ROZEX GEL

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METRONIDAZOLE

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

METRONIDAZOLE

Unit dalam pakej:

15gm mcg/mL; 30gm mcg/mL; 5gm mcg/mL

Dikeluarkan oleh:

LABS GALDERMA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ROZEX
® GEL
Metronidazole 0.75%
1
WHAT IS IN THIS LEAFLET
1.
What Rozex Gel is used for
2.
How Rozex Gel works
3.
Before you use Rozex Gel
4.
How to use Rozex Gel
5.
While you are using it
6.
Side Effects
7.
Storage
and
disposal
of
Rozex Gel
8.
Product Description
9.
Manufacturer
and
Product
Registration
Holder
10.
Date of revision
WHAT ROZEX GEL IS USED FOR
Rozex
Gel
is
used
as
topical
application
to
treat
pimples,
_pustules_
(spots) and redness that
develops with
_rosacea_
condition.
HOW ROZEX GEL WORKS
Rozex
Gel
contains
active
ingredient
_metronidazole_
which
acts
against
harmful
microorganisms
to
help
control
infection and inflammation in the
skin due to
_rosacea._
BEFORE YOU USE ROZEX GEL
-
_When you must not use it _
Rozex Gel must not be used in
individuals
with
a
history
of
hypersensitivity to
_metronidazole_
,
parabens, or other ingredients of
the formulation.
-
_Before you start to use it _
Rozex Gel has been reported to
cause
tearing
of
the
eyes.
Therefore, contact
with the eyes
should
be
avoided.
If
local
irritations occur, patient should be
directed
to
use
less
frequently,
discontinue
use
temporarily
or
discontinue
use
until
further
instruction.
-
_Taking other medicines _
Rozex
Gel
is
expected
to
have
minimal
interactions
with
other
medications. Individuals who
are
receiving
anticoagulant
treatment
should
inform
their
doctor,
as
absorption
of
metronidazole
into
the bloodstream may increase the
anticoagulant
(blood
thinning)
effect of such medication.
HOW TO USE ROZEX GEL
-
_How much to use _
Apply and rub in a thin film of
Rozex
Gel
twice
daily,
morning
and evening, to the entire affected
areas after washing.
-
_When to use it _
Apply
twice
daily,
morning
and
evening. Cosmetics may be used
after application of Rozex Gel.
_How long to use it _
Improvement
should
be
noticed
within three weeks. Your doctor
will decide how long you need to
use
Rozex
Gel
to
keep
your
_rosacea_
under control.
_If you forget to use it _
Although this gel works best if yo

Ciri produk

R O Z E X
®
m e t r o n i
d a z o l
e
T O P I
C A L
G E L
NOTICE RECTO 180x315
PLAN n° MT.09.DRA.0352.R02.2
COMPOSITION
ROZEX Gel contains metronidazole 0.75% as the active ingredient in a
single phase, colourless to pale yellow, viscous and homogenous
gel containing purified water, methylparaben, propylparaben, propylene
glycol, carbomer 940, disodium edetate and sodium hydroxide.
PHARMACEUTICAL FORM
ROZEX Gel is for cutaneous use only.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS: Metronidazole has an antibacterial and antiprotozoal
effect against a large number of pathogenic micro-
organisms. The mechanism of action of metronidazole in rosacea is not
known but pharmacological data available suggest that the
activity is based on an antibacterial and / or anti-inflammatory
action.
PHARMACOKINETICS: Following a single, topical 7.5mg application of
ROZEX Gel to the face of ten rosacea patients (aged 36 to 70
years), the maximum metronidazole serum concentration (C
max
) ranged from below detectable limits (n =3) to 66 ng/mL, with a
mean in the seven patients with quantifiable serum concentrations of
40.6 ng/mL. The mean C
max
following 30 mg oral dose of a 5
mg/mL metronidazole solution administered in the same patients was 850
ng/mL. When corrected for the dose difference between
formulations, the estimated C
max
for the oral solution is 212 ng/mL. The difference in C
max
between the two formulations was
significant (p < 0.01). The time of the maximum serum concentration (T
max
) was also found to be significantly (p < 0.01) different
between the two formulations. The median Tmax was 5.98 hours with the
topical gel as compared to 0.97 hours with the oral
solution. An accurate estimation of the area under the curve (AUC)
following the topical 0.75% gel was not possible because of
undetectable serum concentrations at the majority time points. The
mean (%CV) AUC following the oral solution was 7476.1 (35.8%)
ng.hr/mL. Serum metronidazole and the hydroxymethyl metabolite
(2-hydroxymethylmetronidazole) were below the