RATIO-FLUVOXAMINE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

FLUVOXAMINE MALEATE

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

N06AB08

INN (International Nazwa):

FLUVOXAMINE

Dawkowanie:

100MG

Forma farmaceutyczna:

TABLET

Skład:

FLUVOXAMINE MALEATE 100MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0122450001; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2018-05-18

Charakterystyka produktu

PRODUCT
MONOGRAPH
RATIO-FLUVOXAMINE
FLUVOXAMINE MALEATE
50 MG AND 100 MG FILM COATED, SCORED
TABLETS
ANTIDEPRESSANT
ANTIOBSESSIONAL AGENT
TEVA CANADA LIMITED DATE OF PREPARATION:
30 NOVOPHARM COURT MAY 31, 2013
TORONTO, ONTARIO
CANADA, M1B 2K9
CONTROL #: 165097
2
PRODUCT MONOGRAPH
ratio-FLUVOXAMINE
(FLUVOXAMINE MALEATE)
50 MG AND 100 MG FILM COATED, SCORED
TABLETS
ANTIDEPRESSANT
ANTIOBSESSIONAL AGENT
ACTION
The antidepressant and antiobsessional actions of RATIO-FLUVOXAMINE
(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 Alpha
1
, Alpha
2
, Beta
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 100mg.
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.
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
3
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 nonlinear pharmacokinetics
over this dose
range, i.e., higher doses of fluvoxamine maleate produced
disproportionately higher
concentrations