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.