ALPHAGAN OPHTHALMIC SOLUTION 0.2%

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

BRIMONIDINE TARTRATE

Pieejams no:

Allergan Malaysia Sdn Bhd

SNN (starptautisko nepatentēto nosaukumu):

BRIMONIDINE TARTRATE

Vienības iepakojumā:

5ml mL

Ražojis:

ALLERGAN PHARMACEUTICALS IRELAND

Lietošanas instrukcija

ALPHAGAN
®
EYE DROPS
brimonidine tartrate (0.2% w/v)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What ALPHAGAN
®
is used for
2.
How ALPHAGAN
®
works
3.
Before you use ALPHAGAN
®
4.
How to use ALPHAGAN
®
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ALPHAGAN
®
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of revision
What ALPHAGAN
®
is used for
ALPHAGAN
®
is used to lower pressure
in the eye of people with glaucoma or
high pressure in the eye.
How ALPHAGAN
®
works
ALPHAGAN
®
is an eye drop solution
that
reduces
the
amount
of
fluid
produced in the eye and increases the
amount of fluid flowing out of the eye.
This reduces the pressure inside the eye.
Before you use ALPHAGAN
®
-
When you must not use it
Do not use ALPHAGAN
®
:
- If you are allergic (hypersensitive
to brimonidine tartrate, or any of
the
other
ingredients
of
ALPHAGAN
®
. (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
®
, talk to your
doctor.
- Pregnancy and lactation
Discuss with your doctor the possible
risks
and
benefits
of
using
ALPHAGAN
®
during pregnancy.
Discuss with your doctor the possible
risks
and
benefits
of
using
ALPHAGAN
®
when breast-feeding.
- Children
The
safe
and
effective
use
of
ALPHAGAN
®
in children under the
age of 2 has not been established.
In children 2 years of age and above,
especially
those
weighing
≤
20kg,
ALPHAGAN
®
should
be
used
with
caution and closely monitored due to
the
high
incidence
and
severity
of
sleepiness.
- 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
heart
or
blood
vess

Produkta apraksts

ALPHAGAN ®
Brimonidine tartrate
ophthalmic solution 0.2%
DESCRIPTION
Each mL contains: brimonidine tartrate 2 mg (equivalent to 1.32 mg as brimonidine free base) with:
benzalkonium chloride 0.05 mg, polyvinyl alcohol 14 mg; sodium chloride; sodium citrate; citric acid and
purified water.
CLINICAL PHARMACOLOGY
ALPHAGAN ® is a relatively selective alpha- 2 adrenergic 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.
After ocular administration of a 0.2% solution, plasma concentrations peaked within 1 to 4 hours and
declined with a system ic half -life of approximately 3 hours.
In humans, system ic 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.
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. ALPHAGAN
® has the action of lowering
intraocular pressure with minimal effect on cardiovascular and pulmonary parameters.
In comparative clinical studies with timolol 0.5%, lasting up to one year, the IOP lowering effect of
ALPHAGAN ® was approximately 4 -6 mm Hg compared with approximately 6 mm Hg for timolol. Eight
percent of subjects were discontinued from studies due to inadequately controlled intraocular pressure,
which in 30% of these patients occurred during the first month of therapy. Approximately 20% were
discontinued due to adverse experiences.
INDICATIONS AND USAGE
ALPHAGAN ® is indicated for lowering intraocular pressure in patients with open- angle glaucoma or ocular
hypertension. The IOP lowering efficacy of ALPHAGAN ® ophthalmic