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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
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製品の特徴
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
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