TOFRANIL 75MG TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

IMIPRAMINE HYDROCHLORIDE

Disponível em:

NOVARTIS PHARMACEUTICALS CANADA INC

Código ATC:

N06AA02

DCI (Denominação Comum Internacional):

IMIPRAMINE

Dosagem:

75MG

Forma farmacêutica:

TABLET

Composição:

IMIPRAMINE HYDROCHLORIDE 75MG

Via de administração:

ORAL

Unidades em pacote:

30

Tipo de prescrição:

Prescription

Área terapêutica:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Resumo do produto:

Active ingredient group (AIG) number: 0103832004; AHFS:

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2008-07-18

Características técnicas

PRODUCT MONOGRAPH
PR
TOFRANIL*
(IMIPRAMINE HYDROCHLORIDE)
25, 50 AND 75 MG TABLETS
Antidepressant
Novartis Pharmaceuticals Canada Inc.
DATE OF PREPARATION:
385 Bouchard
February 18, 1985
Dorval, Québec
H9S 1A9
DATES OF REVISION:
Control# 133750
June 16, 2010
Pr
TOFRANIL* is a registered trademark
1
PRODUCT MONOGRAPH
NAME OF DRUG
PR
TOFRANIL*
(imipramine hydrochloride)
25, 50 and 75 mg tablets
THERAPEUTIC CLASSIFICATION
Antidepressant
ACTIONS AND CLINICAL PHARMACOLOGY
TOFRANIL*
(imipramine
hydrochloride)
is
a
tricyclic
antidepressant
with
general
pharmacological properties similar to those of structurally related
tricyclic antidepressant drugs
such as amitriptyline and doxepin.
TOFRANIL* possesses anticholinergic properties which are responsible
for certain side effects. The
mechanism of action of TOFRANIL* and other tricyclic antidepressants
is not well established, but it
is
thought
that
it
might
be
related
to
their
action
on
the
transmitter‐uptake
mechanism
of
monoaminergic neurons. The mechanism of action in childhood nocturnal
enuresis is not fully
known.
TOFRANIL* is rapidly and almost completely absorbed from the
gastrointestinal tract. Peak
plasma levels are reached in 2‐5 hours, and plasma half‐life
ranges from 9 to 20 hours. After oral
administration
of
50 mg
three
times
daily
for
ten
days,
the
mean
steady‐state
plasma
concentration was 33‐85 ng/mL for imipramine and 43‐109 ng/mL for
desmethylimipramine, an
active metabolite. Approximately 86% of imipramine is bound to plasma
proteins. It is excreted
primarily as inactive metabolites, up to 80% in the urine and up to
20% in the feces.
Owing to the lower clearance of imipramine in plasma, elderly patients
require lower doses of
TOFRANIL* than patients in younger age groups.
2
INDICATIONS AND CLINICAL USE
TOFRANIL* (imipramine hydrochloride) is indicated for the relief of
symptoms of depression.
CONTRAINDICATIONS
TOFRANIL* (imipramine hydrochloride) is contraindicated in patients
who have known or
suspected
hypersensitivity
to
the
drug
or
its