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Ofloxacin Ophthalmic (Ofloxacin Ophthalmic) - Indications and Dosage

 
 



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:

*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

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Ofloxacin ophthalmic solution 0.3% is supplied sterile in plastic dropper bottles with tan caps in the following sizes:

5mL - NDC 60505-0560-0 

10mL - NDC 60505-0560-1

Store at 25°C (77°F); excursions permitted 15 - 30°C (59 - 86°F).

Manufactured by:                                Manufactured for:

Apotex Inc.                                         Apotex Corp.

Toronto, Ontario                                  Weston, FL 33326

Canada M9L 1T9

288421                                               August 2011

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