ZYMAR 0.3% EYE DROPS

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

GATIFLOXACIN

제공처:

Allergan Malaysia Sdn Bhd

INN (국제 이름):

GATIFLOXACIN

패키지 단위:

5ml mL

Manufactured by:

Allergan Sales, LLC

환자 정보 전단

ZYMAR™
gatifloxacin (0.3%) Ophthalmic Solution
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
ZYMAR™
is used for
2.
How
ZYMAR™
works
3.
Before you use
ZYMAR™
4.
How to use
ZYMAR™
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
ZYMAR™
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
1. WHAT ZYMAR™
IS USED FOR
ZYMAR™
is used to treat the signs and
symptoms
of
bacterial
eye
surface
inflammation in patients 1 year of age or
older.
2. HOW ZYMAR™
WORKS
ZYMAR™
is
an
antibiotic
eye
drop
used
to
treat
bacterial
eye
infections.
ZYMAR™
kills many kinds of bacteria
that can cause infections of the eye and is
ineffective against viruses.
3. BEFORE YOU USE ZYMAR™
-
_When you must not use it _
_ _
Do not use
ZYMAR™
:
-
If you are allergic (hypersensitive to
gatifloxacin,
or
any
of
the
other
ingredients
of
ZYMAR™
.
(for
a
full list of ingredients, see section 8
“PRODUCT DESCRIPTION”).
-
If
you
have
ever
had
an
allergic
reaction to gatifloxacin Tablets or
I.V., or any medicine in the group of
antibiotics known as “quinolones”,
such as ciprofloxacin, levofloxacin,
moxifloxacin,
ofloxacin,
or
norfloxacin.
-
_Pregnancy and lactation _
Ask
your
doctor
or
pharmacist
for
advice before using
ZYMAR™
if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Ask
your
doctor
or
pharmacist
for
advice before using
ZYMAR™
if you
are breast-feeding.
-
_Children _
ZYMAR™
is not recommended for
children under 1 year of age.
-
_Before you start use it _
Take special care with
ZYMAR™
.
If
you
have
allergies
to
other
medications, discuss with your doctor
before taking
ZYMAR™
.
-
_Taking other medicines _
Discuss with your doctor if you are
taking
other
eye
drops
other
than
ZYMAR™
.
Tell your doctor if you are taking any
other
medicines,
including
any
that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
4. HOW TO USE ZYMAR™
-
_How much to use _
The recom

제품 특성 요약

ZYMAR
™
(GATIFLOXACIN OPHTHALMIC SOLUTION) 0.3%
STERILE
DESCRIPTION
ZYMAR™ (gatifloxacin ophthalmic solution) 0.3% is a sterile
ophthalmic solution. It is an 8-methoxy fluoroquinolone anti-
infective for topical ophthalmic use.
CHEMICAL NAME:
(±)-1-cyclopropyl-6-fluoro-1,4-dihydro-8-
methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-
quinolinecarboxylic acid sesquihydrate
CONTAINS: ACTIVE:
gatifloxacin 0.3% (3 mg/mL).
PRESERVATIVE:
benzalkonium chloride 0.005%.
INACTIVES:
edetate disodium;
purified water and sodium chloride. May contain
hydrochloric acid and/or sodium hydroxide to adjust pH to
approximately 6.
ZYMAR™ is a sterile, clear, pale yellow colored isotonic
unbuffered solution. It has an osmolality of 260-330 mOsm/kg.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS:
Gatifloxacin ophthalmic solution 0.3% or 0.5% was administered to one
eye of 6 healthy male
subjects each in an escalated dosing regimen starting with a single 2
drop dose, then 2 drops 4 times daily for 7 days
and finally 2 drops 8 times daily for 3 days. At all time points,
serum gatifloxacin levels were below the lower limit of
quantification (5 ng/mL) in all subjects.
MICROBIOLOGY:
Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl
substituent at C7. The
antibacterial action of gatifloxacin results from inhibition of DNA
gyrase and topoisomerase IV. DNA gyrase is an
essential enzyme that is involved in the replication, transcription
and repair of bacterial DNA. Topoisomerase IV is
an enzyme known to play a key role in the partitioning of the
chromosomal DNA during bacterial cell division.
The mechanism of action of fluoroquinolones including gatifloxacin is
different from that of aminoglycoside,
macrolide, and tetracycline antibiotics. Therefore, gatifloxacin may
be active against pathogens that are resistant to
these antibiotics and these antibiotics may be active against
pathogens that are resistant to gatifloxacin. There is no
cross-resistance between gatifloxacin and the aforementioned classes
of antibiotics. Cross resistan