Gatifloxacin Ophthalmic Solution

ZYMAXID® (gatifloxacin ophthalmic solution) 0.5% solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Aerobic Gram-Positive Bacteria

Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mitis group*
Streptococcus oralis*
Streptococcus pneumoniae

Aerobic Gram-Negative Bacteria

Haemophilus influenzae

*Efficacy for this organism was studied in fewer than 10 infections.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

The following serious adverse reactions are described elsewhere in the labeling:

• Hypersensitivity [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
• Growth of Resistant Organisms With Prolonged Use [see WARNINGS AND PRECAUTIONS]
• Corneal Endothelial Cell Injury [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In clinical studies with ZYMAR®, the most frequently reported adverse reactions in the overall study population were: conjunctival irritation, increased lacrimation, keratitis, and papillary conjunctivitis. These reactions occurred in approximately 5-10% of patients. Other reported reactions occurring in 1-4% of patients were chemosis, conjunctival hemorrhage, dry eye, eye discharge, eye pain, eyelid edema, headache, red eye, reduced visual acuity and taste disturbance.

An additional adverse reaction reported with gatifloxacin ophthalmic solution in other clinical studies includes worsening of the conjunctivitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of gatifloxacin ophthalmic solution 0.3%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: anaphylactic reactions and angioedema (including pharyngeal, oral or facial edema), blepharitis, dyspnea, eye pruritus, eye swelling (including corneal and conjunctival edema), hypersensitivity, nausea, pruritus (including pruritus generalized), rash, urticaria, vision blurred.

Read the entire FDA prescribing information for Zymar (Gatifloxacin Ophthalmic Solution)