Olopan 0.1%wv Eye Drops

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

OLOPATADINE HYDROCHLORIDE

Boleh didapati daripada:

Vitamode Sdn.bhd

INN (Nama Antarabangsa):

OLOPATADINE HYDROCHLORIDE

Unit dalam pakej:

5 ml

Dikeluarkan oleh:

BEXIMCO PHARMACEUTICAL LTD

Risalah maklumat

OLOPAN 0.1%W/V EYE DROPS
Olopatadine 1 mg/mL
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Olopan Eye Drops is used for
2.
How Olopan Eye Drops works
3.
Before you use Olopan Eye Drops
4.
How to use Olopan Eye Drops
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Olopan Eye
Drops
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT OLOPAN EYE DROPS
IS USED FOR
Olopan is used for the treatment of signs
and symptoms of allergic conjunctivitis.
HOW OLOPAN EYE DROPS
WORKS
Olopan is a medicine for treatment of
allergic conditions of the eye. It works
by reducing the intensity of the allergic
reaction.
BEFORE
YOU
USE
OLOPAN
EYE
DROPS
_When you must not use it _
Do not use Olopan Eye drops when you
are allergic to olopatadine or any of the
other ingredients of this medicine.
Do not use if you are under 3 year old.
_ _
_Pregnancy and lactation _
Do not take Olopan Eye drops if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Olopan Eye drops if you are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
_ _
-
_Before you start to use it _
Remove your contact lenses before using
Olopan Eye drops and wait at least 15
minutes before putting your lenses back
in.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy,
supermarket
or
health
food
shop.
HOW TO USE OLOPAN EYE DROPS
-
_How much to use _
Follow all directions given
to you by
your
doctor
and
pharmacist
carefully.
They may differ from the information
contained in this leaflet. If you do not
understand the instructions on the label,
ask your doctor or pharmacist for help.
One drops of Olopan Eye drops to be
used on affected eye(s) two times daily.
-
_For proper application of the Olopan _
_Eye Drops, following steps should be _
_taken: _
1.
Wash your hand before using.
2.
Twist off the cap of the bottle.
3.

Ciri produk

OLOPAN
®
0.1%W/V EYE DROPS
Olopatadine 1mg/ml
PRODUCT DESCRIPTION
Colorless, clear solution.
PHARMACODYNAMICS
Olopatadine is a potent selective antiallergic/antihistaminic agent
that exerts its effects through
multiple distinct mechanisms of action. It antagonises histamine (the
primary mediator of allergic
response in humans) and prevents histamine induced inflammatory
cytokine production by human
conjunctival epithelial cells. It may act on human conjunctival mast
cells to inhibit the release of pro-
inflammatory mediators. In patients with patent nasolacrimal ducts,
topical ocular administration of
Olopatadine was suggested to reduce the nasal signs and symptoms that
frequently accompany
seasonal allergic conjunctivitis. It does not produce a clinically
significant change in pupil diameter.
PHARMACOKINETICS
Absorption
Olopatadine is absorbed systemically, as are other topically
administered medicinal products.
However, systemic absorption of topically applied olopatadine is
minimal with plasma concentrations
ranging from below the assay quantitation limit (<0.5 ng/ml) up to 1.3
ng/ml. These concentrations
are 50-to 200-fold lower than those following well tolerated oral
doses.
Elimination
From oral pharmacokinetic studies, the half-life of olopatadine in
plasma was approximately eight to
12 hours, and elimination was predominantly through renal excretion.
Approximately 60-70% of the
dose was recovered in the urine as active substance. Two metabolites,
the mono-desmethyl and the N-
oxide, were detected at low concentrations in the urine.
Since olopatadine is excreted in urine primarily as unchanged active
substance, impairment of renal
function alters the pharmacokinetics of olopatadine with peak plasma
concentrations 2.3-fold greater
in patients with severe renal impairment (mean creatinine clearance of
13.0 ml/min) compared to
healthy adults. Following a 10 mg oral dose in patients undergoing
haemodialysis (with no urinary
output), plasma olopatadine concentrations were significantly lower on
the haemodialys