SINEQUAN CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOXEPIN (DOXEPIN HYDROCHLORIDE)

Available from:

AA PHARMA INC

ATC code:

N06AA12

INN (International Name):

DOXEPIN

Dosage:

10MG

Pharmaceutical form:

CAPSULE

Composition:

DOXEPIN (DOXEPIN HYDROCHLORIDE) 10MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0107703006; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-08-03

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
SINEQUAN*
DOXEPIN HYDROCHLORIDE CAPSULES
10 MG, 25 MG, 50 MG, 75 MG, 100 MG DOXEPIN
MANUFACTURER’S STANDARD
ANTIDEPRESSANT AND ANXIOLYTIC
AA Pharma Inc.
Date of Revision:
1165 Creditstone Road, Unit #1
August 31, 2018
Vaughan, Ontario,
L4K 4N7
Control No.: 210605
2
ACTION
SINEQUAN (doxepin HCl) is a psychotropic agent with antidepressant and
anxiolytic properties. It also
has sedative and anticholinergic effects, and, in the higher dosage
range, it produces peripheral
adrenergic blocking effects. Studies of electroencephalograms in
humans have shown decreases in
amplitude, and amplitude variability, also, the delta, theta and 24-35
CPS activities increased.
INDICATIONS
The antidepressant and anxiolytic properties of SINEQUAN (doxepin HCl)
have been found to be of value
in the drug treatment of:
1.
Psychoneurotic patients with anxiety and/or depressive reactions;
Anxiety neurosis associated with somatic disorders;
Alcoholic patients with anxiety and/or depression.
2.
Psychotic
depression,
including
manic-depressive
illness
(depressed
type)
and
involutional
melancholia.
CLINICAL USE
Controlled clinical trials have confirmed that SINEQUAN (doxepin HCl)
is an effective psychotropic agent
with antidepressant and anxiolytic properties. SINEQUAN has been found
useful in alleviating manifest
anxiety in neurotic patients including those with somatic disorders.
It has also been found useful in
patients with neurotic depression, including those with mixed anxiety
and depression. Patients with
endogenous
or
psychotic
depression,
including
manic-depressive
illness
(depressed
type),
and
involutional melancholia, have also been reported to respond favorably
to SINEQUAN. As adjunctive
medication, it appears to benefit some alcoholic patients with chronic
anxiety and depressive reactions.
As with most psychotropic agents, some patients with these conditions
who have failed to respond to
other appropriate medication may benefit from treatment with SINEQUAN.
In psychoneurotic patients the
following symptoms h