Generic Name
Ofloxacin
Brand Names
Ocuflox, Ofloxacin Ophth, Olfoxacin
FDA approval date: August 01, 1993
Classification: Quinolone Antimicrobial
Form: Tablet, Solution
What is Ocuflox (Ofloxacin)?
OCUFLOX ® ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: *Efficacy for this organism was studied in fewer than 10 infections CONJUNCTIVITIS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Pseudomonas aeruginosa Staphylococcus epidermidis Serratia marcescens* Streptococcus pneumoniae Anaerobic species: Propionibacterium acnes.
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Brand Information
OCUFLOX (ofloxacin)
1DESCRIPTION
OCUFLOX® (ofloxacin ophthalmic solution) 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-7
![(±)-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.](https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ocuflox-01.jpg&setid=7aab4449-3dda-4e2c-8e40-b3244a548bf5)
Contains: Active: ofloxacin 0.3% (3 mg/mL). Preservative: benzalkonium chloride (0.005%).
Inactives: sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
OCUFLOX® solution 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.
2INDICATIONS AND USAGE
OCUFLOX® ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
*Efficacy for this organism was studied in fewer than 10 infections
3CONTRAINDICATIONS
OCUFLOX® 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).
4WARNINGS
NOT FOR INJECTION.
OCUFLOX® solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
There are rare reports of anaphylactic reaction/shock and fatal hypersensitivity reactions in patients receiving systemic quinolones, some following the first dose, 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.
5DOSAGE AND ADMINISTRATION
The recommended dosage regimen for the treatment of
6HOW SUPPLIED
OCUFLOX® (ofloxacin ophthalmic solution) 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with tan high impact polystyrene (HIPS) caps as follows:
5mL in 10mL bottle - NDC 11980-779-05
Note: Store at 15°-25°C (59°-77°F)
Rx only
Revised:06/2024
Distributed by:
© 2024 AbbVie. All rights reserved.
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7PRINCIPALDISPLAY PANEL
NDC 11980-779-05
