OFLOXACIN- ofloxacin_solution/ drops

Pharmacokinetics: Tear ofloxacin concentrations ranged from 5. 7 to 31 mcg/g during the 40 minute period following the last dose on day 11. Mean tear concentration measured four hours after topical ophthalmic dosing was 9. Corneal tissue concentrations of 4. 4 mcg/mL were observed four hours after beginning topical ocular application of two drops of ofloxacin ophthalmic solution every 30 minutes. Ofloxacin was excreted in the urine primarily unmodified. Microbiology: in vitro Cross-resistance has been observed between ofloxacin and other fluoroquinolones. There is generally no cross-resistance between ofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides. Ofloxacin has been shown to be active against most strains of the following organisms both in vitro Error! Hyperlink reference not valid. *Efficacy for this organism was studied in fewer than 10 infections AEROBES, GRAM-POSITIVE: AEROBES, GRAM-NEGATIVE: ANAEROBIC SPECIES: Staphylococcus aureus Enterobacter cloacae Propionibacterium acnes Staphylococcus epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens* The safety and effectiveness of ofloxacin ophthalmic solution in treating ophthalmologic infections due to the following organisms have not been established in adequate and well-controlled clinical trials. Ofloxacin ophthalmic solution has been shown to be active in vitro AEROBES, GRAM-POSITIVE: AEROBES, GRAM-NEGATIVE: OTHER: Enterococcus faecalis Acinetobacter calcoaceticus var. anitratus Chlamydia trachomatis Listeria monocytogenes Acinetobacter calcoaceticus var. Iwoffii Staphylococcus capitis Citrobacter diversus Staphylococcus hominus Citrobacter freundii Staphylococcus simulans Enterobacter aerogenes Streptococcus pyogenes Enterobacter agglomerans Escherichia coli Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae Moraxella (Branhamella) catarrhalis Moraxella lacunata Morganella morganii Neisseria gonorrhoeae Pseudomonas acidovorans Pseudomonas fluorescens Shigella sonnei Conjunctivitis: Corneal ulcers:.

INDICATIONS AND USAGE
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

The recommended dosage regimen for the treatment of bacterial conjunctivitis 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 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.

Ophthalmic use: Refer to for additional adverse reactions.

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 ).

Clinical Studies:
Conjunctivitis: Corneal ulcers:.
WARNINGS
NOT FOR INJECTION. Ofloxacin ophthalmic 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.

Preferred Pharmaceuticals Inc.

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