资料单张
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ESCITALUPIN TABLETS
Escitalopram oxalate
(Lupin Australia Pty. Ltd.)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet contains answers to some common questions about Escitalupin
Tablets.
It does not contain all the information that is known about Escitalupin 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.
WHAT ESCITALUPIN TABLETS ARE USED FOR
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Escitalupin 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.
Escitalupin Tablets correct this chemical imbalance and may help r
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产品特点
ESCITALUPIN TABLETS
(LUPIN AUSTRALIA PTY. LTD)
NAME OF THE MEDICINE
Escitalupin Tablets 5 mg
containing escitalopram (as oxalate) 5 mg,
Escitalupin Tablets 10 mg containing escitalopram (as oxalate) 10 mg,
Escitalupin Tablets 15 mg
containing escitalopram (as oxalate) 15 mg and
Escitalupin 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).
_Escitalupin 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
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