ALPHAGAN P Ophthalmic Solution 0.1%

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

BRIMONIDINE TARTRATE

Available from:

ABBVIE SDN BHD

INN (International Name):

BRIMONIDINE TARTRATE

Units in package:

5ml in 10ml bottle BOTTLE

Manufactured by:

Allergan Sales, LLC

Patient Information leaflet

ALPHAGAN
® P OPHTHALMIC SOLUTION
brimonidine tartrate (0.1% w/v)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
ALPHAGAN
®
P
0.1%
is
used for
2.
How
ALPHAGAN
® P
0.1%
works
3.
Before
you
use
ALPHAGAN
®
P
0.1%
4.
How to use
ALPHAGAN
® P 0.1%
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ALPHAGAN
® P 0.1%
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ALPHAGAN
® P 0.1%
IS USED
FOR
ALPHAGAN
® P 0.1%
is used to lower
pressure
in
the
eye
of
people
with
glaucoma or high pressure in the eye.
HOW ALPHAGAN
® P 0.1% WORKS
ALPHAGAN
® P 0.1%
is an eye drop
solution that reduces the amount of fluid
flowing into the eye and increases the
amount of fluid flowing out of the eye.
This reduces the pressure inside the eye.
BEFORE YOU USE ALPHAGAN
® P 0.1%
_ _
-
_When you must not use it_
_ _
_ _
Do not use
ALPHAGAN
® P 0.1%
:
-
If you are allergic (hypersensitive
to brimonidine tartrate, or any of
the
other
ingredients
of
ALPHAGAN
® P 0.1%
. (for a full
list
of
ingredients,
see
section
“PRODUCT DESCRIPTION”).
-
If
you
are
taking
monoamine
oxidase antidepressant medication
(MAO)
-
For neonates and infants (children
under the age of 2 years)
If you are not sure whether you should
start
using
ALPHAGAN
®
P
0.1%
,
talk to your doctor.
-
_Pregnancy and lactation _
Discuss with your doctor the possible
risks
and
benefits
of
using
ALPHAGAN
®
P
0.1%
during
pregnancy.
Discuss with your doctor the possible
risks
and
benefits
of
using
ALPHAGAN
® P 0.1%
when breast-
feeding.
-
_Children _
The
safe
and
effective
use
of
ALPHAGAN
®
P
0.1%
in
children
under
the
age
of
2
has
not
been
established.
-
_Before you start use it _
Tell your doctor if:
1.
You have had an allergy to any
other
medicines
or
any
other
substances,
such
as
foods,
preservatives or dyes.
2.
You have or have had any medical
conditions,
especially
the
following:
-
Liver or kidney disease
-
Severe,
uncontrolled
heart
disease, poor blood flow to the
heart

Summary of Product characteristics

TM
ALPHAGAN® P
(brimonidine tartrate ophthalmic solution) 0.1%
sterile
DESCRIPTION
ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0. 1is a
relatively selective alpha-2 adrenergic agonist for ophthalmic use.
The
chemical name of brimonidine tartrate is 5- bromo- 6-
(2-imidazolidinylideneamino) quinoxaline L-tartrate. It has a
molecular weight of 442.24
as the tartrate salt.
The structural formula is:
Formula: C
11
H
10
BrN
5
•C
4
H
6
O
6
CAS Number: 70359-46-5
In solution, ALPHAGAN® P (brimonidine tartrate ophthalmic solution)
0.1% has a clear, greenish-yellow
color. It has an osmolality of 250-320
mOsmol/kg and a pH of 7.4-8.0.
Each mL of ALPHAGAN® P contains:
ACTIVE INGREDIENT:
brimonidine tartrate 0.1% (1.0mg/ml)
PRESERVATIVE:
PURITE® 0.005% (0.05mg/mL)
CLINICAL
PHARMACOLOGY
MECHANISM OF ACTION:
ALPHAGAN® P is an alpha adrenergic receptor agonist. It has a peak
ocular hypotensive effect occurring at two
hours post-dosing. Fluorophotometric
studies in animals and humans suggest that brimonidine tartrate has a
dual mechanism of action by reducing aqueous humor production and
increasing
uveoscleral outflow.
PHARMACOKINETICS:
After ocular administration of either a 0.1% or 0.2% solution, plasma
concentrations peaked within 0.5 to 2.5 hours and declined with a
systemic half-
life of approximately 2 hours. In humans, systemic metabolism
of brimonidine is extensive. It is metabolized primarily by the liver.
Urinary excretion is
the major route of
elimination of the drug and its metabolites. Approximately 87% of an
orally-administered radioactive dose
was eliminated within
120 hours, with 74% found in the urine.
CLINICAL EVALUATIONS:
Elevated IOP presents a major risk factor in glaucomatous field loss.
The higher the level of IOP, the greater
the likelihood of optic nerve damage and
visual field loss. Brimonidine tartrate has the action of lowering
intraocular pressure with minimal effect on cardiovascular and
pulmonary parameters.
A 3-month (with a double-masked extension to 1 year) clinical study
(N=4