Gatifloxacin

ZYMAXID ® 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 these organisms were studied in fewer than 10 infections. ZYMAXID ® is a quinolone antimicrobial 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 pneumoniae

Gatifloxacin is a quinolone antimicrobial.

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.

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

Hypersensitivity. Growth of Resistant Organisms with Prolonged Use. Corneal Endothelial Cell Injury 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. 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.

The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Growth of Resistant Organisms With Prolonged Use Corneal Endothelial Cell Injury Most common adverse reactions occurring in ≥ 1 % of patients included worsening of conjunctivitis, eye irritation, dysgeusia, and eye pain. 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.

Store at 15°-25°C (59°-77°F). Protect from freezing.