Ofloxacin
Ofloxacin Prescribing Information
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: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae | Gram-negative bacteria: Enterobacter cloacae Haemophilus influenzae Proteus mirabilis Pseudomonas aeruginosa |
CORNEAL ULCERS: | |
Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae | Gram-negative bacteria: Pseudomonas aeruginosa Serratia marcescens Efficacy for this organism was studied in fewer than 10 infections |
Anaerobic species: Propionibacterium acnes |
The recommended dosage regimen for the treatment of
Days 1 and 2 | Instill one to two drops every two to four hours in the affected |
Days 3 through 7 | Instill one to two drops four times daily. |
Days 1 and 2 | Instill one to two drops into the affected eye every 30 minutes, while awake. Awaken at approximately four and six hours after retiring and instill one to two drops. |
Days 3 through 7 to 9 | Instill one to two drops hourly, while awake. |
Days 7 to 9 through treatment completion | Instill one to two drops, four times daily. |
Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (see Warnings).
The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/ keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing,
dryness, and eye pain. Rare reports of dizziness and nausea have been received.
Refer to Warnings for additional adverse reactions.
Specific drug interaction studies have not been conducted with ofloxacin ophthalmic solution. 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 cyclosporine concomitantly.
Ofloxacin Ophthalmic Solution USP 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use.
(±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-
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.