NU-PAROXETINE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

Dostupné s:

NU-PHARM INC

ATC kód:

N06AB05

INN (Mezinárodní Name):

PAROXETINE

Dávkování:

10MG

Léková forma:

TABLET

Složení:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 10MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Přehled produktů:

Active ingredient group (AIG) number: 0123131003; AHFS:

Stav Autorizace:

CANCELLED (UNRETURNED ANNUAL)

Datum autorizace:

2018-03-28

Charakteristika produktu

0
PRODUCT MONOGRAPH
NU-PAROXETINE
Paroxetine (as Paroxetine Hydrochloride) Tablets
10mg, 20 mg and 30 mg
Antidepressant – Antiobsessional – Antipanic – Anxiolytic Agent
– Social Phobia
(Social Anxiety Disorder) Therapy – Posttraumatic Stress Disorder
Therapy
NU-PHARM INC.
DATE OF PREPARATION:
50 Mural Street, Units 1 & 2
November 28, 2003
Richmond Hill, Ontario
DATE OF REVISION:
L4B 1E4
May 6, 2005
Control Number: 096155
1
_ _
_ _
PRODUCT MONOGRAPH
NU-PAROXETINE
Paroxetine (as Paroxetine Hydrochloride) Tablets
10 mg 20 mg and 30 mg
THERAPEUTIC CLASSIFICATION
Antidepressant – Antiobsessional – Antipanic – Anxiolytic Agent
–
Social Phobia (Social Anxiety Disorder) Therapy – Posttraumatic
Stress Disorder Therapy
ACTIONS AND CLINICAL PHARMACOLOGY
Paroxetine is a potent and selective serotonin (5-hydroxytryptamine,
5-HT) reuptake inhibitor
(SSRI). This activity of the drug on brain neurons is thought to be
responsible for its
antidepressant and anxiolytic action in the treatment of depression,
obsessive-compulsive
disorder (OCD), panic disorder, social phobia (social anxiety
disorder), generalized anxiety
disorder (GAD) and posttraumatic stress disorder (PTSD).
Paroxetine is a phenylpiperidine derivative which is chemically
unrelated to the tricyclic or
tetracyclic antidepressants. In receptor binding studies, paroxetine
did not exhibit significant
affinity for the adrenergic (
α
1
,
α
2
,
β
), dopaminergic, serotonergic (5HT
1
, 5HT
2
), or histaminergic
receptors of rat brain membrane. A weak affinity for the muscarinic
acetylcholine receptor was
evident. The predominant metabolites of paroxetine are essentially
inactive as 5-HT reuptake
inhibitors.
Human Pharmacokinetics:
Paroxetine is well absorbed after oral administration. In healthy
volunteers, the absorption of a
single 30 mg oral dose of paroxetine was not appreciably affected by
the presence or absence of
2
food. Owing to the extensive distribution of paroxetine into the
tissues, less than 1% of the total
drug in the body is believed t