NYOGEL timolol 1mg/g (as maleate) eye gel bottle

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

timolol maleate

Sẵn có từ:

Aspen Pharma Pty Ltd

INN (Tên quốc tế):

Timolol maleate

Tình trạng ủy quyền:

Registered

Tờ rơi thông tin

Nyogel
®
1
NYOGEL
®
_timolol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nyogel.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP-TO-DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP-TO-
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Nyogel 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 NYOGEL IS USED
FOR
This medicine is used to lower the
pressure in the eye and to prevent
loss of vision in glaucoma.
It works by decreasing the formation
of fluid which flows through the eye.
The eye is filled with fluid which is
constantly being replaced. If
excessive amounts of fluid are
produced or if it cannot drain away
properly, the pressure inside the eye
can damage the nerve cells that
transmit information from the eye to
the brain. This nerve cell damage is
called glaucoma.
Glaucoma is often but not always
associated with increased pressure in
the eye. A reduction of the pressure
inside the eye can prevent further
nerve cell damage.
There are usually no symptoms of
glaucoma. Damage can progress so
slowly that you are not aware of a
gradual loss of sight. The only way
of knowing 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

Đặc tính sản phẩm

1
NYOGEL

(TIMOLOL AS MALEATE)
NAME OF THE MEDICINE
Active ingredient:
timolol maleate
Chemical name:
(S)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-
thiadiazol-3-yl]-2-propanol maleate
Molecular formula:
C
13
H
24
N
4
O
3
S.C
4
H
4
O
4
CAS number:
26921-17-5
Molecular weight
432.49
Structural formula:
DESCRIPTION
Nyogel contains timolol 1 mg/g (as timolol maleate 1.37 mg/g).
Excipients: benzalkonium chloride, carbomer 934P (974 P grade), lysine
monohydrate,
polyvinyl alcohol, sodium acetate, sorbitol and water for injections.
PHARMACOLOGY
PHARMACODYNAMICS
Timolol is a non-selective beta-blocker that does not have any
significant cardiac
stimulating or direct cardiac depressant or local anaesthetic
(membrane stabilising)
activity. When applied topically in the eye, it reduces both elevated
and normal
intraocular pressure. Although not all mechanisms of action of timolol
are known yet, it
is thought to primarily reduce the production of aqueous humor. It may
also have a
lesser effect on the outflow of aqueous humor.
Unlike miotics, timolol reduces intraocular pressure with little
effect on pupil size or
visual acuity. Thus, impairment of vision or night blindness does not
occur as with the
use of miotics. In cataract patients, the impairment of vision, caused
by lenticular
opacities when the pupil is constricted, is avoided
.
The onset of reduction in intraocular pressure following ocular
administration of timolol
ophthalmic solution occurs approximately 20 minutes after eye drop
administration. The
maximum effect is achieved within about 1 to 2 hours from
administration and
2
significant lowering of intraocular pressure can be maintained for
periods as long as 24
hours.
PHARMACOKINETICS
Nyogel is an eye-drop formulation in gel form, which due to the
particular chemical
characteristics, maximises the drug absorption in the eye and reduces
its absorption into
the systemic circulation.
Pharmacokinetic data from studies in 24 healthy volunteers have shown
that the mean
value of the maximum plasma concentration is