RELESTAT (EPINASTINE HYDROCHLORIDE OPTHALMIC SOLUTION) 0.5mgml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EPINASTINE HCL

Boleh didapati daripada:

ABBVIE SDN BHD

INN (Nama Antarabangsa):

EPINASTINE HCL

Unit dalam pakej:

5 ml

Dikeluarkan oleh:

ALLERGAN PHARMACEUTICALS IRELAND

Risalah maklumat

RELESTAT™ OPHTHALMIC SOLUTION
epinastine hydrochloride (0.5 mg/mL)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
RELESTAT™
is used for
2.
How
RELESTAT™
works
3.
Before you use
RELESTAT™
4.
How to use
RELESTAT™
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
RELESTAT™
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT RELESTAT™ IS USED FOR
RELESTAT™
is
an
anti-allergic
medicine.
It
is
an
eye
drops
solution
used
to
prevent itching associated with allergic
disease affecting the eye.
HOW RELESTAT™ WORKS
RELESTAT™
blocks
the
release
of
histamine from certain cells and works
locally in the eye.
BEFORE YOU USE RELESTAT™
-
_When you must not use it_
_ _
_ _
-
If you are allergic (hypersensitive)
to:
epinastine
hydrochloride
or
any
of
the
other
ingredients
of
RELESTAT™
listed in Section
“Product Description”.
-
_Pregnancy and breast-feeding:_
-
If you are pregnant or if you think
you
may
be
pregnant,
ask
your
doctor
or
pharmacist
for
advice
before using
RELESTAT™
.
-
Breast-feeding:
It
is
not
known
whether
RELESTAT™
passes
into breast milk. Ask your doctor
or
pharmacist
for
advice
before
using
RELESTAT™
during
breast-feeding.
_ _
_ _
-
_Before you start use it _
Take
special
care
with
RELESTAT™
.
RELESTAT™
contains
a
preservative,
called
benzalkonium
chloride that can discolour soft contact
lenses and may cause eye irritation.
If you wear soft contact lenses: you
must
remove
them
before
using
the
RELESTAT™
eye drops.
After
using
RELESTAT™
,
wait
at
least 10 minutes before putting your
lenses back in.
_ _
-
_Taking other medicine _
_ _
Please tell your doctor or pharmacist if
you are using or have recently used
any
other
medicines,
including
medicines
obtained
without
a
prescription.
If you have to use any other eye drops
during treatment with
RELESTAT™
:
leave
at
least
10
minutes
between
putting
in
RELESTAT™
and
the
other drops.
HOW TO USE RELESTAT™
-
_How much to use _
A

Ciri produk

RELESTAT™
(EPINASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION) 0.5 MG/ML
Sterile
RELESTAT™
(epinastine HCl ophthalmic solution) 0.05% is a clear, colorless,
sterile isotonic
solution containing epinastine HCl, an antihistamine and an inhibitor
of histamine release from
the mast cell for topical administration to the eyes.
Epinastine HCl is represented by the following structural formula:
C
16
H
15
N
3
HCl Mol. Wt. 285.78
CHEMICAL NAME:
3-Amino-9, 13b-dihydro-1H-dibenz[c,f] imidazo[1,5-a] azepine
hydrochloride
EACH ML CONTAINS:
Active: Epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine
0.044%
(0.44 mg/mL);
PRESERVATIVE:
Benzalkonium chloride 0.01%;
INACTIVES:
Edetate disodium; purified water; sodium chloride; sodium phosphate,
monobasic;
sodium hydroxide and 1N sodium hydroxide and/or 1N hydrochloric acid
(to adjust the pH).
RELESTAT™
has a pH of approximately 7 and an osmolality range of 250 to 310
mOsm/kg.
CLINICAL PHARMACOLOGY
Epinastine is a topically active, direct H
1
-receptor antagonist and an inhibitor of the release of
histamine from the mast cell. Epinastine is selective for the
histamine H
1
-receptor and has
affinity for the histamine H
2
-receptor. Epinastine also possesses affinity for the ∂
1
-, ∂
2
-, and 5-
HT
2
-receptors. Epinastine does not penetrate the blood/brain barrier and,
therefore, is not
expected to induce side effects of the central nervous system.
Fourteen subjects, with allergic conjunctivitis, received one drop of
RELESTAT™
ophthalmic
solution in each eye twice daily for seven days. On day seven average
maximum epinastine
plasma concentrations of 0.04 ±0.014 ng/ml were reached after about
two hours indicating low
systemic exposure. While these concentrations represented an increase
over those seen following
a single dose, the day 1 and day 7 Area Under the Curve (AUC) values
were unchanged
indicating that there is no increase in systemic absorption with
multiple dosing. Epinastine is
64% bound to plasma proteins. The total systemic clearance is
approximately 56 L/hr