Tenopt 0.5%

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

timolol

Mevcut itibaren:

Mundipharma Pty Ltd

Sınıf:

Medicine Registered

Yetkilendirme durumu:

Registered

Bilgilendirme broşürü

TENOPT
®
_Timolol maleate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TENOPT. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using TENOPT
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TENOPT IS USED
FOR
TENOPT is used to lower raised
pressure in the eye and to treat
glaucoma. Glaucoma is a condition
in which the pressure of fluid in the
eye may be high. However, some
people with glaucoma may have
normal eye pressure. Also, some
people with raised eye pressure may
not have glaucoma.
Glaucoma is usually caused by a
build-up of the fluid which flows
through the eye. This build up occurs
because the fluid drains out of your
eye more slowly than it is being
pumped in. Since new fluid continues
to enter the eye, joining the fluid
already there, the pressure continues
to rise. This raised pressure may
damage the back of the eye resulting
in gradual loss of sight. Damage can
progress so slowly that the person is
not aware of this gradual loss of
sight. Sometimes even normal eye
pressure is associated with damage to
the back of the eye.
There are usually no symptoms of
glaucoma. The only way of knowing
that you have glaucoma is to have
your eye pressure, optic nerve and
visual field checked by an eye
specialist or optometrist. If glaucoma
is not treated it can lead to serious
problems. You may have no
symptoms but eventually glaucoma
can lead to total blindness. In fact,
untreated glaucoma is one of the
most common causes of blindness.
Although TENOPT helps control
your glaucoma it does not cure it.
For more information about
glaucoma, contact Glaucoma
Australia Inc., PO Box 420, Crows
Nest 1585, telephone [phone],
or at www.glaucoma.org.au.
TENO

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TENOPT- Product Information
Page 1 of 11
PRODUCT INFORMATION
TENOPT
®
STERILE Ophthalmic Solution
NAME OF THE MEDICINE
TENOPT
®
(timolol maleate)
0.25% and 0.5%
CAS NUMBER
26921-17-5
CHEMICAL STRUCTURE
Timolol
maleate
is
described
chemically
as
(S)-1-((1,1-dimethylethyl)amino)-3-((4-(4-
morpholinyl)-1,2,5-thiadiazol-3-yl)oxy)-2-propanol,
(Z)-butenedioate(1:1)salt.
Timolol
maleate possesses an asymmetric carbon atom in its structure and is
provided as the levo isomer.
The empirical formula is C
13
H
24
N
4
O
3
S
.
C
4
H
4
O
4
and the structural formula is:
DESCRIPTION
Timolol maleate has a molecular weight of 432.50. It is a white,
odourless, crystalline powder
which is soluble in water, methanol and alcohol. TENOPT is stable at
room temperature.
TENOPT is a clear, colourless to light yellow solution.
Each mL of TENOPT 0.25% contains 2.5 mg of timolol (3.4 mg of timolol
maleate). Each
mL of TENOPT 0.5% contains 5.0 mg of timolol (6.8 mg of timolol
maleate).
TENOPT also contains the following inactive ingredients: monobasic
sodium phosphate
dihydrate, dibasic sodium phosphate dodecahydrate, sodium hydroxide
and water for
injections. Benzalkonium chloride 0.01% is added as preservative.
PHARMACOLOGY
Timolol maleate is a non-selective beta-adrenergic receptor blocking
agent that does not have
significant intrinsic sympathomimetic, direct myocardial depressant,
or local anaesthetic
(membrane-stabilising) activity. Timolol maleate combines reversibly
with a part of the cell
membrane, the beta-adrenergic receptor, and thus inhibits the usual
biological response that
would occur with stimulation of that receptor. This specific
competitive antagonism blocks
stimulation
of
the
beta-adrenergic
receptors
by
catecholamines
having
beta-adrenergic
stimulating (agonist) activity, whether these originate from an
endogenous or exogenous
O
N
N
N
S
OCH
2
CCH
2
NHC
H
OH
CH
3
CH
3
CH
3
.
HC
HC
COOH
COOH
TENOPT- Product Information
Page 2 of 11
source. Reversal of this blockade can be accomplished by increasing
the concentration of t