COSOPT dorzolamide hydrochloride 20mg and timolol maleate 5mg per mL eye drop bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

timolol maleate, Quantity: 6.83 mg/mL (Equivalent: timolol, Qty 5 mg/mL); 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: benzalkonium chloride; mannitol; sodium hydroxide; water for injections; hyetellose; sodium citrate dihydrate

Administreringsrute:

Ophthalmic

Enheter i pakken:

5mL

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Cosopt is indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma when concominant therapy is appropriate.

Produkt oppsummering:

Visual Identification: Clear, colourless to nearly colourless, slightly viscous solution.; 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:

1999-09-02

Informasjon til brukeren

COSOPT
®
1
COSOPT
®
Dorzolamide hydrochloride/Timolol maleate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about COSOPT. 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 COSOPT
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 COSOPT is used
for
COSOPT 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 COSOPT 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]

Preparatomtale

COSOPT® EYE DROPS
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION – COSOPT

[DORZOLAMIDE
(AS HYROCHLORIDE) AND TIMOLOL (AS MALEATE)] EYE DROPS
1
NAME OF THE MEDICINE
Dorzolamide hydrochloride and timolol maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
COSOPT is supplied as a sterile, isotonic, buffered, slightly viscous,
aqueous solution. Each
millilitre of COSOPT contains 20.00 mg (2.0% w/v) dorzolamide (22.26
mg of dorzolamide
hydrochloride) and 5.00 mg (0.5% w/v) timolol (6.83 mg of timolol
maleate) as the active
ingredients.
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
T
HERAPEUTIC INDICATIONS
COSOPT 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
D
OSE AND METHOD OF ADMINISTRATION
The dose is one drop of COSOPT in the affected eye(s) two times daily.
When substituting COSOPT for another ophthalmic antiglaucoma agent(s),
discontinue the
other agent(s) after proper dosing on one day, and start COSOPT on the
next day.
If another topical ophthalmic agent is being used, COSOPT and the
other agent should be
administered at least ten minutes apart.
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 and <6 years of age, see Section 4.4 Special Warnings and
Precautions for Use/Paediatric
Use).
COSOPT® EYE DROPS
Page 2 of 14
4.3
C
ONTRAINDICATIONS
COSOPT is contraindicated in patients with:

reactive airway disease, bronchial asthma or a history of bronchial
asthma, or severe chronic
obstructive pulmonary disease

sinus bradycardia, sino-atrial block, second or third degree
atrioventricular block, overt
cardiac failu