TIMOLOL MLabs 0.25% timolol (as maleate) 2.5 mg/ mL eye drops solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

timolol maleate, Quantity: 3.4 mg/mL (Equivalent: timolol, Qty 2.5 mg/mL)

Available from:

Micro Labs Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: sodium hydroxide; dibasic sodium phosphate dodecahydrate; benzalkonium chloride; water for injections; monobasic sodium phosphate dihydrate

Administration route:

Ophthalmic

Units in package:

5 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Timolol ophthalmic solution is indicated for the reduction of elevated intraocular pressure.,In clinical trials it has been shown to reduce intraocular pressure in:,Patients with ocular hypertension,Patients with chronic open-angle glaucoma,Aphakic patients with glaucoma.

Product summary:

Visual Identification: Clear colorless to pale yellow liquid, practically free from visible particles.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-07-03

Patient Information leaflet

TIMOLOL
MLABS
0.25% AND 0.5% EYE DROPS SOLUTION
_TIMOLOL MALEATE_
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak
to your doctor or pharmacist.
1.
WHY AM I USING TIMOLOL MLABS?
TIMOLOL MLabs 0.25% contains 3.4 mg of timolol maleate as Timolol.
TIMOLOL MLabs 0.5% contains 6.8 mg of timolol maleate as Timolol.
TIMOLOL MLabs is used to lower raised pressure in the eye and to treat
glaucoma.
For more information, see Section 1. Why am I using TIMOLOL MLabs? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TIMOLOL MLABS?
Do not use if you have ever had an allergic reaction to TIMOLOL MLabs
or any of the ingredients
listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE
PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
TIMOLOL MLabs? in the
full CMI.
3. WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TIMOLOL MLabs and affect how it
works.
A list of these medicines is in Section 3.What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TIMOLOL MLABS?
Your doctor will tell you how many drops to take each day. The usual
dose for adults is one drop of
TIMOLOL MLabs twice a day, in either one or both eyes.
More instructions can be found in Section 4. How do I use TIMOLOL
MLabs? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TIMOLOL MLABS?
THINGS YOU SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
TIMOLOL MLabs
THINGS
YOU
SHOULD
NOT DO

Do not give TIMOLOL MLabs to anyone else, even if they have the
same condition as you.

Do not stop using TIMOLOL MLabs without first talking to your
doctor.
DRIVING
OR
USING
MACHINES
Be careful driving or operating machinery until you know how
TIMOLOL MLabs affects you.
LOOKING
AFTER
YOUR
Keep your eye drops in a cool place where the temperature stays below
MEDICINE
30ºC.

Summary of Product characteristics

PRODUCT INFORMATION
TIMOLOL MLABS 0.25% AND 0.5% EYE DROPS SOLUTION
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Timolol maleate
CAS NUMBER:
26921-17-5
CHEMICAL STRUCTURE
Timolol maleate is described chemically as
(S)-1-((1,1-dimethylethyl)amino)-3-((4-(4-
morpholinyl) -1,2,5-thiadiazol-3-yl)oxy)-2-propanol,
(Z)-butenedioate(1:1)salt. Timolol
maleate possesses an asymmetric carbon atom in its structure and is
provided as the levo
isomer. The empirical formula is C
13
H
24
N
4
O
3
S.C
4
H
4
O
4
and the structural formula is:
DESCRIPTION
Timolol maleate has a molecular weight of 432.50. It is a white or
almost white,
crystalline
powder
or
colourless
crystals
which
is
soluble
in
water,
and
ethanol(96%). Timolol MLabs is stable at room temperature
Timolol MLabs eye drops is clear colorless to pale yellow liquid,
practically free from visible
particles. The inactive ingredients are: benzalkonium chloride as
preservative agent, monobasic
sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate,
sodium hydroxide for
pH adjustment, water for injections.
PHARMACOLOGY
Timolol maleate is a non-selective beta-adrenergic receptor blocking
agent that does not
have
significant
intrinsic
sympathomimetic,
direct
myocardial
depressant,
or
local
anaesthetic (membrane-stabilising) activity. Timolol maleate combines
reversibly with a part
of the cell membrane, the beta-adrenergic receptor, and thus inhibits
the usual biological
response that
would
occur
with
stimulation
of
that
receptor.
This
specific competitive
antagonism blocks stimulation of the beta-adrenergic receptors by
catecholamines having
beta-adrenergic stimulating (agonist) activity, whether these
originate from an endogenous
or exogenous source. Reversal of this blockade can be accomplished by
increasing the
concentration of the agonist, which will restore the usual biological
response.
Ophthalmic
Solution timolol (timolol
maleate)
reduces
elevated
and
normal
intraocular
pressure whether or not associated with glaucoma. Elevated intraocular
pressure is a majo