ESCITALOPRAM-LAPL escitalopram (as oxalate) 10mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

escitalopram oxalate, Quantity: 12.77 mg (Equivalent: escitalopram, Qty 10 mg)

Available from:

Lupin Australia Pty Limited

INN (International Name):

escitalopram oxalate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: purified talc; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

200 tablets, 100 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

- Treatment of major depression. - Treatment of social anxiety disorder (social phobia). - Treatment of generalised anxiety disorder. - Treatment of obsessive-compulsive disorder.

Product summary:

Visual Identification: White to off-white, round, film coated tablets debossed with "10" on one side and scored on the other side which contain escitalopram (as oxalate) 10mg.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2011-03-23

Patient Information leaflet

1
ESCITALOPRAM-LAPL 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-
LAPL Tablets.
It does not contain all the information that is known about
Escitalopram-LAPL
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-LAPL
TABLETS
ARE
USED FOR
Escitalopram-LAPL 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-LAPL Tablets correct this chemical imbalance and may help
relieve
the symptoms of depression.
Escitalopram-LAPL Tablets may also be used to treat patients who may
avoid
and/or are fearful of social situations.
Escitalopram-LAPL Tablets may also be used to treat patients who have
excessive
anxiety and worry.
Escitalopram-LAPL
Tablets
may
also
be
used
to
treat
irrational
fears
or
obsessional
behaviour
(obsessive-compulsive
disorder).
Obsessive-compulsive
disorder
involves
having
both
obsessions
and
compulsions.
Obsessions

Summary of Product characteristics

ESCITALOPRAM-LAPL TABLETS
(LUPIN AUSTRALIA PTY. LTD)
NAME OF THE MEDICINE
Escitalopram-LAPL Tablets 5 mg containing
escitalopram (as oxalate) 5 mg,
Escitalopram-LAPL Tablets 10 mg containing
escitalopram (as oxalate) 10 mg,
Escitalopram-LAPL Tablets 15 mg containing
escitalopram (as oxalate) 15 mg and
Escitalopram-LAPL 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-LAPL 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 series of r