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Zylet (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension)



                                                  Prescribing Information

ZYLET treats inflammatory eye conditions that involve bacterial infection or a risk of
bacterial infection, including common conditions like blepharitis, nonspecific
conjunctivitis, and contact lens-induced acute red eye.1



INDICATION

ZYLET (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension) is used to treat certain inflammatory eye conditions that have either a bacterial infection or a risk of bacterial infection. ZYLET contains two types of medicines. One is an anti-inflammatory and the other is an anti-bacterial medicine.

IMPORTANT SAFETY INFORMATION

  • Do not use ZYLET if you have eye infections caused by: most types of viruses; bacteria known as mycobacteria; or fungus.
  • ZYLET contains a medicine known as a corticosteroid. Using corticosteroids for a long period of time may result in glaucoma and impaired vision. If you use ZYLET for 10 days or longer, your doctor may monitor pressure in your eye.
  • Use of corticosteroids may result in cataract formation.
  • Use of steroids (corticosteroids) after cataract surgery may delay healing and increase bleb formation (a type of lesion on the eye).
  • Use of corticosteroids may increase the chance, or the severity, of an infection in your eye, or it may hide an eye infection. If your eye symptoms do not improve after 2 days of taking ZYLET, contact your doctor for an examination.
  • The most common adverse reactions were eye redness, superficial punctate keratitis (a specific type of eye surface irritation), increased pressure in the eye, and burning and stinging when putting ZYLET drops in the eye.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.

Please click here for full Prescribing Information for ZYLET.


References

ZYL.0033.USA.17