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Tsipromed in the treatment of infectious eye diseases

DV Katz Department of Ophthalmology of medical faculty, Russian State Medical University, Moscow Literary review presents data of efficacy and safety of Cipromed usage both in monotherapy and in comparison with other topical antibacterial drugs.

Fluoroquinolones were synthesized by introducing one, two or three fluorine atoms into the naphthyridine quinolone molecule. In their properties, they differ significantly from non-fluorinated derivatives for the better. Fluoroquinolones have a broad antimicrobial spectrum of action, high bioavailability, good pharmacokinetic properties and low toxicity. All fluoroquinolones have a single mechanism of action - inhibition of the bacterial enzyme DNA gyrase (topoisomerase II), which determines the processes of DNA biosynthesis and cell division. Fluoroquinolones have a fairly pronounced post-antibiotic effect (the antimicrobial effect continues after the drug is removed from the environment). The duration of the post-antibiotic effect is determined by the type of microorganism and the value of the previously effective concentration. In the form of a 0.3% solution, ciprofloxacin is widely used to treat a number of eye infections resulting from eye surgery and penetrating eye injuries. Ciprofloxacin is active in vitro against Staphylococcus and Bacillus strains, as well as most gram-negative microorganisms, including Pseudomonas strains. Activity of ciprofloxacin against gram-negative bacteria and staphylococcus (minimum inhibitory concentration (MIC), mg/l): Citrobacter spp. 0.008–0.03 Enterobacter spp. 0.03–0.06 E. coli 0.004–2 Klebsiella spp. 0.06–0.25 Proteus spp. 0.03 Salmonella spp. 0.015–0.25 Shigella spp. 0.015–0.25 H. influenzae 0.008–0.032 P. aeruginosa 0.25–2 S. aureus 0.25–1 Streptococcus spp. 0.5–8. In addition, ciprofloxacin has sufficient activity against gram-positive cocci - group A, B, C streptococci, Streptococcus faecalis, P. aeruginosa; chlamydia and mycoplasma. When 0.3% ciprofloxacin was prescribed, punctate superficial keratitis was 26.1%, precipitate deposition – 11.1%, irritation – 11.1% [16]. Less than 1% and more than 0.1% of patients experienced such atypical manifestations of side effects as: the appearance of crusts on the edges of the eyelids, dry eye syndrome, discharge, keratitis, lacrimation, photophobia, pain, decreased vision, chemosis, infiltrates corneas, blurred vision, allergic reaction, swelling of the eyelids, conjunctival hyperemia, numbness, conjunctivitis, pinpoint erosion of the epithelium. Clinical data obtained from the use of ciprofloxacin in general practice made it possible to develop a form for use in ophthalmology - a 0.3% solution of ciprofloxacin in the form of eye drops (Tsipromed). The drug Tsipromed is used for infectious and inflammatory diseases of the eyes (acute and subacute conjunctivitis, blepharitis, blepharoconjunctivitis, keratitis, keratoconjunctivitis, bacterial corneal ulcer, chronic dacryocystitis, meibomitis (barley), for infectious eye lesions after trauma or foreign bodies), in order to prevent – and postoperative prevention of infectious complications in ophthalmic surgery. Recommended use of Tsipromed for mild and moderately severe infections: instill 1-2 drops into the conjunctival sac of the affected eye every 4 hours, for severe infections - 2 drops every hour. After the condition improves, the dose and frequency of instillations are reduced. For bacterial corneal ulcers, Tsipromed is used 1 drop every 15 minutes for 6 hours, then 1 drop every 30 minutes during waking hours; on day 2 – 1 drop every hour during waking hours; from days 3 to 14 – 1 drop every 4 hours during waking hours. If epithelization has not occurred after 14 days of therapy, treatment can be continued. To prevent infection and a calm course of the postoperative period after surgical interventions, Tsipromed is prescribed 4–8 times a day for the entire period of the postoperative period, usually from 5 days to 1 month. Ciprofloxacin has an antibacterial effect at concentrations from 0.001 to 2 mg/ml. The effective time of action of Tsipromed in the conjunctiva is from 15 minutes to 2 hours, in the cornea – from 10 minutes to 6 hours, in the moisture of the anterior chamber – from 10 minutes to 4 hours [1]. The effectiveness of Tsipromed in the treatment of eye infections is associated, in particular, with its good penetration into biological fluids, due to its lipophilicity. Tsipromed penetrates into the aqueous humor and vitreous body. Average concentrations after topical use are 0.44±0.07 µg/ml in aqueous humor and 0.22±0.04 µg/ml in the vitreous. Differences between ciprofloxacin concentrations in aqueous humor and vitreous humor may be due to more barriers to penetration and a higher dilution factor, which increases due to the large volume of vitreous humor [2–4]. In the presence of an inflammatory process, the concentration of ciprofloxacin increases both in the aqueous humor and in the vitreous body [5,6]. The drug is excreted primarily through the kidneys (up to 50%). Residual concentrations of ciprofloxacin can be determined within 24 hours after instillation. Tsipromed is an effective antimicrobial agent in comparison with most locally used antibacterial agents. In a comparative study of the penetration ability of ofloxacin, ciprofloxacin and norfloxacin in patients with bacterial keratitis, the concentration of all three antibiotics in the cornea exceeded the MIC for most gram-negative bacteria, with the exception of Acinobacter spp. and P. aeruginosa, for which only the concentration of ciprofloxacin exceeded the MIC. A study showed that ciprofloxacin and ofloxacin have some advantage over norfloxacin in terms of creating sufficient concentrations in the cornea [7]. The transcorneal penetration of ciprofloxacin, ofloxacin and norfloxacin into the aqueous humor was studied in patients receiving the drug with different dosage regimens. The most effective regimen was one drop every 15 minutes for 2 hours before surgery. Additional administration of the drug the day before surgery did not lead to an increase in the level of antibiotics in the aqueous humor [15]. The most common causative agents of bacterial conjunctivitis are H. influenzae and S. pneumoniae. Ciprofloxacin, along with rifampicin and chloramphenicol, exhibits the greatest clinical effectiveness against these pathogens [8]. In the treatment of bacterial conjunctivitis and blepharitis with a 0.3% solution of ciprofloxacin and a 1% solution of rifampicin, clinical improvement was observed in more than 90% of patients, however, the number of completely cured patients by the 7th day of drug use was 53% for ciprofloxacin, and 23% for rifampicin . When comparing the effectiveness of ciprofloxacin and tobramycin in patients with blepharitis and blepharoconjunctivitis, 7 days after the start of treatment, a bacteriological study determined a decrease in the number of potentially pathogenic bacteria in 93.7% of cases (ciprofloxacin) compared to 88.9% (tobramycin) [12] . A study conducted by Adenis JP, Colin J. et al in 1995 compared the local antibacterial effect of a 0.3% solution of ciprofloxacin with placebo or a 0.3% solution of tobramycin. Ciprofloxacin provided a reduction in all isolated bacterial strains, confirming its broad antibacterial spectrum and potential effectiveness in the treatment of external eye infections [11,13]. In a comparative study of the effectiveness of ciprofloxacin, gentamicin and tobramycin, it was found that against most pathogens of eye infections, the effectiveness of ciprofloxacin in vitro is higher than that of gentamicin and tobramycin, but the effectiveness against staphylococcal strains of ciprofloxacin is equivalent to gentamicin and tobramycin [9]. The effectiveness of ciprofloxacin in the treatment of bacterial keratitis refractory to conventional therapy has also been confirmed. Successful cure was observed in 72.7% of patients who were prescribed the drug [10]. In the case of the treatment of bacterial corneal ulcers, monotherapy with a 0.3% solution of ciprofloxacin corresponds to therapy with a combination of tobramycin and cefazolin. Cure was observed in 91.5% of cases when ciprofloxacin was prescribed compared to 86.2% with standard treatment [14]. There has also been a large number of studies done on the safety of ciprofloxacin solution used to treat eye infections. The drug is well tolerated by patients. Taking into account the data from clinical studies, the drug Tsipromed, 0.3% eye drops, is an effective and safe drug and can be recommended for widespread use in ophthalmological practice.

The article was accepted for publication on May 30, 2007.

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