Levofloxacin
Generic: LEVOFLOXACIN
Basic Information
Manufacturer
BPI LABS LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
b6d9740b-2f9d-4f1c-bc9b-4c2150b22f10
Indications & Usage
1 INDICATIONS AND USAGE Levofloxacin ophthalmic 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 Levofloxacin ophthalmic solution is a topical quinolone anti-microbial indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria: Corynebacterium species * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Viridans group streptococci* Pseudomonas aeruginosa Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections.
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Adverse Reactions
6 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 to 10% of patients.
Adverse reactions occurring in approximately 1 to 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.
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 to 10% of patients.
(6) To report SUSPECTED ADVERSE REACTIONS,contact BPI Labs LLC at (727)471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
These reactions occurred in approximately 8 to 10% of patients.
Adverse reactions occurring in approximately 1 to 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.
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 to 10% of patients.
(6) To report SUSPECTED ADVERSE REACTIONS,contact BPI Labs LLC at (727)471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.