CHEMMART ESCITALOPRAM escitalopram (as oxalate) 10 mg tablet blister
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
escitalopram oxalate
Available from:
Apotex Pty Ltd
INN (International Name):
escitalopram oxalate
Authorization status:
Registered
Patient Information leaflet
CHEMMART
ESCITALOPRAM
_Contains the active ingredient, escitalopram (as escitalopram
oxalate)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about escitalopram.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Escitalopram. It contains
the active ingredient, escitalopram
(as escitalopram oxalate).
It is used to treat
•
depression
•
obsessive-compulsive disorder.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Escitalopram belongs to a group of
medicines called Selective Serotonin
Reuptake Inhibitors (SSRIs).
Escitalopram and other SSRIs are
thought to help by increasing the
amount of serotonin in your brain.
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
i
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Summary of Product characteristics
Product Information – Australia
Chemmart Escitalopram Tablets
Page 1
CHEMMART ESCITALOPRAM TABLETS
NAME OF THE MEDICINE
Escitalopram oxalate.
Chemical Name:
_S_(+)-1-[3-(dimethylamino)propyl]-1-(4-flurophenyl)-1,3-dihydroisobenzofuran-
5-carbonitrile hydrogen oxalate
Structural Formula:
Molecular Formula:
C
20
H
21
FN
2
O.C
2
H
2
O
4
Molecular Weight:
414.42
CAS Registry Number:
219861-08-2
DESCRIPTION
Escitalopram is the active enantiomer (_S_-enantiomer) of citalopram.
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.
Each tablet contains 10 or 20 mg escitalopram (as oxalate). In
addition, each tablet contains the
following
inactive
ingredients:
microcrystalline
cellulose,
colloidal
anhydrous
silica,
purified
talc,
croscarmellose sodium, magnesium stearate, hypromellose, macrogol 400
and titanium dioxide.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Biochemical and behavioural studies have shown that escitalopram is a
potent inhibitor of serotonin
(5-HT)-uptake (_in vitro_ IC
50
2 nM).
The antidepressant 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 antidepressants and some of the SSRIs,
escitalopram has no or very low
affinity for a series of receptors including 5-HT
1A
, 5-HT
2
, DA D
1
and DA D
2
receptors,
1
-,
2
-,
β-adrenoceptors, histamine H
1
, muscarine cholinergic, benzodiazepine and opioid receptors. A series
of functional _in vitro_ tests in isolated organs as well as
functional _in vivo _tes
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