SIG-CITALOPRAM TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Available from:

SIGMACON LIFESCIENCES INC

ATC code:

N06AB04

INN (International Name):

CITALOPRAM

Dosage:

40MG

Pharmaceutical form:

TABLET

Composition:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG

Administration route:

ORAL

Units in package:

30/100/1000

Prescription type:

Prescription

Therapeutic area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0136243002; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2021-12-01

Summary of Product characteristics

PRODUCT MONOGRAPH
_SIG-_CITALOPRAM
Citalopram Tablets
20 mg & 40 mg Citalopram as Citalopram Hydrobromide
USP
ANTIDEPRESSANT
Sigmacon Lifesciences Inc.
436 Limestone Crescent
North York, Ontario
M3J 2S4
Date of Preparation:
March 10, 2009
Submission Control Number: 128250
2
NAME OF DRUG
_Sig-_
Citalopram
Citalopram Tablets USP
20 mg & 40 mg citalopram as citalopram hydrobromide
THERAPEUTIC CLASSIFICATION
Antidepressant
ACTION AND CLINICAL PHARMACOLOGY
_Sig-_
CITALOPRAM (citalopram hydrobromide) is a highly selective and potent
serotonin
(5-hydroxytryptamine, 5-HT) reuptake inhibitor with minimal effects on
the neuronal reuptake of
norepinephrine (NE) and dopamine (DA). The ability of citalopram to
potentiate serotonergic
activity in the central nervous system
_via_
inhibition of the neuronal reuptake of serotonin is
thought to be responsible for its antidepressant action. Tolerance to
the inhibition of serotonin
reuptake is not induced by long-term (14 days) treatment of rats with
citalopram.
Citalopram has no or very low affinity for a series of receptors
including serotonin 5-HT
1A
, 5-
HT
2
, dopamine D
1
and D
2
, α
1
-, α
2
-, β-adrenergic, histamine H
1
, muscarinic cholinergic,
benzodiazepine, gamma aminobutyric acid (GABA) and opioid receptors.
P
HARMACOKINETICS
ABSORPTION
Following the administration of a single oral dose of citalopram (40
mg) to healthy male
volunteers, peak blood levels occurred at about 4 hours (range 1 to 6
hours). The absolute
bioavailability of citalopram was about 80% (range 52 to 93%) relative
to an intravenous dose.
Absorption was not affected by food.
DISTRIBUTION
After intravenous infusion in healthy male volunteers, the apparent
volume of distribution (V
d
)β
was about 12 L/kg (range 9-17 L/kg), indicating a pronounced tissue
distribution; (V
d
)β oral was
about 17 L/kg (range 14-21 L/kg). The binding of citalopram and its
demethylated metabolites
to human plasma proteins is about 80%.
3
STEADY-STATE
The single- and multiple-dose pharmacokinetics of citalopram are
linear