NOT FOR INJECTION.
Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.
There is currently no manufacturer warning information available for this drug.
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
CONJUNCTIVITIS:
| Gram-positive bacteria: | Gram-negative bacteria: |
| Staphylococcus aureus | Enterobacter cloacae |
| Staphylococcus epidermidis | Haemophilus influenzae |
| Streptococcus pneumoniae | Proteus mirabilis |
| Pseudomonas aeruginosa |
CORNEAL ULCERS:
|
*Efficacy for this organism was studied in fewer than 10 infections |
||
| Gram-positive bacteria: | Gram-negative bacteria: | Anaerobic species: |
| Staphylococcus aureus | Pseudomonas aeruginosa | Propionibacterium acnes |
| Staphylococcus epidermidis | Serratia marcescens* | |
| Streptococcus pneumoniae | ||
Ofloxacin Ophthalmic Solution USP, 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use.
Chemical Name: (±)-9-Fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid.
Contains: Active: ofloxacin 0.3% (3 mg/mL);
Inactives: sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Preservative: benzalkonium chloride (0.005%);
Ofloxacin Ophthalmic Solution USP, 0.3% is unbuffered and formulated with a pH of 6.4 (range – 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.
