NTP-DOXEPIN CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DOXEPIN HYDROCHLORIDE

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

N06AA12

DCI (Dénomination commune internationale):

DOXEPIN

Dosage:

75MG

forme pharmaceutique:

CAPSULE

Composition:

DOXEPIN HYDROCHLORIDE 75MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0131283004; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2015-08-06

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
NTP-DOXEPIN
Doxepin hydrochloride Capsule USP
25 mg, 50 mg, 75 mg, and 100 mg Capsules
ANTIDEPRESSANT AND ANXIOLYTIC AGENT
Teva Canada Limited Date of Preparation:
30 Novopharm Court July 22, 2013
Toronto, Ontario
Canada,M1B 2K9
Control No.: 165997
ACTION
NTP-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 NTP-
DOXEPIN and SINEQUAN
®
150mg Capsules. The pharmacokinetic data calculated for
the NTP-DOXEPIN and SINEQUAN
®
Capsule formulations are tabulated below:
Pharmacokinetic Indices for Trans-Doxepin:
Geometric Mean
Arithmetic Mean (C.V.)
NTP-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.)
NTP-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.)
NTP-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
(ng·h/mL)
72.97
87.11 (74)
71.5