COMPOSITION:
Each 1 mL contains:
15.36mg of levofloxacin hemihydrate (equivalent to 15 mg levofloxacin).
INDICATIONS:
Floxamina Fort solution is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria:
Gram-positive Bacteria:
Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumonia, Viridans group streptococci*
Gram-negative Bacteria:
Pseudomonas aeruginosa, Serratia marcescens*
*Efficacy for this organism was studied in fewer than 10 infections
CONTRAINDICATIONS:
Floxamina Fort is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones,
or to any of the components in this medication.
WARNINGS:
NOT FOR INJECTION.
Floxamina Fort should not be injected subconjunctivally, 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.
PRECAUTIONS:
General:
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi.
If superinfection occurs, discontinue use and institute alternative therapy.
Patients should be advised not to wear contact lenses if they have signs and symptoms of corneal ulcer.
Information for Patients:
Avoid contaminating the applicator tip with material from the eye, fingers or other source.
Systemic quinolones have been associated with hypersensitivity reactions, even following a single dose.
Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.
Pregnancy:
Floxamina Fort should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
Caution should be exercised when Floxamina Fort is administered to a nursing mother.
Pediatric Use:
Safety and effectiveness in children below the age of six years have not been established
Geriatric Use:
No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
ADVERSE REACTIONS:
The most frequently reported adverse reactions in the overall study population were headache and a taste disturbance following instillation.
These reactions occurred in approximately 8-10% of patients.
Adverse reactions occurring in approximately 1-2% of patients included decreased/blurred vision, diarrhea, dyspepsia, fever, infection,
instillation site irritation/discomfort, ocular infection, nausea, ocular pain/discomfort, and throat irritation.
Other reported ocular reactions occurring in less than 1% of patients included chemosis, corneal erosion, diplopia, floaters, hyperemia, lid edema, and lid erythema.
DOSAGE& ADMINISTRATON:
Days 1 Through 3:
Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring.
Day 4 Through Treatment Completion:
Instill one to two drops in the affected eye(s) very 1 to 4 hours while awake.