Land: Kanada
Språk: engelska
Källa: Health Canada
NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)
TEVA CANADA LIMITED
N06AA10
NORTRIPTYLINE
10MG
CAPSULE
NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 10MG
ORAL
100/500/1000
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0102630002; AHFS:
CANCELLED POST MARKET
2019-08-08
_____________________________________________________________________________________________________________________________ _ _Pr_ _TEVA-NORTRIPTYLINE _1 of 18_ _ PRODUCT MONOGRAPH PR TEVA-NORTRIPTYLINE (Nortriptlyline Hydrochloride Capsules) 10 mg and 25 mg USP ANTIDEPRESSANT Teva Canada Limited Date of Preparation: 30 Novopharm Court December 7, 2011 Toronto, Ontario M1B 2K9 www.tevacanada.com Submission Control No: 151598 _____________________________________________________________________________________________________________________________ _ _Pr_ _TEVA-NORTRIPTYLINE _2 of 18_ _ PRODUCT MONOGRAPH PR TEVA-NORTRIPTYLINE (Nortriptyline Hydrochloride Capsules) 10 mg and 25 mg THERAPEUTIC CLASSIFICATION Antidepressant ACTION AND CLINICAL PHARMACOLOGY The mood elevating mechanism of tricyclic antidepressants is at present unknown. TEVA- NORTRIPTYLINE (nortriptyline hydrochloride) is not a monoamine oxidase inhibitor. It inhibits the activity of such diverse agents as histamine, 5-hydroxytryptamine, and acetylcholine. It increases the pressor effect of norepinephrine but blocks the pressor response of phenethylamine. Studies suggest that nortriptyline hydrochloride interferes with the transport, release, and storage of catecholamines. Operant conditioning techniques in rats and pigeons suggest that nortriptyline has a combination of stimulant and depressant properties. ABSORPTION: Nortriptyline is the principal active metabolite of amitriptyline. Nortriptyline has a longer plasma half-life than amitriptyline. Nortriptyline is subject to extensive first-pass metabolism in the liver to 10-hydroxynortriptyline, which is active. PLASMA CONCENTRATIONS: Nortriptyline appears to have a specific therapeutic window between 50 and 150 ng per mL within which favourable antidepressant responses occur. Above and below this specific plasma concentration range, there is a poor clinical response. Plasma concentration ______________________________________________________________________________________________________________ Läs hela dokumentet