APO-Latanoprost/Timolol 0.05/5 Eye drops latanoprost 50 ug/mL and timolol (as maleate) 5 mg/mL bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

latanoprost, Quantity: 50 microgram/mL; timolol maleate, Quantity: 5 mg/mL

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Latanoprost,Timolol maleate

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: benzalkonium chloride; monobasic sodium phosphate monohydrate; water for injections; sodium hydroxide; dibasic sodium phosphate; hydrochloric acid; sodium chloride

Administration route:

Ophthalmic

Units in package:

2.5 mL (in 5 mL bottle)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. Latanoprost/Timolol eye drops should not be used to initiate therapy.

Product summary:

Visual Identification: Clear colourless solution, white translucent LDPE bottle, with white translucent LDPE dropper, light yellow opaque HDPE cap with sealing tape; Container Type: Bottle; Container Material: LDPE; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2014-04-08

Patient Information leaflet

APO- LATANOPROST/
TIMOLOL EYE DROPS
_Contains the active ingredients Latanoprost 50 mcg/mL and Timolol (as
maleate) 5 mg/mL_
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 latanoprost/timolol
eye drops. 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-
Latanoprost/Timolol eye drops. It
contains the active ingredients
latanoprost and timolol (as maleate).
It 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.
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 grad

Summary of Product characteristics

1
AUSTRALIAN PI –
APO-LATANOPROST/TIMOLOL 50/5 (LATANOPROST/TIMOLOL)
1
NAME OF THE MEDICINE
Latanoprost and Timolol maleate
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
The active ingredients in APO- Latanoprost/Timolol eye drops are
latanoprost and timolol maleate.
Latanoprost is a prostaglandin F2α analogue. It has a molecular
weight of 432.58. It is a colourless
to slightly yellow oil which is practically insoluble in water, freely
soluble in ethanol, ethyl acetate,
isopropanol, methanol, acetone and octanol, and very soluble in
acetonitrile.
Sixty four isomers of latanoprost are possible however, for
Latanoprost/Timolol eye drops it is
purified as a single isomer.
Timolol maleate is a beta-adrenergic receptor blocking agent. It has a
molecular weight of 432.50. It
is a white to off-white crystalline powder which is soluble in water,
alcohol and practically insoluble
in ether.
APO- Latanoprost/Timolol eye drops is a sterile, isotonic solution
containing 50 micrograms/mL of
latanoprost and 5mg/mL of timolol (6.83mg timolol maleate) in an
aqueous buffer solution of pH 6.0.
The excipients in the eye drops are sodium chloride, sodium
phosphate-monobasic dihydrate,
sodium phosphate- dibasic dodecahydrate, purified water and
benzalkonium chloride (0.20mg/mL)
as a preservative agent with sodium hydroxide or hydrochloric acid for
pH adjustment.
The solution is a clear and colourless liquid, filled in a
polyethylene container.
Each 5 mL bottle contains 2.5 mL of the eye drop solution
corresponding to a minimum of 80 drops
of solution. One drop contains approximately 1.5 µg latanoprost and
150 µg timolol.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open-angle
glaucoma and ocular
hypertension who are insufficiently responsive to beta-blockers,
prostaglandins or other intraocular
pressure lowering medications. Latanoprost/Timolol eye drops should
not be used to initiate therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
RECOMME