TEVA-NORTRIPTYLINE CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

N06AA10

INN (nume internaţional):

NORTRIPTYLINE

Dozare:

25MG

Forma farmaceutică:

CAPSULE

Compoziție:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 25MG

Calea de administrare:

ORAL

Unități în pachet:

100/500/1000

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0102630001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2019-08-08

Caracteristicilor produsului

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_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
_____________________________________________________________________________________________________________________________
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_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
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