Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
escitalopram oxalate
Amneal Pharma Australia Pty Ltd
escitalopram oxalate
Registered
_Escitalopram AN tablets Product Information _ _ _ _ _ _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 _ _ _ _ _ _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 Læs hele dokumentet