OCUDOR -T (Dorzolamide and Timolol Eye Drops BP)

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

DORZOLAMIDE HCL; TIMOLOL MALEATE

Dostupno od:

UNIMED SDN BHD

INN (International ime):

DORZOLAMIDE HCL; TIMOLOL MALEATE

Jedinice u paketu:

5 ml

Proizveden od:

FDC LIMITED

Uputa o lijeku

OCUDOR-T (DORZOLAMIDE AND
TIMOLOL EYE DROP BP)
Dorzolamide Hydrochloride 20mg/mL / Timolol Maleate 5mg/mL
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Ocudor-T Eye Drops is used
for
2.
How Ocudor-T Eye Drops works
3.
Before you use Ocudor-T Eye Drops
4.
How to use Ocudor-T Eye Drops
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Ocudor-T
Eye Drops
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT OCUDOR-T EYE DROPS IS USED FOR
Ocudor-T Eye Drops is comprised of two
components. Dorzolamide Hydrochloride
and Timolol maleate. Dorzolamide
Hydrochloride belongs to a group of
medicines called “carbonic anhydrase
inhibitors”. Timolol belongs to a group
of medicines called “Beta-Blocker”.
HOW OCUDOR-T EYE DROPS IS WORKS
Each of these two components decrease
elevated intraocular pressure, whether or
not associated with glaucoma, by
reducing secretion of fluid in the eye.
BEFORE YOU USE OCUDOR-T EYE DROPS_ _
_When you must not use it _
Do not use Ocudor -T Eye Drops If you
have:
•
If you are allergic to dorzolamide
or timolol or any of the other
ingredients of this medicine.
•
If you have now or had in the past
respiratory problem, such as
asthma or lung disease which may
cause wheeziness, difficulty in
berating or long-standing cough
•
If you have a slow heartbeat, heart
failure or irregular heartbeats.
If this applies to you, tell your doctor
immediately and don’t use Ocudor-T Eye
Drops.
-
_ Before you start to use it _
Talk to your doctor or pharmacist before
using Ocudor-T Eye Drops if you:
•
Have history of Cardiac failure
•
Have Lungs disease
•
Have Diabetes
•
Overactivity of the thyroid gland
•
About to undergo surgery
•
Wear contact lenses
-
_Taking other medicines _
Tell your doctor if you are using or
intend to use any other medicines to
lower blood pressure, heart medicines
or medicines to treat diabetes.
Tell your doctor if you are particularly
taking:
•
Tak

Svojstava lijeka

For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only
OCUDOR-T
Dorzolamiae ana Timolol c�e Dro�s ��
COMPOSITION
Each ml CONTAINS
Dorzolamide (as 22.26mg Dorzolamide Hydrochloride) Ph. Eur .........
20 mg
Timolol (as 6.83 mg Timolol Maleale)Ph. Eur
................................... 5 mg
Benzalkonium Chloride Ph.Eur
...............................................
0.075 mg
(As Preservative)
Aqueous Buffered Vehicle
...............................................................
q.s.
DESCRIPTION
OCUDOR T (Dorzolamide and limolol Eye drops BP) is Clear, colourless,
slightly viscous
solution, practically free from visible particles, filled into 5 ml
low density polyethylene (LOPE)
containers having blue insert cap assembly.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS / MECHANISM OF ACTION
OCUDOR T is comprised of two components: dorzolamide hydrochloride and
timolol maleate.
Each of these two components decreases elevated intraocular pressure
by reducing aqueous
humor secretion, but does so by a different mechanism of action.
Dorzolamide hydrochloride is a potent inhibitor of human carbonic
anhydrase II.Inhibition of
carbonic anhydrase in the ciliary processes of the eye decreases
aqueous humor secretion,
presumably by slowing the formation of bicarbonate ions with
subsequent reduction in sodium
and fluid transport. Timolol maleate is a nonselective beta-adrenergic
receptor blocking agent
that does not have significant intrinsic sympathomimetic, direct
myocardial depressant, or
local anesthetic (membrane-stabilizing) activity. The combined effect
of these two agents
results in additional intraocular pressure (IOP) reduction compared to
either component
administered alone.
Following topical administration, OCUDOR T reduces elevated
intraocular pressure, whether
or not associated with glaucoma. Elevated intraocular pressure is a
major risk factor in the
pathogenesis of optic nerve damage and glaucomatous visual field loss.
The higher the level of
intraocular pressure, the greater the li