AVA-FLUVOXAMINE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

FLUVOXAMINE MALEATE

제공처:

AVANSTRA INC

ATC 코드:

N06AB08

INN (국제 이름):

FLUVOXAMINE

복용량:

50MG

약제 형태:

TABLET

구성:

FLUVOXAMINE MALEATE 50MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2014-08-21

제품 특성 요약

0
PRODUCT MONOGRAPH
AVA-FLUVOXAMINE
FLUVOXAMINE MALEATE TABLETS BP
50 MG AND 100 MG
ANTIDEPRESSANT, ANTIOBSESSIONAL AGENT
AVANSTRA INC.
DATE OF PREPARATION:
10761-25
TH NE
FEBRUARY 18, 2011
SUITE 110, BUILDING “B”,
CALGARY, ALBERTA, T2C 3C2
CONTROL #144986
1
PRODUCT MONOGRAPH
AVA-FLUVOXAMINE
Fluvoxamine Maleate Tablets BP
50 mg and 100 mg
THERAPEUTIC CLASSIFICATION
Antidepressant, Antiobsessional Agent
ACTION
The antidepressant and antiobsessional actions of 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
α
1
,
α
2
,
β
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
nonlinear pharmacokinetics over this dose range, i.e., higher doses of
fluvoxamine maleate
produced disproportionately higher concentrations than predicted fr