DOXEPIN CAPSULE

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

DOXEPIN (DOXEPIN HYDROCHLORIDE)

Tillgänglig från:

AA PHARMA INC

ATC-kod:

N06AA12

INN (International namn):

DOXEPIN

Dos:

10MG

Läkemedelsform:

CAPSULE

Sammansättning:

DOXEPIN (DOXEPIN HYDROCHLORIDE) 10MG

Administreringssätt:

ORAL

Enheter i paketet:

100/500

Receptbelagda typ:

Prescription

Terapiområde:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2018-01-09

Produktens egenskaper

PRODUCT MONOGRAPH
PR DOXEPIN
DOXEPIN HYDROCHLORIDE CAPSULES
10 MG, 25 MG, 50 MG, 75 MG, 100 MG AND 150 MG DOXEPIN
HOUSE STANDARD
ANTIDEPRESSANT AND ANXIOLYTIC
AA PHARMA INC.
DATE OF PREPARATION:
1165 CREDITSTONE ROAD, UNIT #1
DECEMBER 29, 2017
VAUGHAN, ONTARIO
L4K 4N7
_Control No.: 211196_
_ _
1
ACTION
DOXEPIN 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.
COMPARATIVE BIOAVAILABILITY STUDIES
A standard 2-way crossover comparative bioavailability study,
conducted under fasting
conditions, was performed on healthy male volunteers. The results
obtained from 37 volunteers
who completed the study are summarized in the following tables. The
rate and extent of
absorption of doxepin were measured and compared following a single
oral dose ( 1 x 150 mg
capsule) of APO-DOXEPIN (doxepin hydrochloride) 150 mg (Apotex Inc.)
and Sinequan
(desmethyldoxepin) 150 mg capsule (Pfizer Inc.).
Doxepin
(_1 x 150_mg)
From Measured Data
Geometric Mean
Arithmetic Mean (CV%)
Parameter
Test*
Reference
†
Ratio of Geometric Means (%)
90% Confidence Interval (%)
AUC
T
(ng•h/mL)
380
485 (62)
392
495 (66)
97
87 - 107
AUC
I
(ng•h/mL)
441
539 (59)
450
564 (69)
98
90 - 107
C
max
(ng/mL)
39.3
46.7 (53)
43.4
53.9 (71)
91
80 - 104
T
max
§
(h)
2.32 (0.92)
2.19 (0.99)
T
½
§
(h)
12.6 (6.6)
11.9 (6.1)
*Apo-Doxepin (doxepin) 150 mg capsules (Apotex Inc.).
† Sinequan (desmethyl doxepin) 150 mg capsules (Pfizer Inc.) were
purchased in Canada.
§
Expressed as the arithmetic mean (CV%) only.
INDICATIONS
The antidepressant and anxiolytic properties of -DOXEPIN (doxepin
hydrochloride) have been
found to be of value in the drug treatment of:
1.
Psychoneurotic patients with anxiety and/or depressive reactions;
2

Anxiety neurosis asso