AG-TRAZODONE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRAZODONE HYDROCHLORIDE

Available from:

ANGITA PHARMA INC.

ATC code:

N06AX05

INN (International Name):

TRAZODONE

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

TRAZODONE HYDROCHLORIDE 100MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0115713002; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-05-16

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
AG-Trazodone
Trazodone Hydrochloride Tablets
Manufacturer’s Standard
50 mg, 100 mg and 150 mg
Antidepressant
ANGITA PHARMA INC. DATE OF PREPARATION:
1310 RUE NOBEL MAY 16, 2023
BOUCHERVILLE, QUEBEC
J4B 5H3
CONTROL NUMBER: 274491
[2]
PRODUCT MONOGRAPH
Pr
AG-Trazodone
Trazodone Hydrochloride Tablets
50 mg, 100 mg and 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.
INDICATIONS AND CLINICAL
USE
AG-Trazodone (trazodone hydrochloride) is of value in the symptomatic
relief of depressive
illness.
CONTRAINDICATIONS
AG-Trazodone (trazodone hydrochloride) is contraindicated in patients
with a known
hypersensitivity to trazodone.
WARNINGS
Priapism has occurred with the use of trazodone. Surgical intervention
was required in
approximately 1/3 of the cases reported and permanent impairment of
erectile function or
impotence resulted in a portion of these cases. Male patients should
immediately discontinue
the
drug and consult their physician if prolonged or inappropriate
erections occur. It would be
advisable for the treating physician to consult an urologist or
appropriate specialist if the
condition persists for more than 24 hours in order to decid