TEVA-AMITRIPTYLINE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

AMITRIPTYLINE HYDROCHLORIDE

Dostopno od:

TEVA CANADA LIMITED

Koda artikla:

N06AA09

INN (mednarodno ime):

AMITRIPTYLINE

Odmerek:

50MG

Farmacevtska oblika:

TABLET

Sestava:

AMITRIPTYLINE HYDROCHLORIDE 50MG

Pot uporabe:

ORAL

Enote v paketu:

30/100/1000

Tip zastaranja:

Prescription

Terapevtsko območje:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Povzetek izdelek:

Active ingredient group (AIG) number: 0101524003; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2011-11-22

Lastnosti izdelka

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets, USP
10 mg, 25 mg, and 50 mg
Antidepressant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
August 11, 2020
Control Number: 235422
PRODUCT MONOGRAPH
TEVA-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets, USP
10 mg, 25 mg, and 50 mg
THERAPEUTIC CLASSIFICATION
Antidepressant
ACTIONS AND CLINICAL PHARMACOLOGY
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 AND CLINICAL USE
TEVA-AMITRIPTYLINE (amitriptyline hydrochloride) is indicated in the
drug management of depressive
illness.
TEVA-AMITRIPTYLINE may be used in depressive illness of psychotic or
endogenous nature and in
selected patients with neurotic depression. Endogenous depression is
more likely to be alleviated than are
other depressive states. TEVA-AMITRIPTYLINE, because of its sedative
action, is also of value in
alleviating the anxiety component of depression.
As with other tricyclic antidepressants, TEVA-AMITRIPTYLINE may
precipitate hypomanic episodes in
patients with bipolar depression. These drugs are not indicated in
mild depressive stat