AMITRIPTYLINE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

AMITRIPTYLINE HYDROCHLORIDE

Dostępny od:

SIVEM PHARMACEUTICALS ULC

Kod ATC:

N06AA09

INN (International Nazwa):

AMITRIPTYLINE

Dawkowanie:

10MG

Forma farmaceutyczna:

TABLET

Skład:

AMITRIPTYLINE HYDROCHLORIDE 10MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/1000

Typ recepty:

Prescription

Dziedzina terapeutyczna:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0101524001; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2018-12-05

Charakterystyka produktu

_Pr_
_AMITRIPTYLINE _
_1 of 10 _
PRODUCT MONOGRAPH
Pr
AMITRIPTYLINE
(Amitriptyline Hydrochloride, USP)
10mg, 25mg, and 50mg tablets
Antidepressant
Sivem Parmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec
Canada H4R 2P7
www.sivem.ca
Date of Preparation:
February 03, 2016
Control Number: 191591
_Pr_
_AMITRIPTYLINE _
_ 2 of 10 _
ACTION
Amitriptyline hydrochloride is a tricyclic antidepressant with
sedative properties. Its
mechanism of action in man is not known. Amitriptyline inhibits the
membrane pump
mechanism responsible for the re-uptake of transmitter amines, such as
norepinephrine and
serotonin, thereby increasing their concentration at the synaptic
clefts of the brain.
Amitriptyline has pronounced anticholinergic properties and produces
EKG changes and
quinidine-like effects on the heart (See ADVERSE REACTIONS). It also
lowers the
convulsive threshold and causes alterations in EEG and sleep patterns.
Orally administered amitriptyline is readily absorbed and rapidly
metabolized. Steady-state
plasma concentrations vary widely and this variation may be
genetically determined.
Amitriptyline is primarily excreted in the urine, mostly in the form
of metabolites, with some
excretion also occurring in the feces.
INDICATIONS
AMITRIPTYLINE (amitriptyline hydrochloride USP) is indicated for the
relief of symptoms of
depressive illness.
CONTRAINDICATIONS
Known hypersensitivity. Amitriptyline should not be given
concomitantly with or within at
least 14 days following the discontinuance of a MAO inhibitor. Then
initiate dosage of
amitriptyline cautiously with gradual increase in dosage until optimum
response is achieved.
Amitriptyline is not recommended during the acute recovery phase
following myocardial
infarction, and in the presence of acute congestive heart failure.
WARNINGS
Arrhythmias, sinus tachycardia, and prolongation of the conduction
time have been reported,
particularly with high doses of amitriptyline. A few instances of
unexpected death have been
reported in patients with cardiovascular disorders. M