LATANOCOM latanoprost 50 microgram/mL, timolol (as maleate) 5 mg/mL eye drops

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

timolol maleate, Quantity: 6.83 mg/mL (Equivalent: timolol, Qty 5 mg/mL); latanoprost, Quantity: 0.05 mg/mL

Inapatikana kutoka:

Aspen Pharmacare Australia Pty Ltd

INN (Jina la Kimataifa):

Latanoprost,Timolol maleate

Dawa fomu:

Eye Drops, solution

Tungo:

Excipient Ingredients: sodium hydroxide; benzalkonium chloride; dibasic sodium phosphate; water for injections; sodium chloride; hydrochloric acid; monobasic sodium phosphate monohydrate

Njia ya uendeshaji:

Ophthalmic

Vitengo katika mfuko:

1 x 2.5 mL

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

The reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. LATANOCOM should not be used to initiate therapy.

Bidhaa muhtasari:

Visual Identification: clear, colourless liquid; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2012-03-30

Taarifa za kipeperushi

LATANOCOM
®
_EYE DROPS_
_Latanoprost/Timolol maleate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Latanocom. 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 Latanocom
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 LATANOCOM IS
USED FOR
Latanocom 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.
_HOW LATANOCOM WORKS_
Latanocom 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
reducing the production of fluid.
Latanoprost belongs to a family of
medicines called prostaglandin
agonists. Timolol maleate belongs to
a family of medicines called beta-
blockers.
Although Latanocom helps control
your g

Tabia za bidhaa

Version: pfplatae10317
Supersedes: pfplatae10114
Page 1 of 15
PRODUCT INFORMATION
LATANOCOM

(LATANOPROST AND TIMOLOL)
NAME OF THE MEDICINE
Latanocom
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:
OH
OH
OH
COOCH(CH
3
)
2
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 Latanocom eye drops are latanoprost and
timolol maleate. Latanoprost is a
prostaglandin F
2

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 Latanocom
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.
N
S
N
O
N
O
N
H
H
OH
H
3
C
CH
3
CH
3
+
HO
O
O
OH
N
S
N
O
N
O
N
H
H
OH
H
3
C
CH
3
CH
3
+
HO
O
O
OH
Version: pfplatae10317
Supersedes: pfplatae10114
Page 2 of 15
Latanocom 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
Latanocom are sodium chloride, sodium phosphate monobasic monohydrate,
sodium phosphate
dibasic anhydrous, hydrochloric acid, sodium hydroxide, Water for