Alphagan

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Brimonidine tartrate

Available from:

Allergan Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

ALPHAGAN
® 
Brimonidine Tartrate Eye Drops-CMI   Version 1.0
Page 1 of 4
A
LPHAGAN
®

EYE DROPS
[brimonidine tartrate]
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
ALPHAGAN
® 
eye drops, including
how to use the eye drops.  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
ALPHAGAN
® 
 eye drops against
the benefits they expect it will
have for you.
If you have any concerns about
using/taking this medicine, ask
your doctor or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE.   You may need to read
it again.
WHAT ALPHAGAN
®
 EYE
DROPS ARE USED FOR
ALPHAGAN
® 
 eye drops are used
to lower raised pressure in the eye
and to treat glaucoma.  Glaucoma
is a condition in which the
pressure of fluid in the eye may be
high.  However, some people with
glaucoma may have normal eye
pressure.   Glaucoma is usually
caused by a build up of the fluid
which flows through the eye.  This
build up occurs because the fluid
drains out of your eye more slowly
than it is being pumped in.  Since
new fluid continues to enter the
eye, joining the fluid already there,
the pressure continues to rise.
This raised pressure may damage
the back of the eye resulting in
gradual loss of sight.  Damage
can progress so slowly that the
person is not aware of this gradual
loss of sight.  Sometimes even
normal eye pressure is associated
with damage to the back of the
eye.
There are usually no symptoms of
glaucoma.  The only way of
knowing that you have glaucoma
is to have your eye pressure, optic
nerve and visual field checked by
an eye specialist or optometrist.  If
glaucoma is not treated it can lead
to serious problems, including
total blindness.  In fact, untreated
glaucoma is one of the most
common causes of blindness.
ALPHAGAN
® 
 eye drops are used,
either alone or in combination with
other eye drops/med

Summary of Product characteristics

ALPHAGAN
® 
Eye Drops Product Information - Version 2.0                                                                                 

ALPHAGAN
®
 EYE DROPS 

NAME OF THE DRUG 
The active constituent of A
LPHAGAN

 eye drops is brimonidine tartrate. 

_(structure of brimonidine tartrate) _

CAS Registry No.: 79570-19-7 

DESCRIPTION 
Brimonidine tartrate (A
LPHAGAN

 ophthalmic solution 0.2%) is an alpha-2 selective adrenergic 
agonist for ophthalmic use.  Brimonidine tartrate is an off-white,
pale yellow to pale pink powder 
and is water soluble (34 mg/mL).  In solution,
brimonidine tartrate has a clear, greenish-yellow 
colour. 
CHEMICAL NAME: 5-bromo-6-(2-imidazolidinylideneamino)
quinoxaline L-tartrate.  
MOLECULAR WEIGHT: 442.24 as the tartrate salt. 
EMPIRICAL FORMULA: C
11
H
10
BrN
5
, C
4
H
6
O
6
_ _

A
LPHAGAN

 0.2% is a sterile ophthalmic solution.  Each mL of A
LPHAGAN

 solution contains: 
ACTIVE: brimonidine tartrate 2.0 mg (equivalent to 1.32 mg as
brimonidine free base) 
PRESERVATIVE: benzalkonium chloride 0.05 mg  
INACTIVES: polyvinyl alcohol; sodium chloride; sodium
citrate dihydrate; citric acid 
monohydrate; and purified water.  Hydrochloric acid and/or sodium
hydroxide may be added to 
adjust pH (6.3-6.5). 

PHARMACOLOGY 
_Mechanism of action _
Brimonidine tartrate is an alpha-2 adrenergic agonist that
is 1000-fold more selective for the alpha-2 
adrenoreceptor than the alpha-1 adrenergic receptor.  Affinity at
human alpha-1 and alpha-2 
adrenoreceptors are ~2000 nM and ~2 nM, respectively. This
selectivity results in no mydriasis and 
the absence of vasoconstriction in microvessels associated with human
retinal xenografts. 

Topical administration of brimonidine solution decreases intraocular
pressure (IOP) in humans.  
When used as directed, brimonidine eye drop