APO-DORZOLAMIDE/TIMOLOL 20/5 dorzolamide/timolol eye drops

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dorzolamide hydrochloride,timolol maleate

Available from:

Apotex Pty Ltd

INN (International Name):

Dorzolamide hydrochloride,Timolol maleate

Authorization status:

Registered

Patient Information leaflet

APO-DORZOLAMIDE/
TIMOLOL
_Contains the active dorzolamide (as hydrochloride) 2.0% and timolol
(as maleate) 0.5%_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about dorzolamide/timolol.
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
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Dorzolamide/Timolol eye drops. It
contains the active ingredients
dorzolamide (22.3 mg of
dorzolamide hydrochloride) and
timolol (6.8 mg of timolol maleate).
It is used to treat 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 r

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- DORZOLAMIDE/TIMOLOL
20/5 DORZOLAMIDE (AS HYDROCHLORIDE) AND TIMOLOL
(AS MALEATE) EYE DROPS, SOLUTION
1
NAME OF THE MEDICINE
Dorzolamide hydrochloride and Timolol maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of dorzolamide/timolol combination eye drops contains
20.0 mg (2% w/v)
dorzolamide (22.3 mg of dorzolamide hydrochloride) and 5.0 mg (0.5%
w/v) timolol (6.8 mg of
timolol maleate) as the active ingredients.
It is a sterile, isotonic, buffered, slightly viscous, aqueous
solution.
List of excipient(s) with known effect: benzalkonium chloride.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to nearly colourless, slightly viscous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dorzolamide/timolol combination eye drops is indicated in the
treatment of elevated intraocular
pressure (IOP) in patients with ocular hypertension or open-angle
glaucoma when concomitant
therapy is appropriate.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Dorzolamide/Timolol 20/5 Eye Drops are intended for ophthalmic
administration and for
individual patient use only.
DOSAGE
The dose is one drop of dorzolamide/timolol combination (2.0%/0.5%)
eye drops in the affected
eye(s) two times daily.
When
substituting
dorzolamide/timolol
combination
eye
drops
for
another
ophthalmic
antiglaucoma agent(s), discontinue the other agent(s) after proper
dosing on one day, and
start dorzolamide/timolol combination eye drops on the next day.
If another topical ophthalmic agent is being used, dorzolamide/timolol
combination eye drops
and the other agent should be administered at least ten minutes apart.
Systemic absorption can be minimised by pressure on the tear duct
immediately after
application of the eye drop.
Efficacy in paediatric patients has not been established. Safety in
paediatric patients below the
age of 2 years has not been established (For information regarding
safety in paediatric patients
2
≥