Latanoprost/Timolol AN 50/5 latanoprost 50 microgram/mL + timolol (as maleate) 5 mg/mL eye drop solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

latanoprost,timolol maleate

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

Latanoprost,Timolol maleate

Authorization status:

Registered

Patient Information leaflet

_Latanoprost/timolol eye drops – Consumer Medicine Information _
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_Latanoprost/Timolol AN 50/5 CMI v 1.0 _
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LATANOPROST/ TIMOLOL AN 50/5 EYE
DROPS
_Latanoprost/Timolol maleate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Latanoprost/ timolol AN 50/5. 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
Latanoprost/ timolol AN 50/5
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 LATANOPROST/
TIMOLOL AN 50/5 IS
USED FOR
Latanoprost/ timolol AN 50/5 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.
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 AN 50/5 is
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
reduc

Summary of Product characteristics

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PRODUCT INFORMATION
LATANOPROST/TIMOLOL AN 50/5
(LATANOPROST AND TIMOLOL)
NAME OF THE MEDICINE
Latanoprost/Timolol AN 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 Latanoprost/Timolol AN 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 AN 50/5 it is
purified as a single isomer.
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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.
Latanoprost/Timolol AN 50/5 is a sterile, isotonic solution containing
50 micrograms/mL of
latanoprost and 5 mg/mL of timolol (6.83 mg timolol maleate) in an
aqueous buffer solution
of
pH
6.0. The
excipients in Latanoprost/Timolol AN 50/5 are sodium chloride, sodium
phosphate monobasic monohydrate,
sodium phosphate dibasic anhydrous, hydrochloric acid,
sodium
hydroxide,
Water
for
Injections and benzalkonium chloride (0.20 mg/mL)