资料单张
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
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产品特点
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
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