NOVO-DOXEPIN CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DOXEPIN (DOXEPIN HYDROCHLORIDE)

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

N06AA12

INN (Nama Internasional):

DOXEPIN

Dosis:

75MG

Bentuk farmasi:

CAPSULE

Komposisi:

DOXEPIN (DOXEPIN HYDROCHLORIDE) 75MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2019-08-08

Karakteristik produk

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