DORZOLAMIDE/TIMOLOL SANDOZ 20/5 dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drops solution bott

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dorzolamide hydrochloride,timolol maleate

Available from:

Sandoz Pty Ltd

INN (International Name):

Dorzolamide hydrochloride,Timolol maleate

Authorization status:

Registered

Patient Information leaflet

DORZOLAMIDE/
TIMOLOL SANDOZ
®
20/5
_dorzolamide hydrochloride / timolol maleate eye drops_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DORZOLAMIDE/
TIMOLOL SANDOZ 20/5.
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 taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DORZOLAMIDE/
TIMOLOL SANDOZ
20/5 IS USED FOR
DORZOLAMIDE/TIMOLOL
SANDOZ 20/5 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. 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 DORZOLAMIDE/
TIMOLOL SANDOZ 20/5 helps
control your glaucoma

Summary of Product characteristics

_Product Information _
_ _
_Page 1 _
_Dorzolamide/Timolol Sandoz 20/5 eye drops _
_08/2017 _
_Sandoz Pty Ltd _
_ _
_Version 01 _
PRODUCT INFORMATION
DORZOLAMIDE/TIMOLOL SANDOZ
® 20/5 EYE DROPS
NAME OF THE MEDICINE
_ _
dorzolamide (as hydrochloride) and timolol (as maleate)
_Dorzolamide hydrochloride _
Chemical name:
(4
_S_
-
_trans_
)-4-(ethylamino)-5,6-dihydro-6-methyl-4
_H_
-thieno
[2,3-
_b_
]thiopyran-2-sulfonamide 7,7-dioxide
monohydrochloride.
Chemical structure :
CAS [130693-82-2]
Empirical formula:
C
10
H
17
N
2
O
4
S
3
Cl
MW:
360.91
_Timolol maleate _
Chemical name:
(S)-1-[(1,1-dimethylethyl)amino]-3-[[4-(4-morpholinyl)-
1,2,5-thiadiazol-3-yl]oxy]-2-propanol,(
_Z_
)-2-butenedioate
(1:1) (salt).
Chemical structure :
CAS [26921-17-5]
Empirical formula:
C
13
H
24
N
4
O
3
SC
4
H
4
O
4
MW:
432.50
_Product Information _
_ _
_Page 2 _
_Dorzolamide/Timolol Sandoz 20/5 eye drops _
_08/2017 _
_Sandoz Pty Ltd _
_ _
_Version 01 _
DESCRIPTION
_ _
Dorzolamide hydrochloride is a white to off-white, free flowing
crystalline powder,
which is soluble in water and slightly soluble in methanol and
ethanol.
Timolol maleate is a white, odourless, crystalline powder which is
soluble in water,
methanol, and alcohol.
_ _
Each millilitre of Dorzolamide/Timolol Sandoz 20/5 contains 20.00 mg
dorzolamide
(22.26 mg of dorzolamide hydrochloride) and 5.00 mg timolol (6.83 mg
of timolol
maleate) as the active ingredients. It also contains the following
inactive ingredients:
sodium citrate, hydroxyethylcellulose, sodium hydroxide, mannitol, and
water for
injections. Benzalkonium chloride (0.0075%) is added as preservative.
_ _
_ _
PHARMACOLOGY
_ _
Mechanism of action
Dorzolamide/Timolol Sandoz 20/5 is comprised of two components:
dorzolamide
hydrochloride and timolol maleate. It is the first combination of a
topical carbonic
anhydrase inhibitor and a topical beta-adrenergic receptor blocking
agent. Each of these
two components decreases elevated intraocular pressure by reducing
aqueous humor
secretion, but does so by a different mechanis