Ocuflox

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Ofloxacin

Available from:

Allergan Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

OCUFLOX® OFLOXACIN EYE DROPS – CMI  
VERSION 2.0    
PAGE 1 OF 4 
CONSUMER MEDICINE INFORMATION 

OCUFLOX
®
 EYE DROPS 
(ofloxacin 3 mg/mL) 

_The information in this leaflet is ONLY a summary and is not a
complete statement about OCUFLOX_
_®_
_  eye _
_drops. Your doctor has more detailed information relating to you,
your medical history and the product and _
_should be consulted so that you will be informed about all aspects
of OCUFLOX_
_®_
_  eye drops as it relates to you. _

PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING OCUFLOX
®
 EYE DROPS AND KEEP THIS LEAFLET HANDY 
WHILE YOU ARE ON THE MEDICATION.  IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 

All medicines have benefits and risks.  Your doctor has weighed the
risks of you using OCUFLOX
®

eye drops against the benefits they expect it will have for you. 

1. PRODUCT DESCRIPTION 

WHAT ARE OCUFLOX
®
 EYE DROPS? 
These eye drops contain the drug ofloxacin and are used to treat
certain eye infections. 

WHAT IS IN OCUFLOX
®
 EYE DROPS? 
Each bottle contains ofloxacin, which is an antibiotic, as the active
ingredient.  Other ingredients 
are benzalkonium chloride 0.05 mg/mL, sodium chloride 9 mg/mL and
purified water. 

WHAT DO THEY LOOK LIKE? 
The eye drops are in a 5 mL sterile plastic bottle. 

2. WHAT OCUFLOX
®
  EYE DROPS ARE USED FOR 

HOW OCUFLOX
®
 EYE DROPS WORK 
OCUFLOX
®
 eye drops act by killing a wide range of bacteria that cause
certain eye infections such 
as conjunctivitis (inflamed eyes) and corneal ulcers (infection on the
surface of the eye). 

AVAILABILITY 
OCUFLOX
®
 eye drops are available only on prescription at pharmacies.  This
product has been 
approved in Australia for the use listed above.  However, your doctor
may prescribe this medicine 
for another use.  If you want more information, ask your doctor. 

CONTENTS  
This leaflet answers some commo

Summary of Product characteristics

OCUFLOX
®
 Product Information Version 2.0                        

                                   Page 1 of 5

OCUFLOX
®

Ofloxacin 3 mg/mL eye drops. 

NAME OF THE DRUG 
The active constituent of OCUFLOX
®
 eye drops is ofloxacin. 

_(STRUCTURE OF OFLOXACIN) _

CAS Registry No. J01MA01 

DESCRIPTION 
Ofloxacin is a white to yellow crystalline powder which is soluble in
glacial acetic acid, 
sparingly soluble in chloroform and slightly soluble in water,
methanol, ethanol or acetone.  
Its melting point is 260
° - 270°C with decomposition.  

CHEMICAL
NAME:  (±)-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. 

OCUFLOX
®
 eye drops contain 3 mg/mL ofloxacin and are formulated as an
isotonic solution 
using 9 mg/mL sodium chloride preserved with 0.05 mg/mL benzalkonium
chloride.  The pH 
of OCUFLOX
®
 eye drops range from 6.0 - 7.0. 

PHARMACOLOGY 
Ofloxacin is a third generation fluorinated 4-quinolone having broad
spectrum _in vitro_ 
bactericidal activity against certain aerobic gram-positive,
gram-negative and some 
anaerobic bacteria.  

Ofloxacin appears to have more than one mechanism contributing to its
bactericidal action.  
The primary mechanism of action is believed to be the inhibition of
bacterial DNA gyrase, the 
enzyme responsible for inserting negative supercoils into bacterial
DNA.  Apparently, this 
enzyme inhibition leads to bacterial death through a complex process
in which DNA 
synthesis is arrested and regulation of normal gene expression is
disrupted.  Ofloxacin, 
unlike most of the other quinolones, possesses an additional
bactericidal

mechanism which 
is not dependent on protein or RNA synthesis.  It is bactericidal in
both the replicating and 
nonreplicating stages of bacterial growth.  

Ofloxacin, _in vitro_ maintains an inhibitor