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Ofloxacin Ophthalmic Solution

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Ofloxacin Ophthalmic Solution

INDICATIONS

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:
Gram-positive bacteria: Gram-negative bacteria: Anaerobic species:
Staphylococcus aureus Pseudomonas aeruginosa Propionibacterium acnes
Staphylococcus epidermidis Serratia marcescens*  
Streptococcus pneumoniae  
*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 is supplied sterile in plastic dropper bottles of the following sizes:

5mL-NDC 17478-713-10
10mL-NDC 17478-713-11

Storage

Store at 20° to 25°C (68° to 77T). [See USP Controlled Room Temperature].

Akorn Inc. Buffalo Grove, IL 60089. FDA Rev date: 5/14/2004

Last reviewed on RxList: 1/21/2009
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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