ESCITALOPRAM AN escitalopram (as oxalate) 10mg film-coated tablet blister pack

Summary of Product characteristics

                                _Escitalopram AN tablets Product Information _
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_Amneal Pharma Australia Pty Ltd _
ESCITALOPRAM AN
_(ESCITALOPRAM OXALATE TABLETS) _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is escitalopram oxalate
.
CHEMICAL NAME: _S-_
(
_+_
)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-
dihydroisobenzofuran-5-carbonitrile
hydrogen oxalate
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.
Escitalopram AN tablets 10 mg
_ _
are white to off white, oval, biconvex, film-coated tablets with
breakline on one side and plain on the other side having approximate
dimensions length about 8.0
mm and width about 5.5 mm.
Escitalopram AN tablets 20 mg
_ _
are white to off white, oval, biconvex, film-coated tablets with
breakline on one side and plain on the other side having approximate
dimensions, length about
11.5 mm and width about 7.0 mm.
Escitalopram AN tablets
_ _
also contain the following excipients: microcrystalline cellulose,
colloidal
anhydrous silica, purified talc, croscarmellose sodium, magnesium
stearate, hypromellose, macrogol
400 and titanium dioxide.
PHARMACOLOGY
Biochemical and behavioural studies have shown that escitalopram is a
potent inhibitor of serotonin
Escitalopram AN PI v3.0
Page 1
_Escitalopram AN tablets Product Information _
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_Amneal Pharma Australia Pty Ltd _
(5-HT)-uptake (
_in vitro _
IC
50
2nM). 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
                                
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