TRUSAMIDE dorzolamide (as hydrochloride) 20 mg/mL eye drops bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
08-04-2022
Summary of Product characteristics
(SPC)
08-04-2022
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
dorzolamide hydrochloride, Quantity: 22.26 mg/mL (Equivalent: dorzolamide, Qty 20 mg/mL)
Available from:
Viatris Pty Ltd
INN (International Name):
Dorzolamide hydrochloride
Pharmaceutical form:
Eye Drops
Composition:
Excipient Ingredients: water for injections; benzalkonium chloride; hyetellose; mannitol; sodium citrate dihydrate; sodium hydroxide
Administration route:
Ophthalmic
Units in package:
1 X 5 mL
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
TRUSAMIDE Eye Drops are indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Product summary:
Visual Identification: Clear, slightly viscous, colorless aqueous solution; Container Type: Bottle; Container Material: PE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-09-25
Patient Information leaflet
TRUSAMIDE
_Dorzolamide hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TRUSAMIDE. 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 TRUSAMIDE
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 TRUSAMIDE IS
USED FOR
TRUSAMIDE 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 TRUSAMIDE 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 1800 500 880.
TRUSAMIDE is u
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Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION
TRUSAMIDE
_(dorzolamide hydrochloride) eye drops _
1
NAME OF THE MEDICINE
Dorzolamide hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of TRUSAMIDE contains 20 mg (2%) dorzolamide (22.3 mg of
dorzolamide hydrochloride).
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, slightly viscous, colourless aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TRUSAMIDE eye drops are indicated in the treatment of elevated
intraocular pressure in patients with ocular
hypertension or open-angle glaucoma.
4.2
DOSE AND METHOD OF ADMINISTRATION
For individual patient use only.
When used as monotherapy, the dose is one drop of TRUSAMIDE in the
affected eye(s) three times
daily.
When used as adjunctive therapy with an ophthalmic beta-blocker, the
dose is one drop of TRUSAMIDE
in the affected eye(s) two times daily.
When substituting TRUSAMIDE for another ophthalmic antiglaucoma
agent, discontinue the other agent
after usual dosing on one day, and start TRUSAMIDE 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.
4.3
CONTRAINDICATIONS
TRUSAMIDE is contraindicated in patients who are hypersensitive to any
component of this product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL
The management of patients with acute angle-closure glaucoma requires
therapeutic interventions in addition
to ocular hypotensive agents. Dorzolamide hydrochloride eye drops has
not been studied in patients with acute
angle-closure glaucoma.
Dorzolamide hydrochloride eye drops is a sulphonamide and although
administered topically, is absorbed
systemically. Therefore the same types of adverse reactions that are
attributable to sulphonamides may occur
TRUSAMIDE – PRODUCT INFORMATION
2
with topical administration,
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