April 25, 2017
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Ciloxan Ophthalmic Solution

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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 organisms 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 subsp. anitratus
Aeromonas caviae

Aeromonas hydrophila

Brucella melitensis

Campylobacter coli

Campylobacter jejuni

Citrobacter diversus

Citrobacter freundii

Edwardsiella tarda

Enterobacter aerogenes

Enterobacter cloacae

Escherichia coli

Haemophilus ducreyi

Haemophilus parainfluenzae

Klebsiella pneumoniae

Klebsiella oxytoca

Legionella pneumophila

Moraxella (Branhamella) catarrhalis

Morganella morganii

Neisseria gonorrhoeae

Neisseria meningitidis

Pasteurella multocida

Proteus mirabilis

Proteus vulgaris

Providencia rettgeri

Providencia stuartii

Salmonella enteritidis

Salmonella typhi

Shigella sonneii

Shigella flexneri

Vibrio cholerae

Vibrio parahaemolyticus

Vibrio vulnificus

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, 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.

Animal Pharmacology

Ciprofloxacin and related drugs have been shown to cause arthropathy in immature animals of most species tested following oral administration. However, a one-month topical ocular study using immature Beagle dogs did not demonstrate any articular lesions.

Last reviewed on RxList: 3/6/2017
This monograph has been modified to include the generic and brand name in many instances.

Ciloxan Ophthalmic Solution - User Reviews

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