Gatifloxacin Drug Information

Gatifloxacin ophthalmic solution 0.5 % 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. Gatifloxacin ophthalmic solution 0.5 % 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

• 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.

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 gatifloxacin ophthalmic solution 0.5% (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.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of gatifloxacin ophthalmic solution 0.5 %. 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.

Pregnancy Risk Summary There are no available data on the use of gatifloxacin ophthalmic solution 0.5% in pregnant women to inform a drug-associated risk. Administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. Administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses.

Data Animal Data Oral administration of gatifloxacin to pregnant rats throughout organogenesis produced teratogenic effects in rat fetuses, including skeletal/craniofacial malformations, delayed ossification, atrial enlargement, and reduced fetal weight, at doses greater than or equal to 150 mg/kg/day (approximately 600-fold higher than the maximum recommended human ophthalmic dose for gatifloxacin of 0.04 mg/kg/day, on a mg/m 2 basis). No teratogenic effects were observed in rat or rabbit fetuses at doses of gatifloxacin up to 50 mg/kg/day (approximately 200-and 400-fold higher than the MRHOD, respectively, on a mg/m 2 basis). In a perinatal/postnatal study in rats, oral administration of gatifloxacin during late gestation through lactation produced an increase in late gestation fetal loss and neonatal/perinatal mortality at 200 mg/kg/day (approximately 800-fold higher than the MRHOD on a mg/m 2 basis).

Pediatric Use The safety and effectiveness of gatifloxacin ophthalmic solution 0.5% in infants below one year of age have not been established. Gatifloxacin ophthalmic solution 0.5% has been demonstrated in clinical trials to be safe and effective for the treatment of bacterial conjunctivitis in pediatric patients one year or older.

Gatifloxacin ophthalmic solution 0.5 % is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication. Gatifloxacin ophthalmic solution 0.5 % is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication.