ESCIPRA 10 (ESCITALOPRAM TABLETS USP 10MG)

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

ESCITALOPRAM OXALATE

Tersedia dari:

SYNERRV SDN BHD

INN (Nama Internasional):

ESCITALOPRAM OXALATE

Unit dalam paket:

2 X 14 Tablets; 4 x 7 Tablets

Diproduksi oleh:

Macleods Pharmaceuticals Limited

Selebaran informasi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ESCIPRA 10 (ESCITALOPRAM TALETS USP 10MG)
Escitalopram 10mg (as Oxalate)
1
WHAT IS IN THIS LEAFLET
1.
What ESCIPRA 10 is used for
2.
How ESCIPRA 10 works
3.
Before you take ESCIPRA 10
4.
How to take ESCIPRA 10
5.
While you are using ESCIPRA 10
6.
Side Effects
7.
Storage and Disposal of ESCIPRA
10
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
1.
WHAT ESCIPRA 10 IS USED FOR
ESCIPRA 10 is used to treat depression
(major depressive episodes) and
anxiety disorders [such as panic
disorder with or without agoraphobia
(fear of leaving home, entering shops or
fear of being at open and public
places), social anxiety disorder (fear or
avoidance of social situations),
generalised anxiety disorder (generally
feeling anxious or nervous for no
reason) and obsessive- compulsive
disorder (persistent, obsessive thoughts
that make you carry out repetitive
behaviour)].
2.
HOW ESCIPRA 10 WORKS
ESCIPRA 10 belongs to a group of
antidepressants called selective
serotonin reuptake inhibitors (SSRIs).
These medicines act on the serotonin-
system in the brain by increasing the
serotonin level. Disturbances in the
serotonin-system are considered an
important factor in the development of
depression and related diseases.
3.
BEFORE YOU TAKE ESCIPRA 10
_When you must not take it _
Do not take:
□
if you are allergic (hypersensitive)
to
escitalopram
or
any
of
the
other
ingredients of ESCIPRA 10
□
If
you
take
other
medicines
that
belong to a group called monoamine
oxidase
(MAO)
inhibitors,
including
selegiline
(used
in
the
treatment
of
Parkinson´s
disease),
moclobemide
(used in the treatment of depression)
and
linezolid
(an
antibiotic).
Taking
ESCIPRA 10 with MAO inhibitors
may cause serious and sometimes fatal
reactions
with
features
resembling
serotonin syndrome such as high fever,
agitation,
confusion,
trembling
and
abrupt contractions of muscles. If you
feel like this, contact your doctor.
□
If you are born with or have had an
episode of abn

Karakteristik produk

SECTION D ARTWORKS
ESCIPRA 10
ESCITALOPRAM TABLETS USP 10 MG MACLEODS PHARMACEUTICALS LTD.
D3 PACKAGE INSERT
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A LABORATORY
ESCIPRA 10
(ESCITALOPRAM TABLETS USP 10 MG)
COMPOSITION
Each film coated tablet contains:
Escitalopram Oxalate USP
Equivalent to Escitalopram ……10 mg
DESCRIPTION
Escitalopram oxalate is
an
orally
administered
selective
serotonin
reuptake
inhibitor
(SSRI).
Chemically,
Escitalopram
oxalate
is
described
as
S-(+)-1-[3-(dimethyl-amino)propyl]-1-(
_p_
-
fluorophenyl)-5-phthalancarbonitrile oxalate. Its molecular formula is
C
20
H
21
FN
2
O • C
2
H
2
O
4
, and
molecular weight is 414.40.
PRODUCT DESCRIPTION
White to off-white, circular, biconvex, film coated tablet having ML
60 debossed on one side, break-
line on opposite side and having notches on either ends of break line.
PHARMACOLOGICAL CLASSIFICATION
Antidepressants, selective serotonin reuptake inhibitors
PHARMACOLOGICAL ACTION:
ATC CODE:
N 06 AB 10
PHARMACOKINETICS
Absorption
Absorption is almost complete and independent of food intake. (Mean
time to maximum concentration
(mean T
max
) is 4 hours after multiple dosing).
As with racemic citalopram, the absolute bioavailability of
escitalopram is expected to be about 80%.
SECTION D ARTWORKS
ESCIPRA 10
ESCITALOPRAM TABLETS USP 10 MG MACLEODS PHARMACEUTICALS LTD.
Distribution
The apparent volume of distribution (V
d,β
/F) after oral administration is about 12 to 26 L/kg. The
plasma protein binding is below 80% for escitalopram and its main
metabolites.
Biotransformation
Escitalopram is metabolised in the liver to the demethylated and
didemethylated metabolites. Both of
these are pharmacologically active. Alternatively, the nitrogen may be
oxidised to form the N-oxide
metabolite. Both parent substance and metabolites are partly excreted
as glucuronides. After multiple
dosing the mean concentrations of the demethyl and didemethyl
metabolites are usually 28-31% and
<5%,
respectively,
of
the
escitalopram
concentration.
Biot