INTRODUCTION
Gatifloxacin ophthalmic solution 0.3% was administered to one eye of 6 healthy male subjects each in an escalated dosing
regimen starting with a single 2 drop dose, then 2 drops 4 times daily for 7 days and finally 2 drops 8 times daily for 3 days At all time points, serum
gatifloxacin levels were below the lower limit of quantification (5 ng/ml) in all subjects.

INDICATIONS
Gatieye solution is indicated for the treatment of external bacterial infections of the eye

DIRECTIONS
The recommended dosage regimen for the treatment of bacterial conjunctivities is: Days 1 and 2: Instill one drop
every two hours in the affected eye (s) while awake, up to 8 times daily. Days 3 to 7: Instill one drop up to four times daily while awake

WARNINGS
NOT FOR INJECTION
Gatieye solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. in patients receiving
systemic quinolones, including gatifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose,
have been reported. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal,
pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. if an allergic reaction to gatifloxacin occurs, discontinue the drug.
Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as
clinically indicated.

SIDE EFFECTS
There were no teratogenic effects observed in rats or rabbits following oral gatifloxacin
doses up to 50 mg/kg/day (approximately 1000- fold higher than the maximum recommended ophthalmic dose). However, skeletal/ craniofacial
malformations or delayed ossification, atrial enlargement, and reduced fetal weight were observed in fetuses from rats given > 150mg/kg/day
(approximately 3000-fold higher than the maximum recommended ophthalmic dose). In a perinatal/postnatal study, increased late post- implantation
loss and neonatal/perinatal mortalities were observed at 200mg/kg/day (approximately 4500 times the maximum recommended ophthalmic dose).
Because there are no adequate and well controlled studies in pregnant women, Gatieye solution should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus

PACKING
Eye Drops is available in 5ml plastic dropper vial.

Storage :
Store in cool & dry place, Protect from light. Use the solution within one month after opening the container. For external use only.

Medicine :
Keep out of reach of children.
Use the solution within one month after opening the container.
For external use only.