LANTIM 50/5 latanoprost 50 microgram/mL and timolol 5 mg/mL (as maleate) eye drops solution bottle

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

latanoprost,timolol maleate

متاح من:

Juno Pharmaceuticals Pty Ltd

INN (الاسم الدولي):

Latanoprost,Timolol maleate

الوضع إذن:

Registered

نشرة المعلومات

LANTIM 50/5
_Latanoprost 50 ug/mL, _
_Timolol (as maleate) 5 _
_mg/mL eye drops _
CONSUMER
MEDICINE
INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
LANTIM. 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 XANTAPROSTIM
against the benefits it is
expected to 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
XANTAPROSTIM IS
USED FOR
Latanoprost/Timolol eye
drops are 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.
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. If
glaucoma is not treated it
can lead to serious
problems, including total
blindness. In fact, untreated
glaucoma is one of the most
common causes of
blindness.
Latanoprost/Timolol eye
drops are made up of 2
active ingredients,
latanoprost and timolol
maleate. Latanoprost works
by allowing more fluid to
flow out from within your
eye(s). Timolol maleate
lowers the pressure in the
eye by reducing the
production of fluid.
Latanoprost belongs to a
family of medicines called
prostaglandin agonists.
Timolol maleate belongs to
a family of medicines called
betab

خصائص المنتج

1
PRODUCT INFORMATION
LANTIM 50/5
_Latanoprost and Timolol (as maleate) eye drops _
NAME OF THE MEDICINE
LANTIM 50/5 is a combination eye drop containing latanoprost and
timolol maleate.
The chemical name of latanoprost is isopropyl-(Z)-7[(1R,2R,3R,5S)
3,5-dihydroxy-2-[(3R)-3-
hydroxy-5-phenyl-1-pentyl]cyclopentyl]-5-heptenoate,
according
to
IUPAC.
Its
molecular
formula is C
26
H
40
O
5
. The CAS number for latanoprost is 130209-82-4. The chemical
structure
is as follows:
The chemical name of timolol maleate is (S)-1-(
_tert-_
butylamino)-3-[(4-morpholino-1,2,5-
thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Its molecular
formula is C
13
H
24
N
4
O
3
S·C
4
H
4
O
4
. The CAS number for timolol maleate is 26921-17-5. The chemical
structure is as
follows:
DESCRIPTION
The
active
ingredients
in
LANTIM 50/5
eye
drops
are
latanoprost
and
timolol
maleate.
Latanoprost
is a prostaglandin F
2
α
analogue.
It has a molecular weight of 432.58.
It is a
colourless to slightly yellow oil which is practically insoluble in
water, freely soluble in
ethanol,
ethyl
acetate, isopropanol, methanol, acetone and octanol, and very soluble
in
acetonitrile.
Sixty four isomers of latanoprost are possible however, for
latanoprost/timolol eye drops it is
purified as a single isomer.
Timolol maleate is a beta-adrenergic receptor blocking agent. It has a
molecular weight of
432.50. It is a white to off-white crystalline powder which is soluble
in water, alcohol and
practically insoluble in ether.
LANTIM 50/5 is a sterile, isotonic solution containing 50
micrograms/mL of latanoprost and
2
5 mg/mL of timolol (6.83 mg timolol maleate) in an aqueous buffer
solution of pH 6.0. The
excipients are sodium chloride, sodium phosphate – monobasic
dihydrate,
sodium phosphate –
dibasic dodecahydrate, hydrochloric acid, sodium hydroxide, purified
water and benzalkonium
chloride (0.20 mg/mL) as a preservative agent.
The solution is a clear and colourless liquid, filled in a
polyethylene container.
PHARMACOLOGY
PHARMACODYNAMICS
Latanoprost/timolol e