Ofloxacin ophthalmic solution is used in the treatment of keratitis and conjunctivitis caused by susceptible bacteria. Prior to initiation of topical ophthalmic ofloxacin therapy, appropriate specimens generally should be collected for identification of the causative organism and in vitro susceptibility tests. Ofloxacin may be started pending results of susceptibility tests but should be discontinued and other more appropriate therapy instituted if the causative organism is shown to be resistant to ofloxacin.
Ofloxacin otic solution is instilled into the ear canal for the treatment of otitis externa, chronic suppurative otitis media, or acute otitis media caused by susceptible bacteria.
Ofloxacin ophthalmic solution is used in the treatment of keratitis (corneal ulcers) caused by susceptible Pseudomonas aeruginosa, Propionibacterium acnes, Serratia marcescens, Staphylococcus aureus, S. epidermidis, or Streptococcus pneumoniae; the drug is designated an orphan drug by the US Food and Drug Administration (FDA) for this use. Results of comparative studies in patients receiving a fluoroquinolone ophthalmic solution (e.g., ciprofloxacin, ofloxacin) for bacterial keratitis suggests that such therapy produces results comparable to those observed with more complex treatment regimens (e.g., a topical ''fortified'' aminoglycoside used in conjunction with a topical cephalosporin).
Results from a randomized, double-blind, multicenter clinical study in patients with bacterial keratitis indicate that ofloxacin ophthalmic solution is as effective as a topical regimen consisting of tobramycin 1.5% solution and cefazolin 10% solution (prepared extemporaneously; not commercially available in the US). In this study, treatment with ofloxacin 0.3% ophthalmic solution in the recommended dosage resulted in clinical cure (i.e., complete reepithelization and no progression of the infiltrate on 2 consecutive visits) in 82% of patients compared with 80% of those receiving therapy with topical tobramycin 1.5% used concomitantly with topical cefazolin 10%. While nonprogression of infiltrate usually occurred about 3 days after initiating therapy with either regimen, time to clinical cure occurred in about 11 or 10 days in patients receiving topical ofloxacin or concomitant therapy with topical tobramycin and topical cefazolin, respectively. In this study, success of ofloxacin therapy did not depend on the patient's age, initial size of the epithelial defect, depth of stromal infiltrate, or presence of anterior chamber inflammation.
Ofloxacin ophthalmic solution is used for the treatment of conjunctivitis caused by susceptible Enterobacter cloacae, Haemophilus influenzae, Proteus mirabilis, Ps. aeruginosa, S. aureus, S. epidermidis, or S. pneumoniae.
Although most cases of acute bacterial conjunctivitis improve without anti-infective therapy, topical application of anti-infectives may shorten the infectious process. In addition, topical application of anti-infectives may reduce recurrence rate and morbidity associated with bacterial conjunctivitis.
Results from several controlled studies indicate that ofloxacin 0.3% ophthalmic solution is more effective than placebo (vehicle) and as effective as chloramphenicol 0.5%, gentamicin 0.3%, or tobramycin 0.3% ophthalmic solution in the treatment of acute bacterial conjunctivitis caused by various gram-positive and/or -negative pathogens. In these studies, which generally included patients with acute conjunctivitis as well as some with blepharoconjunctivitis or blepharitis, efficacy was established in terms of reduction or eradication of bacterial conjunctival pathogens and improvement in ocular manifestations (e.g., discharge, chemosis, hyperemia, lid edema/ erythema, burning/pain, foreign body sensation, corneal edema). Topical application of ofloxacin 0.3% ophthalmic solution to the eye for 7-10 days was effective in reducing or eradicating all conjunctival pathogens in 78-85% of patients with bacterial conjunctivitis, blepharoconjunctivitis, or blepharitis and produced clinical improvement in virtually all patients.
Ofloxacin otic solution is instilled into the ear canal for the treatment of otitis externa caused by susceptible Escherichia coli, S. aureus or P. aeruginosa. Results of comparative studies in adults and children with otitis externa indicate that ofloxacin otic solution is as effective as combined neomycin, polymyxin B, and hydrocortisone (e.g., Cortisporin) otic solution as evaluated by clinical and microbiologic response.
Although acute bacterial otitis externa localized in the external auditory canal may be effectively treated using topical anti-infectives (e.g., ciprofloxacin otic suspension, ofloxacin otic solution), malignant otitis externa is an invasive, potentially life-threatening infection, especially in immunocompromised patients such as those with diabetes mellitus or human immunodeficiency virus (HIV) infection, and requires prompt diagnosis and long-term treatment with parenteral anti-infectives (e.g., ceftazidime and/or ciprofloxacin).
Chronic Suppurative Otitis Media
Ofloxacin otic solution is instilled into the ear canal in patients with perforated tympanic membranes for the treatment of chronic suppurative otitis media (CSOM) caused by susceptible S. aureus, P. mirabilis, or P aeruginosa. Because commercially available ofloxacin otic solution is sterile, unlike ciprofloxacin and hydrocortisone otic suspension (which is nonsterile), the ofloxacin otic solution can be used in the treatment of otic infections even when the tympanic membrane is perforated.
In one open label study in patients with chronic suppurative otitis media and a chronically perforated tympanic membrane in the infected ear(s), treatment with ofloxacin otic solution resulted in complete resolution of otorrhea 7-10 days after completion of therapy in 91% of patients and microbiologic response in 100% of evaluable patients.
Topical anti-infectives (e.g., ciprofloxacin otic suspension, ofloxacin otic solution, gentamicin) used in conjunction with daily aural toilet can be effective for the treatment of uncomplicated CSOM; more severe or persistent infections require treatment with a parenteral anti-infective (e.g., ceftazidime, clindamycin, ciprofloxacin, gentamicin, ticarcillin, ticarcillin disodium and clavulanate potassium).
Acute Otitis Media
Ofloxacin otic solution is instilled into the ear canal in patients with tympanostomy tubes for the treatment of acute otitis media caused by susceptible S. aureus, S. pneumoniae, H. influenzae, Moraxella catarrhalis, or P. aeruginosa.
For systemic uses of ofloxacin,