NOVO-DOXEPIN CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DOXEPIN (DOXEPIN HYDROCHLORIDE)

제공처:

TEVA CANADA LIMITED

ATC 코드:

N06AA12

INN (국제 이름):

DOXEPIN

복용량:

75MG

약제 형태:

CAPSULE

구성:

DOXEPIN (DOXEPIN HYDROCHLORIDE) 75MG

관리 경로:

ORAL

패키지 단위:

100/500

처방전 유형:

Prescription

치료 영역:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2019-08-08

제품 특성 요약

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