Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
MAPROTILINE HYDROCHLORIDE
TEVA CANADA LIMITED
N06AA21
MAPROTILINE
50MG
TABLET
MAPROTILINE HYDROCHLORIDE 50MG
ORAL
(BTLS)100&500,(BX)100U DS
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0111022004; AHFS:
CANCELLED POST MARKET
2018-04-30
PRODUCT MONOGRAPH PR TEVA-MAPROTILINE (Maprotiline Hydrochloride) 25, 50 and 75 mg Tablets USP Antidepressant Teva Canada Limited Date of Preparation: 30 Novopharm Court September 19, 2011 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Submission Control#: 149911 2 PRODUCT MONOGRAPH TEVA-MAPROTILINE (Maprotiline Hydrochloride) 25, 50 and 75 mg Tablets USP THERAPEUTIC CLASSIFICATION Antidepressant ACTION AND CLINlCAl PHARMACOLOGY TEVA-MAPROTILINE (maprotiline hydrochloride) has been shown to exhibit an antidepressant action. Noradrenaline in the brain and peripheral tissues is strongly inhibited by maprotiline, though it is ,notable in its lack of inhibition of serotonergic uptake. It has markedly less pronounced alpha adrenergic blocking activity than amitriptyline. In the pharmacologic profile of maprotiline, a strong antihistaminic and a weaker anticholinergic action are seen. Maprotiline also exerts a sedative effect on the anxiety component of depressive illness. It is postulated that maprotiline exerts its antidepressant action by inhibition of presynaptic uptake of catecholamines, thereby increasing their concentration at the synaptic clefts of the brain. The effect of maprotiline on the EEG in single doses revealed a rise in the alpha-wave density, a reduction of the alpha-wave frequency and an increase in the alpha-wave amplitude. However, maprotiline, as with other tricyclic antidepressants lowers the convulsive threshold. In one as 3 yet uncorroborated "sleep study", it appears that maprotiline increases the REM phase of sleep in depressed patients, from its initially reduced base line, whereas imipramine reduced the REM phase of sleep. Maprotiline is completely absorbed after oral administration in man. The binding to serum proteins was found to be 88%. In man, the half-life of unchanged maprotiline is relatively long and ranged from 27.4 to 57.6 hours. Following repeated daily doses of maprotiline, a plasma steady state concentration was reached in the second week, with the majority of subjects re Perskaitykite visą dokumentą