TRUSOPT dorzolamide 20mg/mL (as hydrochloride) eye drops bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

dorzolamide hydrochloride, Quantity: 22.26 mg/mL (Equivalent: dorzolamide, Qty 20 mg/mL)

Tilgjengelig fra:

Mundipharma Pty Ltd

Legemiddelform:

Eye Drops, solution

Sammensetning:

Excipient Ingredients: mannitol; sodium citrate dihydrate; benzalkonium chloride; hyetellose; water for injections; sodium hydroxide

Administreringsrute:

Ophthalmic

Enheter i pakken:

5mL

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Trusopt eye drops are indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open- angle glaucoma.

Produkt oppsummering:

Visual Identification: Clear, colourless to nearly colourless, slightly viscous solution, practically free from particles.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

1996-04-18

Informasjon til brukeren

TRUSOPT
®
EYE DROPS
1
TRUSOPT
®
Dorzolamide hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about TRUSOPT. 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 TRUSOPT
against the benefits they expect it
will 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 TRUSOPT is
used for
TRUSOPT 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 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 TRUSOPT helps control
your glaucoma it does not cure it.
For more information about
glaucoma, contact Glaucoma
Australia Inc., PO Box 420, Crows
Nest 1585, telephone [phone].
TR

Preparatomtale

TRUSOPT® EYE DROPS
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION – TRUSOPT
®
(DORZOLAMIDE
(AS HYDROCHLORIDE)) EYE DROPS
1
NAME OF THE MEDICINE
Dorzolamide hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of TRUSOPT contains 20 mg (2%) dorzolamide (22.3 mg of
dorzolamide
hydrochloride).
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, sterile,
isotonic, buffered solution,
practically free from particles.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TRUSOPT eye drops are indicated in the treatment of elevated
intraocular pressure in patients
with ocular hypertension or open-angle glaucoma.
4.2
D
OSE AND METHOD OF ADMINISTRATION
When used as monotherapy, the dose is one drop of TRUSOPT in the
affected eye(s) three times
daily.
When used as adjunctive therapy with an ophthalmic beta-blocker, the
dose is one drop of
TRUSOPT in the affected eye(s) two times daily.
When substituting TRUSOPT for another ophthalmic antiglaucoma agent,
discontinue the other
agent after usual dosing on one day, and start TRUSOPT on the next
day.
If more than one topical ophthalmic drug is being used, the drugs
should be administered at
least ten minutes apart.
Systemic absorption of drugs from ophthalmic solutions may be
minimised by pressure on the
tear-duct immediately after application.
TRUSOPT® EYE DROPS
Page 2 of 9
4.3
C
ONTRAINDICATIONS
TRUSOPT is contraindicated in patients who are hypersensitive to any
component of this
product.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
General
The management of patients with acute angle-closure glaucoma requires
therapeutic
interventions in addition to ocular hypotensive agents. TRUSOPT has
not been studied in
patients with acute angle-closure glaucoma.
TRUSOPT is a sulphonamide and although administered topically, is
absorbed systemically.
Therefore, the same types of adverse reactions th