NOVO-DOXEPIN CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DOXEPIN (DOXEPIN HYDROCHLORIDE)

זמין מ:

TEVA CANADA LIMITED

קוד ATC:

N06AA12

INN (שם בינלאומי):

DOXEPIN

כמות:

75MG

טופס פרצבטיות:

CAPSULE

הרכב:

DOXEPIN (DOXEPIN HYDROCHLORIDE) 75MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100/500

סוג מרשם:

Prescription

איזור תרפויטי:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0107703003; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2019-08-08

מאפייני מוצר

PRODUCT MONOGRAPH
PR
NOVO-DOXEPIN
Doxepin hydrochloride Capsule USP
25 mg, 50 mg, 75 mg, 100 mg and 150 mg Capsules
ANTIDEPRESSANT AND ANXIOLYTIC AGENT
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
March 7, 2014
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control # 172120
ACTION
NOVO-DOXEPIN (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.
A comparative, two-way, single-dose bioavailability study was
performed on NOVO-
DOXEPIN and SINEQUAN
®
150mg Capsules. The pharmacokinetic data calculated for
the NOVO-DOXEPIN and SINEQUAN
®
Capsule formulations are tabulated below:
Pharmacokinetic Indices for Trans-Doxepin:
Geometric Mean
Arithmetic Mean (C.V.)
NOVO-DOXEPIN
(1 x 150 mg)
SINEQUAN
®
(1 x 150 mg)
Percentage of
SINEQUAN
®
AUC
T
(ng·h/mL)
454.9
522.8 (52)
518.0
598.8 (56)
88
AUC
I
(ng·h/mL)
544.6
622.0 (57)
614.0
691.2 (51)
89
C
max
(ng/mL)
38.86
44.93 (50)
42.95
50.02 (55)
90
T
max
*
(h)
2.79 (1.63)
2.10 (1.00)
-
T
1/2
*
(h)
22.58 (30.70)
23.06 (22.60)
-
Pharmacokinetic Indices for Trans-N-Desmethyldoxepin:
Geometric Mean
Arithmetic Mean (C.V.)
NOVO-DOXEPIN
(1 x 150 mg)
SINEQUAN
®
(1 x 150 mg)
Percentage of
SINEQUAN
®
AUC
T
(ng·h/mL)
156.0
294.8 (154)
165.7
278.9 (142)
94
AUC
I
(ng·h/mL)
217.0
374.1 (147)
225.9
(349.2 (137)
96
C
max
(ng/mL)
8.25
9.50 (53)
8.41
9.64 (52)
98
T
max
*
(h)
5.72 (6.74)
4.72 (4.31)
-
T
1/2
*
(h)
20.20 (12.17)
20.24 (10.48)
-
* For the T
max
and
T
1/2
parameters these are the arithmetic means (standard deviation).
Pharmacokinetic Indices for Cis-Doxepin:
Geometric Mean
Arithmetic Mean (C.V.)
NOVO-DOXEPIN
(1 x 150 mg)
SINEQUAN
®
(1 x 150 mg)
Percentage of
SINEQUAN
®
AUC
T
(ng·h/mL)
51.42
62.42 (68)
54.05
64.22 (62)
95
AUC
I
(n