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:

CONJUNCTIVITIS

Gram-positive bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae

Gram-negative bacteria:
Enterobacter cloacae
Haemophilus influenzae
Proteus mirabilis
Pseudomonas aeruginosa

CORNEAL ULCERS

Gram-positive bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae

Gram-negative bacteria:
Pseudomonas aeruginosa
Serratia marcescens*

Anaerobic species:
Propionibacterium acnes

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

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 USP, 0.3% is supplied sterile in plastic DROP-TAINER® of the following sizes:

5 mL NDC 61314-012-05

10 mL NDC 61314-012-10

STORAGE: Store at 15°-25°C (59°-77°F).

Rx Only

Dist. by:
FALCON Pharmaceuticals, Ltd .
Fort Worth, Texas 76134 USA

Mfd. by:
ALCON Manufacturing, Ltd.
Fort Worth, Texas 76134 USA

Printed in USA

November 2003

340324-1103