MIRVASO brimonidine 3.3 mg/g (as tartrate) gel tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

brimonidine tartrate, Quantity: 5 mg/g (Equivalent: brimonidine, Qty 3.3 mg/g)

Available from:

Galderma Australia Pty Ltd

INN (International Name):

brimonidine tartrate

Pharmaceutical form:

Gel

Composition:

Excipient Ingredients: carbomer 974P; methyl hydroxybenzoate; phenoxyethanol; glycerol; titanium dioxide; propylene glycol; sodium hydroxide; purified water

Administration route:

Topical

Units in package:

2 g Physician's sample pack, 30 g, 10 g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MIRVASO is indicated for the treatment of facial erythema of rosacea in adult patients

Product summary:

Visual Identification: White to light yellow opaque gel; Container Type: Tube; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-08-04

Patient Information leaflet

MIRVASO Consumer Medicine Information version 6_ _
_Page _1 of 4
MIRVASO
 GEL

_Brimonidine 3.3mg/g_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
MIRVASO
. 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
MIRVASO
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 MEDICINE.
You may need to read it again.
WHAT MIRVASO IS USED
FOR
MIRVASO
contains the active
ingredient brimonidine tartrate that
belongs to a group of substances known
as alpha
2
-adrenergic receptor agonists.
MIRVASO
is used for treating skin of
the face affected by redness due to
rosacea in adult patients.
When applied to the skin,
MIRVASO
gel passes through the skin and acts
specifically on the blood vessels of the
face to decrease the redness of rosacea.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY MIRVASO HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
MIRVASO
is not addictive.
MIRVASO
is available only with a
doctor’s prescription.
BEFORE YOU USE
MIRVASO
_WHEN YOU MUST NOT USE IT _
DO NOT USE MIRVASO:

for any child or adolescents under 18
years of age

if you are breast-feeding

if you are taking medicines for
depression called monoamine
oxidase inhibitors (eg. Nardil,
Parnate) or tricyclic antidepressants
(such as imipramine) or tetracyclic
antidepressants (such as maprotiline,
mianserin or mirtazapine).

if you have an allergy to any
medicine containing brimonidine
tartrate

if you have an allergy to any of the
ingredients listed at the end of this
leaflet
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or
other parts of the body

rash, itchin

Summary of Product characteristics

_Version 5_
1
PRODUCT INFORMATION
NAME OF THE MEDICINE
MIRVASO Gel: brimonidine 3.3 mg/g
AUSTRALIAN APPROVED NAME (AAN):
brimonidine tartrate
CHEMICAL NAMES:
5-Bromo-N-(4,5-dihydro-1
_H_
-imidazol-2-yl)-6-quinoxalinamine L-
(+)-tartrate; 5-Bromo-6-(2-imidazolin-2-ylamino)quinoxaline
L-(+)-tartrate
MOLECULAR FORMULA:
C
11
H
10
BrN
5.
C
4
H
6
O
6
MOLECULAR WEIGHT:
442.2 as the tartrate salt
STRUCTURAL FORMULA:
brimonidine tartrate
CAS NUMBER:
70359-46-5
DESCRIPTION
MIRVASO is a white to light-yellow opaque gel. One gram of MIRVASO gel
contains
brimonidine tartrate equivalent to brimonidine 3.3 mg.
LIST OF EXCIPIENTS
Carbomer 934P
Methyl hydroxybenzoate (E218)
Phenoxyethanol
Glycerol
Titanium dioxide
Propylene glycol
Sodium hydroxide
Purified water
PHARMACOLOGY
MECHANISM OF ACTION AND PHARMACODYNAMIC EFFECTS
Brimonidine
is
a
selective

2
-adrenergic
receptor
agonist
that
is
1000-fold
more
selective for the

2
-adrenergic receptor than the

1-adrenergic receptor.
Topical facial application of a highly selective

2
-adrenergic receptor agonist is intended to reduce
erythema through direct cutaneous vasoconstriction.
_Version 5_
2
PHARMACOKINETICS
The absorption of brimonidine from MIRVASO was evaluated in a relative
bioavailability study
in 23 adults with facial erythema of rosacea. All enrolled patients
received 1 drop every 8 hours
of a brimonidine 0.2% eye drops solution for 24 hours,
followed by a once daily cutaneous
application of the maximal quantity (1g) of MIRVASO for 29 days
(intra-individual comparison
of systemic exposure). After
repeated cutaneous application of MIRVASO on facial skin, no
drug accumulation in plasma was observed throughout the treatment
duration: the highest mean
(± standard deviation) plasma maximum concentration (Cmax) and area
under the concentration-
time curve from 0 to 24 hours (AUC0-24hr) were 46 ± 62 pg/mL and 417
± 264
pg.hr/mL
respectively. These levels are comparable to those obtained in
patients treated with a 0.2% eye
drops solution of brimonidine.
The pharmaco