NOVO-BUPROPION SR TABLETS TABLET (EXTENDED-RELEASE)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

BUPROPION HYDROCHLORIDE

Disponibbli minn:

NOVOPHARM LIMITED

Kodiċi ATC:

N06AX12

INN (Isem Internazzjonali):

BUPROPION

Dożaġġ:

150MG

Għamla farmaċewtika:

TABLET (EXTENDED-RELEASE)

Kompożizzjoni:

BUPROPION HYDROCHLORIDE 150MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30/60

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS ANTIDEPRESSANTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0131140003; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2015-10-26

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
PR
NOVO-BUPROPION SR
(BUPROPION HYDROCHLORIDE)
100 mg and 150 mg
Sustained Release Tablets
Antidepressant
Novopharm Limited
Date of Preparation
30 Novopharm Court
September 12, 2007
Toronto ON
M1B 2K9
Control Number: 111917
2
PRODUCT MONOGRAPH
PR
NOVO-BUPROPION SR
(Bupropion hydrochloride)
Sustained Release Tablets
100 mg and 150 mg
Antidepressant
ACTIONS AND CLINICAL PHARMACOLOGY
PHARMACOLOGY
NOVO-BUPROPION SR (Bupropion hydrochloride) is an antidepressant of
the aminoketone class.
It is chemically unrelated to tricyclic, tetracyclic, selective
serotonin re-uptake inhibitors or other
known antidepressant agents. Its structure closely resembles that of
diethylpropion. It is related to
the phenylethylamines.
The mechanism of bupropion's antidepressant activity is unknown but
appears to be mediated by
noradrenergic (and possibly dopaminergic), rather than serotonergic
mechanisms. Preclinical studies
have shown that bupropion blocks noradrenaline (NA) reuptake and
dopamine (DA) reuptake. Its
major metabolite (hydroxybupropion), which in man is present at blood
levels 10-20-fold higher
than bupropion, blocks only NA reuptake.
_In vitro_
, bupropion and its major metabolites had essentially no affinity for
ß-adrenergic,
dopaminergic, GABA, benzodiazepine, 5HT1A, glycine and adenosine
receptors, and only weakly
inhibited α-adrenergic receptors in rat brain, α2-adrenergic, 5HT2,
and muscarinic cholinergic
receptors. High concentrations of bupropion and its major metabolites
did not inhibit MAO-A or
MAO-B activity. Bupropion and its major metabolites had no significant
affinity for the 5HT
transport system.
3
PHARMACOKINETICS
_ABSORPTION _
Bupropion
has
not
been
administered
intravenously
to
humans;
therefore,
the
absolute
bioavailability of bupropion hydrochloride sustained release tablets
in humans has not been
determined. In rat and dog studies, the bioavailability of bupropion
ranged from 5% to 20%.
Following oral administration of bupropion hydrochloride to healthy
volunteers, peak plasma
concen