FXT 40 CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE)

Boleh didapati daripada:

SEPRACOR PHARMACEUTICALS INC

Kod ATC:

N06AB03

INN (Nama Antarabangsa):

FLUOXETINE

Dos:

40MG

Borang farmaseutikal:

CAPSULE

Komposisi:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 40MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0116847004; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2011-08-03

Ciri produk

PRODUCT MONOGRAPH
FXT 40
FLUOXETINE CAPSULES USP
40 MG (AS FLUOXETINE HYDROCHLORIDE)
ANTIDEPRESSANT/ANTIOBSESSIONAL/ANTIBULIMIC
MANUFACTURED BY:
Sepracor Pharmaceuticals, Inc.
6790 Century Ave.,
Suite 100
Mississauga, ON
CANADA
L5N 2V8
Control#: 132258
DATE OF PREPARATION:
September 2, 2009
2
NAME OF DRUG
FXT 40
Fluoxetine Capsules USP
40 mg (as fluoxetine hydrochloride)
THERAPEUTIC CLASSIFICATION
Antidepressant/Antiobsessional/Antibulimic Agent
ACTIONS
The antidepressant, antiobsessional, and antibulimic actions of FXT
(Fluoxetine Capsules USP) are
presumed to be linked to its ability to selectively inhibit the
neuronal reuptake of serotonin. At
clinically relevant doses fluoxetine blocks the uptake of serotonin
into human platelets. Antagonism
of muscarinic, histaminergic and
α
1
-adrenergic receptors has been hypothesized to be associated
with various anticholinergic, sedative and cardiovascular effects of
classical tricyclic antidepressant
drugs. In vitro receptor binding studies have demonstrated that
fluoxetine binds to these and other
membrane receptors [opiate, serotonergic (5-HT
1
, 5-HT
2
), adrenergic
(α
1
, α
2
, β)
and dopaminergic]
much less potently than do the tricyclic drugs.
PHARMACOKINETICS:
Fluoxetine is well absorbed after oral administration. In man,
following a single oral 40 mg dose,
peak plasma concentrations of fluoxetine from 15 to 55 ng/mL are
observed after 6 to 8 hours. Food
does not appear to affect the systemic bioavailability of fluoxetine,
although it may delay its
absorption inconsequentially. Thus fluoxetine may be administered with
or without food.
Fluoxetine is extensively metabolized in the liver to norfluoxetine,
and other unidentified
metabolites. The pharmacological activity of norfluoxetine, which is
formed by demethylation of
fluoxetine appears to be similar to that of the parent drug.
Norfluoxetine contributes to the long
3
duration of action of fluoxetine. The primary route of elimination
appears to be hepatic
metabolism to inactive metabolites excreted by the kid