OLODIN Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% wv

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

OLOPATADINE HYDROCHLORIDE

Dostępny od:

UNIMED SDN BHD

INN (International Nazwa):

OLOPATADINE HYDROCHLORIDE

Sztuk w opakowaniu:

5 ml; 5ml mL

Wyprodukowano przez:

FDC LIMITED

Ulotka dla pacjenta

OLODIN
(Olopatadine HCL Opthalmic Solution USP 0.1% w/v)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What OLODIN is used for
How OLODIN works
2.
Before you use OLODIN
3.
How to use OLODIN
4.
While you are using it
5.
Side effects
6.
Storage and Disposal of OLODIN
7.
Product Description
8.
Manufacturer
and
Product
Registration Holder
9.
Date of revision
WHAT OLODIN IS USED FOR
OLODIN is used for the treatment of
signs and symptoms of seasonal allergic
conjunctivitis.
Allergic conjunctivitis. Some materials
(Allergens) like pollens, house dust or
animal fur may cause allergic reactions
resulting in itching, redness as well as
swelling of the surface of your eye.
OLODIN is a medicine for treatment of
allergic conditions of the eye.
HOW OLODIN WORKS
It works by reducing the intensity of the
allergic reaction.
BEFORE YOU USE OLODIN
-
_When you must not use it_
_Pregnancy and lactation _
Do
not
take
OLODIN
_ _
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take OLODIN
_ _
if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start use it_
Talk to your doctor or pharmacist before
using OLODIN.
You should remove contact lenses that
are in your eyes before using OLODIN.
Children
• Do not use OLODIN in children under
the
age
of
3
years.
Do
not
give
this
medicine to children under the ages of 3
years because there is no data to indicate
that it is safe and work in children under
3 years.
-
_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.
If you are using other eye drops or eye
ointment medicines, leave at least 5
minutes between each medicine. Eye
ointments should be administered last.
HOW TO USE
OLODIN
-
_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 d

Charakterystyka produktu

OLODIN
(OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP 0.1% W/V)
DESCRIPTION
Clear, colourless solution
COMPOSITION
Olopatadine hydrochloride USP equivalent to Olopatadine….. 1.0mg
Benzalkonium Chloride NF (as Preservative) … 0.1mg
Sterile Aqueous Vehicle …..q.s
PHARMACODYNAMICS
Olopatadine is a potent selective antiallergic /antihistaminic agent
that exerts its effects
through multiple distinct mechanism 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. Data from
in vitro studies suggest
that 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 sign and symptoms that
frequently accompany
seasonal allergic conjunctivitis. It does not produce a clinically
significant change in pupil
diameter.
PHARMACOKINETICS
Absorption
Olopatadine ophthalmic solution is absorbed systemically, as are other
topically administered
medicinal products. However, systemic absorption of topically applied
olopatadine is
minimal with plasma concentration ranging from below the assay
quantitation limit (<
0.5ng/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 concentration 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