APO-TRAZODONE TABLETS 50MG

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

TRAZODONE HYDROCHLORIDE

থেকে পাওয়া:

APOTEX INC

এটিসি কোড:

N06AX05

INN (আন্তর্জাতিক নাম):

TRAZODONE

ডোজ:

50MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

TRAZODONE HYDROCHLORIDE 50MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100 & 250 TABLETS

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

SEROTONIN MODULATORS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0115713001; AHFS:

অনুমোদন অবস্থা:

MARKETED

অনুমোদন তারিখ:

1995-12-31

পণ্য বৈশিষ্ট্য

PRODUCT MONOGRAPH
Pr
APO-TRAZODONE
Trazodone Hydrochloride Tablets USP
50 mg and 100 mg
Pr
APO-TRAZODONE D
Trazodone Hydrochloride Tablets USP
150 mg
Antidepressant
APOTEX INC DATE OF REVISION:
150 SIGNET DRIVE
NOVEMBER 21, 2017
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 193799
[1]
PRODUCT MONOGRAPH
Pr
APO-TRAZODONE
Trazodone Hydrochloride Tablets USP
50 mg and 100 mg
Pr
APO-TRAZODONE D
Trazodone Hydrochloride Tablets USP
150 mg
PHARMACOLOGICAL CLASSIFICATION
Antidepressant
ACTION
The mechanism of action of trazodone hydrochloride, a psychoactive
compound with sedative
and antidepressant properties, is unclear in humans.
After oral administration, trazodone hydrochloride is well absorbed,
with mean peak plasma
levels peaking within one-half to two hours after ingestion.
Food enhances, although delays somewhat, absorption. For the period
from 3 to 10 hours after
dosing, the mean plasma elimination half-life is 4.4 hours; and 10 to
34 hours after dosing it is 7
to 8 hours. Metabolism of the drug is extensively metabolized with 3
or 4 major metabolites
having been identified in man.
Approximately 60 to 70% of
14
C-labelled trazodone appeared in the urine within two days,
whereas only 9 to 29% was excreted in the feces over 60 to 100 hours.
At concentrations attained
with therapeutic doses,
trazodone is 89 to 95% protein bound.
A bioavailability study was performed using healthy human volunteers.
The rate and extent of
absorption of trazodone after a single 100 mg oral dose of Desyrel 100
mg tablets and APO-
Trazodone 100 mg tablets was measured and compared. The results are
summarized as follows:
Parameter
APO-TRAZODONE
Desyrel
Ration of Geometric
Means (%)
AUC
T
(ng∙hr/mL)
8230*
8716 (34)**
8725*
9247 (39)**
94.0***
AUC
I
(ng∙hr/mL)
8472*
8961 (34)**
8986*
9505 (38)**
94.0***
C
max
(ng/mL)
1488*
1550 (31)**
1585*
1663 (31)**
93.3***
T
max
(ng∙hr/mL)
0.99 (84)**
0.91 (73)**
-
[2]
t
1/2
(hr)
5.43 (25)**
5.50 (24)**
-
*
Geometric Mean
**
Arithmetic Mean (CV)
***
Based on the least square estimate of the geometric