Metronidazole Gel 0.5%

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metronidazole, Quantity: 5 mg/mL

Available from:

Orion Laboratories Pty Ltd T/A Perrigo Australia

INN (International Name):

Metronidazole

Pharmaceutical form:

Gel

Composition:

Excipient Ingredients: water for injections; propylene glycol; citric acid; hyetellose; dibasic sodium phosphate heptahydrate

Administration route:

Topical

Units in package:

10g

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Metronidazole Gel is indicated for the treatment of inflammatory papules and pustules of rosacea.

Product summary:

Visual Identification: Clear colourless gel; Container Type: Tube

Authorization status:

Registered

Authorization date:

1991-07-09

Patient Information leaflet

METRONIDAZOLE GEL
_Metronidazole 0.5% w/w _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET?
Metronidazole Gel
Page 1 of 3
Please read this leaflet
carefully before you start using
Metronidazole Gel.
This leaflet answers some
common questions about
Metronidazole Gel. It does not
contain all the available
information.
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 you using
Metronidazole Gel against the
benefits they expect it will have
for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with your tube.
You may wish to read it again
later.
WHAT IS
METRONIDAZOLE GEL
USED FOR?
Metronidazole 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.
Your doctor may have
prescribed Metronidazole Gel
for another use. Ask your
doctor if you have any
questions about why
Metronidazole Gel has been
prescribed for you.
The active ingredient in
Metronidazole Gel is
metronidazole, which belongs
to the class of medicines
known as anitprotozoals and
antibacterials.
It is not clear how
Metronidazole Gel works
however it is known to have
antibacterial and anti-
inflammatory properties.
In many cases medications
may take several weeks to
show an effect. They may
have to be used regularly to
keep the rosacea under control.
This medicine is only available
with a doctor’s prescription.
BEFORE YOU USE
METRONIDAZOLE GEL
_DO NOT USE IF: _
You must not use
Metronidazole Gel if you have
an allergy to:
¾
Metronidazole
¾
Any of the ingredients
listed at the end of this
leaflet (See “Ingredients”)
Metronidazole Gel is not
recommended for children as
there is not enough information
on its use in that age group.
_TELL YOUR DOCTOR IF: _
You must tell your docto

Summary of Product characteristics

Metronidazole Gel
Page 1 of 4
PRODUCT INFORMATION
METRONIDAZOLE GEL
:
g Metronidazole BP 0.5%, the pH of the gel is 4.5 to 6.0.
:
171.2
white or yellowish, crystalline powder. It is slightly soluble in
water, in alcohol,
ichloromethane. It is very slightly soluble in ether. It darkens on
exposure to
osphate dibasic anhydrous, citric acid – anhydrous, propylene
glycol,
thylcellulose, purified water.
PHARMACOLOGY:
COMPOSITION
A sterile gel containin
DESCRIPTION
Metronidazole is 2-(2-methyl-5-nitroimidazol-l-yl)ethanol.
C
6
H
9
N
3
O
3
MW=
CAS Number = 443-48-1
Metronidazole is a
in acetone and in d
light and should be protected from light.
_EXCIPIENTS: _
Sodium ph
hydroxye
Metronidazole is a synthetic nitroimidazole derivative. It is an
anaerobic antibacterial agent and an
antiprotozoal (trichomoniasis, amoebiasis, giardiasis). However, the
mechanisms by which
Metronidazole Gel acts in reducing inflammatory lesions of rosacea are
unknown, but may include
an antibacterial and/or anti-inflammatory effect.
PHARMACOKINETICS:
dies using Rozex
) to the face of
detectable to a
es less than
oncentrations were
nts. Three of the
e point. The mean
mg of
re, under normal usage levels, the formulation affords
um concentrations of metronidazole.
INDICATIONS:
s indicated for the treatment of inflammatory papules and pustules of
rosacea.
CONTRA-INDICATIONS:
le is contra-indicated in individuals with a history of
hypersensitivity to metronidazole,
r any of the other ingredients in the formulation.
Topical metronidazole preparations have been reported to cause watery
or tearing eyes when
applied too close to the eyes. Contact with the eyes should therefore
be avoided.
If a reaction suggesting local irritation occurs, patients should be
directed to use the medication
less frequently or discontinue use.
The absorption of metronidazole following topical administration is
negligible. Stu
Gel, another metronidazole (0.75%) gel preparation, have shown that
following topical
administration of 1 gram of a metronidazole gel (containing 7.5