Corneax eye drops solution 0.2% wv

País: Malàisia

Idioma: anglès

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

ingredients actius:

BRIMONIDINE TARTRATE

Disponible des:

AVERROES PHARMACEUTICALS SDN. BHD.

Designació comuna internacional (DCI):

BRIMONIDINE TARTRATE

Unidades en paquete:

1 BOTTLE

Fabricat per:

COOPER S.A.

Informació per a l'usuari

CORNEAX, EYE DROPS SOLUTION 0.2% W/V
Brimonidine tartrate 0.2% w/v
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Corneax is used for
2.
How Corneax works
3.
Before you use Corneax
4.
How to use Corneax
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Corneax
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CORNEAX
IS USED FOR
CORNEAX is used to reduce pressure
within
the
eye.
It
can
be
used
either
alone, when beta-blocker eye drops are
contraindicated,
or
with
another
eye
drop,
when
a
single
medicine
is
not
enough to lower the increased pressure in
the eye, in the treatment of open angle
glaucoma or ocular hypertension.
HOW CORNEAX WORKS
The active ingredient in CORNEAX is
brimonidine
tartrate,
which
works
by
reducing pressure within the eyeball.
BEFORE YOU USE CORNEAX
-
_When you must not use it _
Do not use CORNEAX
•
If
you
are
allergic
(hypersensitive) to brimonidine tartrate
or any of the other ingredients of this
medicine.
•
If
you
are
taking
monoamine
oxidase
(MAO)
inhibitors
or
certain
antidepressants. You must inform your
doctor
if
you
are
taking
any
antidepressant drug.
•
If you are breast-feeding.
•
In
infants/babies
(from
birth
until 2 years).
_Pregnancy and lactation _
Ask your doctor or pharmacist for advice
before taking any
medicine. Tell your
doctor if you are pregnant or planning to
become pregnant.
CORNEAX
should
not
be
used
while
breast-feeding
_ _
-
_Before you start use it _
_ _
Before you take this medicine, tell your
doctor:
•
If you suffer or have suffered
from
depression,
reduced
mental
capacity,
reduced
blood
supply
to
the
brain,
heart
problems,
a
disturbed
blood supply of the limbs or
a blood pressure disorder.
•
If you have or have had in
the
past
kidney
or
liver
problems
•
If
being
given
to
a
child
between the age of 2 and 12
years because CORNEAX is
not recommended for use in
this age group.
-
_Taking other medicines _
_ _
Please tell your doctor or pharmacist if
yo

Fitxa tècnica

CORNEAX, EYE DROPS SOLUTION 0.2% W/V
BRIMONIDINE TARTRATE
PRODUCT NAME
Corneax 0.2% w/v eye drops, solution
PRODUCT DESCRIPTION
Eye drops, solution.
Clear, greenish-yellow to light greenish-yellow solution.
COMPOSITION
Each ml contains 2 mg brimonidine tartrate, equivalent to 1.3 mg of
brimonidine.
PHARMACODYNAMICS
Pharmacotherapeutic group: Sympathomimetics in glaucoma therapy, ATC
code = S01EA 05.
Brimonidine is an alpha-2 adrenergic receptor agonist that is
1000-fold more selective for the
alpha-2 adrenoceptor than the alpha-1 adrenoreceptor.
This selectivity results in no mydriasis and the absence of
vasoconstriction in microvessels
associated with human retinal xenografts.
Topical administration of brimonidine tartrate decreases intraocular
pressure (IOP) in humans
with minimal effect on cardiovascular or pulmonary parameters.
Limited data are available for patients with bronchial asthma showing
no adverse effects.
Corneax has a rapid onset of action, with peak ocular hypotensive
effect seen at two hours post-
dosing. In two 1 year studies, Corneax lowered IOP by mean values of
approximately 4-6
mmHg.
Fluorophotometric studies in animals and humans suggest that
brimonidine tartrate has a dual
mechanism of action. It is thought that Corneax may lower IOP by
reducing aqueous humour
formation and enhancing uveoscleral outflow.
Clinical trials show that Corneax is effective in combination with
topical beta-blockers. Shorter
term studies also suggest that Corneax has a clinically relevant
additive effect in combination
with travoprost (6 weeks) and latanoprost (3 months).
PHARMACOKINETICS
a) General characteristics
After ocular administration of a 0.2% solution twice daily for 10
days, plasma concentrations
were low (mean Cmax was 0.06 ng/ml). There was a slight accumulation
in the blood after
multiple (2 times daily for 10 days) instillations. The area under the
plasma concentration-time
curve
over 12 hours at steady state (AUC 0-12h) was 0.31 ng·hr/ml, as
compared to 0.23
ng·hr/ml after the first dose.
The me