains are only moderately susceptible)

Staphylococcus haemolyticus

Staphylococcus hominis

Staphylococcus saprophyticus

Streptococcus pyogenes

Gram-Negative    
Acinetobacter calcoaceticus Escherichia coli Proteus mirabilis
subsp. anitratus Haemophilus ducreyi Proteus vulgaris
Aeromonas caviae Haemophilus parainfluenzae Providencia rettgeri
Aeromonas hydrophila Kiebsiella pneumoniae Providencia stuartii
Brucella melitensis Klebsiella oxytoca Salmonella enteritidis
Campylobacter coli Legionella pneumophila Salmonella typhi
Campylobacter jejuni Moraxella (Branhamella) Shigella sonneii
Citrobacter diversus catarrhalis Shigella flexneri
Citrobacter freundii Morganella morganii Vibrio cholerae
Edwardsiella tarda Neisseria gonorrhoeae Vibrio parahaemolyticus
Enterobacter aerogenes Neisseria meningitidis Vibrio vulnificus
Enterobacter cloacae Pasteurella multocida Yersinia enterocolitica

Other Organisms: Chlamydia trachomatis (only moderately susceptible) and Mycobacterium tuberculosis (only moderately susceptible).

Most strains of Pseudomonas cepacia and some strains of Pseudomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile .

The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2. Resistance to ciprofloxacin in vitro usually develops slowly (multiple-step mutation).

Ciprofloxacin does not cross-react with other antimicrobial agents such as beta-lactams or aminoglycosides; therefore, organisms resistant to these drugs may be susceptible to ciprofloxacin.

CLINICAL STUDIES

Following therapy with CILOXAN Ophthalmic Solution (ciprofloxacin hcl ophthalmic solution) , 76% of the patients with corneal ulcers and positive bacterial cultures were clinically cured and complete re-epithelialization occurred in about 92% of the ulcers. In 3 and 7 day multicenter clinical trials, 52% of the patients with conjunctivitis and positive conjunctival cultures were clinically cured and 70-80% had all causative pathogens eradicated by the end of treatment.

Last reviewed on RxList: 3/28/2006
This monograph has been modified to include the generic and brand name in many instances.

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