BCI FLUVOXAMINE TABLETS

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

FLUVOXAMINE MALEATE

Mevcut itibaren:

BAKER CUMMINS INC

ATC kodu:

N06AB08

INN (International Adı):

FLUVOXAMINE

Doz:

50.0MG

Farmasötik formu:

TABLET

Kompozisyon:

FLUVOXAMINE MALEATE 50.0MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0122450002; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2006-10-03

Ürün özellikleri

PRODUCT MONOGRAPH
BCI FLUVOXAMINE TABLETS
(FLUVOXAMINE MALEATE TABLETS, MFR. STD)
50 MG & 100 MG FILM COATED TABLETS
ANTIDEPRESSANT
ANTIOBSESSIONAL AGENT
MANUFACTURER:
IVAX PHARMACEUTICALS INC.
DATE OF PREPARATION:
4400 BISCAYNE BLVD.,
AUGUST 13, 2004
MIAMI, FLORIDA 33137 USA
DISTRIBUTED BY:
BAKER CUMMINS, INC.
1 PLACE VILLE-MARIE, SUITE 3900
MONTREAL, QUEBEC H3B 4M7
CANADA
Control#: 093336
1
PRODUCT MONOGRAPH
BCI FLUVOXAMINE TABLETS
(FLUVOXAMINE MALEATE TABLETS, MFR. STD) 50 MG & 100 MG FILM COATED TABLETS
ANTIDEPRESSANT
ANTIOBSESSIONAL AGENT
ACTION
The antidepressant and antiobsessional actions of BCI Fluvoxamine
Tablets
(fluvoxamine maleate) are believed to be related to its selective
inhibition of presynaptic
serotonin re-uptake in brain neurones.
There is minimum interference with noradrenergic processes, and, in
common with
several other specific inhibitors of serotonin uptake, fluvoxamine
maleate has very little
_in vitro_ affinity for
"
1
,
"
2
,
$
1
, dopamine
2
, histamine
1
, serotonin
1
, serotonin
2
or muscarinic
receptors.
PHARMACOKINETICS
In healthy volunteers, fluvoxamine maleate is well absorbed after oral
administration.
Following a single 100 mg oral dose, peak plasma levels of 31-87 ng/mL
were attained
1.5 to 8 hours post-dose. Peak plasma levels and AUC's (0-72 hours)
are directly
proportionate to dose after single oral doses of 25, 50, and 100 mg.
Following single doses, the mean plasma half-life is 15 hours, and
slightly longer (17-22
hours), during repeated dosing. Steady-state plasma levels are usually
achieved within
10-14 days. The pharmacokinetic profile in the elderly is similar to
that in younger
patients.
2
In a dose proportionality study involving fluvoxamine maleate at 100,
200 and 300
mg/day for 10 consecutive days in 30 normal volunteers, steady state
was achieved
after about a week of dosing. Maximum plasma concentrations at steady
state occurred
within 3-8 hours of dosing and reached concentrations averaging 88,
283 and 546
ng/mL, respectively. Thus, fluvoxamine maleate had no