Alphagan P

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 P
®
 Consumer Medicine Information leaflet Version 1.0 

 Page 1 of 4 

ALPHAGAN

 P 1.5 
EYE DROPS
_ _ 
[brimonidine tartrate 1.5 mg/mL] 

CONSUMER MEDICINE 
INFORMATION   

WHAT IS IN THIS LEAFLET 

This leaflet answers some 
common questions about 
ALPHAGAN

 P 1.5 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 benefits and 
risks.  Your doctor has weighed 
the risks of you using 
ALPHAGAN

 P 1.5 eye drops 
against the benefits they expect it 
will have for you. 

If you have any concerns about 
using this medicine, ask your 
doctor or pharmacist. 

KEEP THIS LEAFLET WITH THE 
MEDICINE.   You may need to read 
it again. 

WHAT ALPHAGAN

 P 1.5 
EYE DROPS ARE USED FOR 

ALPHAGAN

 P 1.5 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. 

Eye 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

Summary of Product characteristics

ALPHAGAN
® 
P
 1.5 EYE DROPS 

NAME OF THE DRUG 
The active constituent of A
LPHAGAN

 P 1.5 eye drops is brimonidine tartrate. 

_(structure of brimonidine tartrate) _

CAS Registry No.: 79570-19-7 

DESCRIPTION 
Brimonidine tartrate is an off-white, pale yellow to pale pink
powder and is soluble in water (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

 P 1.5 0.15% is a sterile ophthalmic solution.  Each mL of A
LPHAGAN

 P 1.5 solution 
contains: 
ACTIVE: brimonidine tartrate 1.5 mg (equivalent to 0.99 mg as
brimonidine free base) 
PRESERVATIVE: Sodium chlorite (as PURITE)

1.8µg 
INACTIVES: Carmellose sodium, boric acid, borax, sodium chloride,
potassium chloride, calcium 
chloride dihydrate, magnesium chloride hexahydrate, and purified
water.  Hydrochloric acid and/or 
sodium hydroxide may be added to adjust pH (6.6-7.4) 

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.
 Affinities 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 drops have the action
of reducing elevated IOP with 
minimal effect on cardiovascular parameters. 

Brimonidine has a rapid onset of action, with the peak ocular
hypotensive effect occurring at two 
hours post-dosing.  The duration of effect is 12 h