XALATAN Latanoprost 50 microgram/mL eye drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

latanoprost, Quantity: 50 microgram/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

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

Administration route:

Ophthalmic

Units in package:

1 x 2.5mL, 1 x 1mL, 6 x 2.5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are intolerant or insufficiently responsive to another intraocular pressure lowering medication. INDICATIONS AS AT 4 FEBRUARY 2003: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Product summary:

Visual Identification: clear, colourless liquid; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1997-07-23

Patient Information leaflet

XALATAN
1
XALATAN
_Latanoprost _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xalatan. 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 Xalatan against
the benefits it is expected to 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 XALATAN IS USED
FOR
Xalatan 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
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. If glaucoma is not treated
it can lead to serious problems,
including total blindness. In fact,
untreated glaucoma is one of the
most common causes of blindness.
_HOW XALATAN WORKS _
Xalatan belongs to a family of
medicines called prostaglandin
agonists.
It lowers the pressure in the eye by
allowing more fluid to flow out from
within your eye.
Although Xalatan helps control your
glaucoma it does not cure it. So you
must keep using it until your doctor
tells you to stop.
Xalatan is used, either alone or in
combination with other eye
medicines, to lower raised pressure
within your eye.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY

Summary of Product characteristics

Page 1 of 12
AUSTRALIAN
PRODUCT
INFORMATION
–[
XALATAN (LATANOPROST)]
1.
NAME OF THE MEDICINE
Latanoprost.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in XALATAN is latanoprost, a prostaglandin F
2
α
analogue.
XALATAN Eye Drops is a sterile, isotonic solution containing 50
micrograms/mL of
latanoprost in an aqueous buffer solution of pH 6.7.
Each 5 mL bottle contains 2.5 mL eye drop solution corresponding to a
minimum of 80 drops
of solution. One drop contains approximately 1.5 micrograms
latanoprost.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Eye Drops, solution
The solution is a clear and colourless liquid, filled in a
polyethylene container.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open-angle
glaucoma or ocular
hypertension.
4.2 DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE FOR ADULTS (INCLUDING THE ELDERLY)
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is
obtained if XALATAN is administered in the evening. Systemic
absorption can be minimised
by pressure on the tear duct immediately after application of the eye
drop.
If one dose is missed treatment should continue with the next dose as
normal.
The dosage of XALATAN should not exceed once daily since it has been
shown that more
frequent administration decreases the IOP lowering effect.
ADMINISTRATION
XALATAN is effective as a single drug therapy but can also be used in
combination with beta-
adrenergic antagonists (timolol), adrenergic agonists (dipivefrine
hydrochloride), cholinergic
Page 2 of 12
agonists (pilocarpine) and carbonic anhydrase inhibitors
(acetazolamide) to achieve an additive
effect. In case of combined therapy the eye drop products should be
administered with an
interval of at least five minutes.
Use with contact lenses: The contact lenses should be removed before
instillation of the eye
drops and may be reinserted after 15 minutes (see Section 4.4 Specia