Ofloxacin Ophthalmic

Ofloxacin Ophthalmic

Ofloxacin Ophthalmic Recall

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Questions & Answers

Side Effects & Adverse Reactions


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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes 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:

*Efficacy for this organism was studied in fewer than 10 infections

    Gram-positive bacteria:     Gram-negative bacteria:
        Staphylococcus aureus         Enterobacter cloacae
        Staphylococcus epidermidis         Haemophilus influenzae
        Streptococcus pneumoniae         Proteus mirabilis
        Pseudomonas aeruginosa
    Gram-positive bacteria:     Gram-negative bacteria:
        Staphylococcus aureus         Pseudomonas aeruginosa
        Staphylococcus epidermidis         Serratia marcescens*
        Streptococcus pneumoniae     Anaerobic species:
        Propionibacterium acnes


There is currently no drug history available for this drug.

Other Information

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-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid.


Contains: Active: Ofloxacin 0.3% (3 mg/mL).

Preservative: benzalkonium chloride (0.005%). Inactives: Hydrochloric acid, sodium chloride and water for injection. Sodium hydroxide may be added to adjust the pH.

Ofloxacin ophthalmic solution 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.

Ofloxacin Ophthalmic Manufacturers

  • Apotex Corp.
    Ofloxacin Ophthalmic (Ofloxacin) Solution [Apotex Corp.]
  • Altaire Pharmaceuticals Inc.
    Ofloxacin Ophthalmic (Ofloxacin) Solution [Altaire Pharmaceuticals Inc.]

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