ZYMAXID® (gatifloxacin ophthalmic solution) 0.5%
ZYMAXID®, approved by the U.S. Food and Drug Administration in 2010, is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms; Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group*, Streptococcus oralis*, Streptococcus pneumonia (* Efficacy for this organism was studied in fewer than 10 infections).
Important Safety Information
Warnings and Precautions
ZYMAXID® solution should not be introduced directly into the anterior chamber of the eye. As with other anti-infectives, prolonged use of ZYMAXID® may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis or during the course of therapy with ZYMAXID®.
The most frequently reported adverse reactions occurring in > 1% of patients in the gatifloxacin study population (N=717) were: worsening of the conjunctivitis, eye irritation, dysgeusia, and eye pain.
Additional adverse events reported with other formulations of gatifloxacin ophthalmic solution include chemosis, conjunctival hemorrhage, dry eye, eye discharge, eyelid edema, headache, increased lacrimation, keratitis, papillary conjunctivitis, and reduced visual acuity.