ROZEX GEL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metronidazole, Quantity: 7.5 mg/g

Available from:

Galderma Australia Pty Ltd

INN (International Name):

Metronidazole

Pharmaceutical form:

Gel

Composition:

Excipient Ingredients: carbomer 940; disodium edetate; methyl hydroxybenzoate; propyl hydroxybenzoate; propylene glycol; sodium hydroxide; purified water

Administration route:

Topical

Units in package:

15g, 50g, 5g, 30g, 2g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of inflammatory papules, pustules and erythema of rosacea.

Product summary:

Visual Identification: Single phase colourless to pale yellow viscous and homogeneous gel with no foreign matter.; Container Type: Tube; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-09

Patient Information leaflet

ROZEX
®
GEL
_ METRONIDAZOLE 0.75 % _
_ _
CONSUMER MEDICINE INFORMATION
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ROZEX GEL. Please
read this leaflet
carefully before you start using the ROZEX GEL. It does not contain
all the information
available on this medicine. It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of using ROZEX
GEL against the benefits it might have for you. If you have concerns
about using this
medicine ask your doctor or pharmacist.
Keep this leaflet with your tube. You may wish to read it again later.
WHAT ROZEX GEL IS USED FOR
ROZEX GEL is used for the treatment of inflammatory papules and
pustules of rosacea. Skin
affected by rosacea has one or more of the following features: a
redness that looks like a
blush; pimples; small knobbly lumps on the nose and/or thin red lines
due to enlarged blood
vessels.
The active ingredient in ROZEX GEL is metronidazole, which belongs to
the class of
medicines known as antiprotozoals and antibacterials.
It is not clear how ROZEX GEL works however it may have antibacterial
and anti-
inflammatory action.
Preparations which are applied to the skin such as ROZEX GEL can be
used in combination
with other oral medications prescribed by your doctor.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ROZEX GEL HAS BEEN
PRESCRIBED
FOR YOU. Your doctor may have prescribed it for another reason.
BEFORE YOU USE ROZEX GEL
_WHEN YOU MUST NOT USE IT _
_ _
Do not use ROZEX GEL
•
if you have an allergy to metronidazole or any of inactive ingredients
in the gel
•
if you have or ever have had a blood disorder
•
to treat your child’s skin problem. ROZEX GEL has not been studied
for use in
children
•
if you are pregnant. There are no well-controlled studies of therapy
with ROZEX GEL
in pregnant women.
Symptoms of an allergic reaction may include:
•
swelling of the face, lips, tongue or other parts of the body
•
rash, itching or hives o

Summary of Product characteristics

Page 1 of 5
PRODUCT INFORMATION
ROZEX GEL
_(metronidazole)_
NAME OF THE MEDICINE
ROZEX GEL
(metronidazole 7.5 mg/g)
COMMON NAME
Metronidazole
MOLECULAR FORMULA
C
6
H
9
N
3
O
3
MOLECULAR WEIGHT
171.2
CHEMICAL CLASS
Antiprotozoal and antibacterial agent.
CHEMICAL STRUCTURE
N
N
C H
2
C H
2
O H
O
2
N
C H
3
C
6
H
9
N
3
O
3
; _M_ r 1 7 1 .1 6
DESCRIPTION
Metronidazole 7.5 mg/g in an aqueous gel containing methyl and propyl
hydroxybenzoates,
propylene glycol, carbomer 940, disodium edetate, sodium hydroxide and
purified water.
Metronidazole is 1- (2 hydroxyethyl)-2-methyl-5-nitroimidazole. It is
a white to brownish
crystalline powder that is soluble in water.
PHARMACOLOGY
Metronidazole is an antiprotozoal (trichomoniasis, amoebiasis,
giardiasis) and anaerobic
antibacterial agent. However the mechanisms by which Rozex acts in
reducing inflammatory
lesions of rosacea are unknown, but may include an antibacterial and /
or anti-inflammatory
effect.
_ _
_Pharmacokinetics_
.
The
absorption
of
metronidazole
following
topical
administration
is
negligible.
Studies
on
the
topical
administration
of
1
gram
of
Rozex
(7.5
mg
of
metronidazole) to the face of 10 rosacea patients showed a maximum
serum concentration of
66 nanogram/mL in one patient. This concentration is approximately 100
times less than
concentrations afforded by a single 250 mg tablet. The serum
metronidazole concentrations
were below the detectable limits of the assay at the majority of time
points in all patients.
Three of the patients had no detectable serum concentrations of
metronidazole at any time
point. The mean dose of gel applied during clinical studies was 600
mg, which represents 4.5
mg of metronidazole per application. Therefore under normal usage
levels, the formulation
affords minimal serum concentrations of metronidazole.
INDICATIONS
Treatment of inflammatory papules, pustules and erythema of rosacea.
Page 2 of 5
CONTRAINDICATIONS
Contraindicated
in
individuals
with
a
history
of
hypersensitivity
to
metronidazole,
hydroxybenzoates or other ingredients o