Ofloxacin Ophthalmic
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Questions & Answers
Side Effects & Adverse Reactions
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.
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.
Uses
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 |
|
| 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 | |
History
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.
(±)-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.
Sources
Ofloxacin Ophthalmic Manufacturers
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Apotex Corp.
![Ofloxacin Ophthalmic (Ofloxacin) Solution [Apotex Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ofloxacin Ophthalmic | Apotex Corp.
The recommended dosage regimen for the treatment of bacterial conjunctivitis is:
Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s). Days 3 through 7 Instill one to two drops four times daily. The recommended dosage regimen for the treatment of bacterial corneal ulcer is: 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. -
Altaire Pharmaceuticals Inc.
Ofloxacin Ophthalmic | Altaire Pharmaceuticals Inc.
The recommended dosage regimen for the treatment of bacterial conjunctivitis is:
Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s). Days 3 through 7 Instill one to two drops four times daily.The recommended dosage regimen for the treatment of bacterial corneal ulcer is:
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 (Ofloxacin) Solution [Altaire Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fe564e33-8f5d-4b57-87a9-7afae02eaf97&name=ofloxacin-ophthalmic-solution-0_3-02.jpg)
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