ZYMAXID

2 DOSAGE AND ADMINISTRATION Day 1: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times.

Day 2 through Day 7:

Instill one drop two to four times daily in the affected eye(s) while awake.

Day 1:

Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1.

Days 2 through 7:

Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7. ( 2 )

3 ) ] Most common adverse reactions occurring in ≥ 1 % of patients included worsening of conjunctivitis, eye irritation, dysgeusia, and eye pain. gov/medwatch. 6. 1 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 of patients with bacterial conjunctivitis treated with ZYMAXID ® (N=717), the most frequently reported adverse reactions occurring in ≥ 1 % of patients were: worsening of the conjunctivitis, eye irritation, dysgeusia, and eye pain.

Additional adverse reactions reported with other formulations of gatifloxacin ophthalmic solution in other clinical studies included chemosis, conjunctival hemorrhage, dry eye, eye discharge, eyelid edema, headache, increased lacrimation, keratitis, red eye, papillary conjunctivitis, and reduced visual acuity.

2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ZYMAXID ® or with other formulations of gatifloxacin ophthalmic solution. 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 included anaphylactic reactions and angioedema (including pharyngeal, oral or facial edema), blepharitis, dyspnea, eye pruritus, eye swelling (including corneal and conjunctival edema), hypersensitivity, including signs and symptoms of eye allergy and allergic dermatitis, nausea, pruritus (including pruritus generalized, rash, urticaria), and vision blurred.

1 Hypersensitivity Some patients receiving topical ophthalmic gatifloxacin experienced hypersensitivity reactions including anaphylactic reactions, angioedema (including pharyngeal, laryngeal, or facial edema), dyspnea, urticaria, and itching, even following a single dose.

Rare cases of Stevens-Johnson Syndrome were reported in association with topical ophthalmic gatifloxacin use. If an allergic reaction to gatifloxacin occurs, discontinue the drug [see Patient Counseling Information ( 17 )] . 2 Growth of Resistant Organisms with Prolonged Use Prolonged use of ZYMAXID ® may result in overgrowth of nonsusceptible organisms, including fungi.

If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, examine the patient with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluorescein staining.

5. 3 Corneal Endothelial Cell Injury ZYMAXID ® is for topical ophthalmic use. ZYMAXID ® may cause corneal endothelial cell injury if introduced directly into the anterior chamber of the eye.

1 )] . ZYMAXID ® is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication. ( 4 )