Xalanol Eye Drops

देश: मलेशिया

भाषा: अंग्रेज़ी

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

सक्रिय संघटक:

LATANOPROST; TIMOLOL MALEATE

थमां उपलब्ध:

Vitamode Sdn.bhd

INN (इंटरनेशनल नाम):

LATANOPROST; TIMOLOL MALEATE

पैकेज में यूनिट:

2.5 ml

द्वारा बनाया गया:

BEXIMCO PHARMACEUTICAL LTD

सूचना पत्रक

XALANOL
®
EYE DROPS
latanoprost (0.05mg/ml) & timolol maleate as timolol (5mg/ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Xalanol Eye Drops _
is used for
2.
How
_Xalanol Eye Drops _
works
3.
Before you use
_Xalanol Eye Drops_
4.
How to use
_Xalanol Eye Drops_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Xalanol Eye _
_Drops _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _XALANOL EYE DROPS _IS USED FOR
_Xalanol Eye Drops_
is used for the
treatment of open angle glaucoma or
ocular hypertension. Both these
conditions are linked with an increase in
the pressure within the eyes, eventually
affecting the eye sight.
HOW _XALANOL EYE DROPS _WORKS
Latanoprost works by reduction of
elevated intraocular pressure within the
eyes by increasing the natural out flow of
fluid from inside the eye into the blood
stream.
Timolol works by slowing the formation
of fluid in the eye
BEFORE YOU USE _XALANOL EYE DROPS _
_-When you must not use it _
Do not use
_Xalanol Eye Drops,_
• If you are allergic to either Latanoprost,
Timolol or any of the other ingredients in
this medicine
• If you have difficulty in breathing
because of lung disease or problem with
your lungs.
• If you having any heart disease
_. _
_ _
_Pregnancy and lactation _
Do not take
_Xalanol Eye Drops _
if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take
_Xalanol Eye Drops _
if you
are breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
_ _
_ _
_ _
_ _
_ _
_ _
-
_Before you start to use it _
Talk to your doctor or pharmacist before
using XALANOL if you have now or
have had in the past:
-
Coronary heart disease – symptoms
can include chest pain or tightness,
breathlessness or choking, heart
failure, low blood pressure
(hypotension)
-
Disturbances of heart rate such as
slow heart beat (bradycardia)
-
Breathing problems, asthma or
chronic obstructive pulmonary
disease (lung diseas

उत्पाद विशेषताएं

Xalanol® Eye Drops
Latanoprost 0.05mg/ml &
Timolol maleate as Timolol 5mg/ml
DESCRIPTION
Colourless or pale yellow, clear solution.
PHARMACODYNAMICS
_Mechanism of action_
Xalanol consists of two components: latanoprost and timolol maleate.
These two components decrease
elevated intraocular pressure (IOP) by different mechanisms of action
and the combined effect results in
additional IOP reduction compared to either compound administered
alone.
Latanoprost, a prostaglandin F
2alpha
analogue, is a selective prostanoid FP receptor agonist that reduces
the
IOP by increasing the outflow of aqueous humour. The main mechanism of
action is increased
uveoscleral outflow. Additionally, some increase in outflow facility
(decrease in trabecular outflow
resistance) has been reported in man. Latanoprost has no significant
effect on the production of aqueous
humour, the blood-aqueous barrier or the intraocular blood
circulation. Chronic treatment with latanoprost
in monkey eyes, which had undergone extracapsular lens extraction did
not affect the retinal blood vessels
as determined by fluorescein angiography. Latanoprost has not induced
fluorescein leakage in the
posterior segment of pseudophakic human eyes during short term
treatment.
Timolol is a beta-1 and beta-2 (non-selective) adrenergic receptor
blocking agent that has no significant
intrinsic sympathomimetic, direct myocardial depressant or
membrane-stabilising activity. Timolol
lowers IOP by decreasing the formation of aqueous in the ciliary
epithelium.
The precise mechanism of action is not clearly established, but
inhibition of the increased cyclic AMP
synthesis caused by endogenous beta-adrenergic stimulation is
probable. Timolol has not been found to
significantly affect the permeability of the blood-aqueous barrier to
plasma proteins. In rabbits, timolol
was without effect on the regional ocular blood flow after chronic
treatment.
Pharmacodynamic effects
_Clinical effects_
Xalanol produced significantly greater decreases in mean diurnal IOP
compared to latanoprost