ESCITALOPRAM-LUPIN escitalopram (as oxalate) 20mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

escitalopram oxalate

Available from:

Lupin Australia Pty Limited

INN (International Name):

escitalopram oxalate

Authorization status:

Registered

Patient Information leaflet

1
ESCITALOPRAM-LUPIN TABLETS
Escitalopram oxalate
(Lupin Australia Pty. Ltd.)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet contains answers to some common questions about
Escitalopram-
Lupin Tablets.
It does not contain all the information that is known about
Escitalopram-Lupin
Tablets. It does not take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risk of you
using this medicine against the benefits he/she expects it will 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.
2
WHAT
ESCITALOPRAM-LUPIN
TABLETS
ARE
USED FOR
Escitalopram-Lupin Tablets are used to treat depression. It belongs to
a group of
medicines called selective serotonin reuptake inhibitors (SSRIs). They
are thought
to work by their actions on brain chemicals called amines which are
involved in
controlling mood.
Depression is longer lasting or more severe than the "low moods"
everyone has
from time to time due to the stress of everyday life. It is thought to
be caused by a
chemical imbalance in parts of the brain. This imbalance affects your
whole body
and can cause emotional and physical symptoms such as feeling low in
spirit, loss
of interest in activities, being unable to enjoy life, poor appetite
or overeating,
disturbed sleep, often waking up early, loss of sex drive, lack of
energy and feeling
guilty over nothing.
Escitalopram-Lupin Tablets correct this chemical imbalance and may
help relieve
the symptoms of depression.
Escitalopram-Lupin Tablets may also be used to treat patients who may
avoid
and/or are fearful of social situations.
Escitalopram-Lupin Tablets may also be used to treat patients who have
excessive
anxiety and worry.
Escitalopram-Lupin
Tablets
may
also
be
used
to
treat
irrational
fears
or
obsessional
behaviour
(obsessive-compulsive
disorder).
Obsessive-compulsive
disorder
involves
having
both
obsessions
and
compulsions.
Ob

Summary of Product characteristics

ESCITALOPRAM-LUPIN TABLETS
(LUPIN AUSTRALIA PTY. LTD)
NAME OF THE MEDICINE
Escitalopram-Lupin Tablets 5 mg containing
escitalopram (as oxalate) 5 mg,
Escitalopram-Lupin Tablets 10 mg containing
escitalopram (as oxalate) 10 mg,
Escitalopram-Lupin Tablets 15 mg containing
escitalopram (as oxalate) 15 mg and
Escitalopram-Lupin Tablets 20 mg containing
escitalopram (as oxalate) 20 mg
ESCITALOPRAM OXALATE
It
is
described
chemically
as
S
(+)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroiso
benzofuran-5-carbonitrile hydrogen oxalate. Escitalopram is the active
enantiomer (S-enantiomer)
of citalopram.
Molecular formula: C
20
H
21
FN
2
O, C
2
H
2
O
4
Molecular Weight: 414.42
CAS: 219861-08-2
Chemical structure:
DESCRIPTION
Escitalopram oxalate is a fine white to yellow, crystalline material.
Escitalopram oxalate is sparingly soluble in water, slightly soluble
in acetone, soluble in ethanol and
freely soluble in methanol. No polymorphic forms have been detected.
EXCIPIENTS
Microcrystalline
cellulose,
Croscarmellose
sodium,
,
Colloidal
silicon
dioxide,
Purified
talc,
Magnesium
stearate
and
Opadry White
Y-1-7000,
ARTG
no.
2731
(contains
Hypromellose,
Macrogol 400 and Titanium dioxide).
_Escitalopram-Lupin tablet _
_Product Information _
_Lupin Australia Pty Ltd _
Page 2 of 39
PHARMACOLOGY
PHARMACODYNAMICS: Biochemical and behavioural studies have shown that
escitalopram is a
potent inhibitor of serotonin (5-HT)-uptake (_in vitro _IC
50
2nM).
The anti-depressant action of escitalopram is presumably linked to the
potentiation of serotonergic
activity in the central nervous system (CNS) resulting from its
inhibitory effect on the reuptake of 5-
HT from the synaptic cleft.
Escitalopram is a highly selective Serotonin Reuptake Inhibitor
(SSRI). On the basis of _ in vitro _
studies, escitalopram had no, or minimal effect on noradrenaline (NA),
dopamine (DA) and gamma
aminobutyric acid (GABA) uptake.
In contrast to many tricyclic anti-depressants and some of the SSRIs,
escitalopram has no or very
low affinity for a serie