Alphagan P Ophthalmic Solution 0.15 %

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:

3ml mL; 5ml mL; 10ml mL; 15ml mL

Manufactured by:

Allergan Sales, LLC

Patient Information leaflet

ALPHAGAN
® P OPHTHALMIC SOLUTION
brimonidine tartrate (0.15% w/v)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
ALPHAGAN
® P
is used for
2.
How
ALPHAGAN
® P
works
3.
Before you use
ALPHAGAN
® P
4.
How to use
ALPHAGAN
® P
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ALPHAGAN
® P
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ALPHAGAN
® P
IS USED FOR
ALPHAGAN
®
P
is
used
to
lower
pressure
in
the
eye
of
people
with
glaucoma or high pressure in the eye.
HOW ALPHAGAN
® P WORKS
ALPHAGAN
® P
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
_ _
-
_When you must not use it_
_ _
_ _
Do not use
ALPHAGAN
® P
:
-
If you are allergic (hypersensitive
to brimonidine tartrate, or any of
the
other
ingredients
of
ALPHAGAN
® P
. (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
, talk to
your doctor.
-
_Pregnancy and lactation _
Discuss with your doctor the possible
risks
and
benefits
of
using
ALPHAGAN
® P
during pregnancy.
Discuss with your doctor the possible
risks
and
benefits
of
using
ALPHAGAN
® P
when breast-feeding.
-
_Children _
The
safe
and
effective
use
of
ALPHAGAN
® P
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 or recurring inflammation
and
clotting
of
small
and
medium
blood
vessels
of
the

Summary of Product characteristics

ALPHAGAN
® P
(brimonidine tartrate ophthalmic solution) 0.15%
sterile
DESCRIPTION
ALPHAGAN
®
P (brimonidine tartrate ophthalmic solution) 0.15% is 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 is an
off-white to pale yellow powder. It
has a molecular weight of 442.24 as the tartrate salt, and is both
soluble in water (1.5 mg/mL)
and in the product vehicle (3.0 mg/mL) at pH 7.2.
The structural formula is:
Formula: C
11
H
10
BrN
5
•C
4
H
6
O
6
CAS Number: 59803-98-4
In solution, ALPHAGAN
®
P (brimonidine tartrate ophthalmic solution) 0.15% has a clear,
greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a
pH of 6.6-7.4.
Each mL of ALPHAGAN
®
P contains:
ACTIVE INGREDIENT: brimonidine tartrate 0.15% (1.5 mg/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 press