DAFLOX Eye drops

for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

AEROBIC GRAM-POSITIVE MICROORGANISMS

Corynebacterium species*

Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus pneumoniae

Streptococcus (Groups C/F)

Streptococcus (Group G)

Viridans group streptococci

AEROBIC GRAM-NEGATIVE MICROORGANISMS

Acinetobacter lwoffii*

Haemophilus influenzae

Serratia marcescens*

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

Dosage

Days 1,2: Instill 1-2 drops in the affected eye(s) every 2 hours while awake, up to 8 times/day.

Days 3-7: Instill 1-2 drops in the affected eye(s) every 4 hours while awake, up to 4 times/day.

in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components of this medication.

The most frequently reported adverse events in the overall study populations were transient decreased vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia. These events occurred in approximately 1-3% of patients. Other reported reactions occurring in less than 1% of patients included allergic reactions, lid edema, ocular dryness and ocular itching

Specific drug interaction studies have not been conducted with this medicine. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.

Pregnancy

There are no adequate and well-controlled studies in pregnant woman. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers

Levofloxacin has not been measured in human milk. Based upon data from ofloxacin, it can be presumed that levofloxacin is excreted in human milk. Caution should be exercised when Levofloxacin Ophthalmic Solution is administered to a nursing mother.

NOT FOR INJECTION. Daflox should not be injected subconjunctially, nor should it be introduced directly into the anterior chamber of the eye.

In patients receiving systemic quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. 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 levofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.